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  • HP:0002664: Neoplasm
  • Pneumonia (359) Respiratory tract infection (38) Neoplasm (36) Abnormality of the cardiovascular system (34) Diabetes mellitus (33) Depressivity (29) Acute kidney injury (27) Hypoxemia (26) Hypertension (24) Abnormal lung morphology (24) Thromboembolism (22) Anosmia (20) Myocardial infarction (20) Arthritis (19) Type II diabetes mellitus (18) Stroke (16) Pulmonary embolism (16) Mental deterioration (15) Abnormality of coagulation (15) Pulmonary fibrosis (15) Chronic pulmonary obstruction (15) Abnormality of the kidney (14) Autistic behavior (14) Rheumatoid arthritis (14) Leukemia (14) Interstitial pneumonitis (14) Pulmonary obstruction (14) Asthma (13) Chronic pain (13) Congestive heart failure (12) Deep venous thrombosis (12) Neoplasm of the lung (12) Autism (11) Obesity (11) Respiratory distress (11) Colitis (11) Ulcerative colitis (11) Crohn's disease (11) Type I diabetes mellitus (10) Abnormality of the liver (9) Coronary artery atherosclerosis (9) Inflammation of the large 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    HP:0002664: Neoplasm

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (66)


    Name (Synonyms) Correlation
    drug2301 Meaning Centered Psychotherapy for Latinos Wiki 0.24
    drug2302 Meaning Centered Psychotherapy for Latinos for Waitlist Control Patients Wiki 0.24
    drug1582 Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale Wiki 0.24
    Name (Synonyms) Correlation
    drug3061 Pre-assessment questionnaire Wiki 0.24
    drug3181 Quality-of-Life Assessment Wiki 0.22
    drug545 Best Practice Wiki 0.22
    drug3193 Questionnaire Administration Wiki 0.18
    drug2647 ONC201 Wiki 0.17
    drug2767 PF-06939999 monotherapy Wiki 0.17
    drug3202 Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. Wiki 0.17
    drug3985 Therapeutic Exercise and Education Wiki 0.17
    drug1124 D-1553 Wiki 0.17
    drug2596 Non-Anchoring Strategy Control Wiki 0.17
    drug921 Ciclesonide Wiki 0.17
    drug3179 Quality of life assessment Wiki 0.17
    drug3372 Rintatolimod Wiki 0.17
    drug4293 Web-based REDCap survey Wiki 0.17
    drug424 Azithromycin 250 MG Oral Capsule Wiki 0.17
    drug286 Anatomic Pulmonary Resection Wiki 0.17
    drug2933 Placebo Administration Wiki 0.17
    drug1542 Fixed Anchoring Strategy Wiki 0.17
    drug1873 IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care. Wiki 0.17
    drug1305 EHR-based Clinician Jumpstart Wiki 0.17
    drug3866 TAK-981 Wiki 0.17
    drug233 Aerosolized All trans retinoic acid Wiki 0.17
    drug140 ASP8374 Wiki 0.17
    drug496 BRII-196 Wiki 0.17
    drug2765 PF-06939999 dose escalation Wiki 0.17
    drug2870 Peripheral venous ultrasound Wiki 0.17
    drug4448 ctDNA blood sampling Wiki 0.17
    drug4584 modification of the planned therapeutic management Wiki 0.17
    drug2731 Osimertinib Wiki 0.17
    drug3199 Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity index Wiki 0.17
    drug3780 Stereotactic Radiotherapy Wiki 0.17
    drug3286 Recombinant Interferon Alfa-2b Wiki 0.17
    drug3735 Standard of Care Treatment Wiki 0.17
    drug2795 PT-PCR test for SARS-CoV-2 Wiki 0.17
    drug2667 Obvio-19 app Wiki 0.17
    drug1416 Erlotinib Wiki 0.17
    drug231 Aerosolized 13 cis retinoic acid Wiki 0.17
    drug3467 SCH Intervention Wiki 0.17
    drug1118 CytoSorb 300 mL device Wiki 0.17
    drug1935 Informed consent Wiki 0.17
    drug2766 PF-06939999 in combination with docetaxel Wiki 0.17
    drug2879 Personalized Anchoring Strategy Wiki 0.17
    drug374 Association atezolizumab + BDB001+ RT Wiki 0.12
    drug2732 Other Wiki 0.12
    drug1800 Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki 0.12
    drug3941 Telisotuzumab vedotin Wiki 0.12
    drug1876 Ibrutinib Wiki 0.12
    drug1158 Data Collection Wiki 0.12
    drug3857 T3011 Wiki 0.12
    drug2114 Leflunomide Wiki 0.12
    drug895 Chemotherapy Wiki 0.12
    drug2852 Pembrolizumab Wiki 0.12
    drug2979 Placebo oral capsule Wiki 0.10
    drug582 Biospecimen Collection Wiki 0.10
    drug3830 Survey Administration Wiki 0.10
    drug373 Association atezolizumab + BDB001 + RT Wiki 0.08
    drug2170 Lopinavir/Ritonavir Wiki 0.08
    drug2567 Nivolumab Wiki 0.08
    drug832 Camostat Mesilate Wiki 0.06
    drug4025 Tocilizumab Wiki 0.05
    drug3738 Standard of care Wiki 0.03
    drug2981 Placebo oral tablet Wiki 0.03
    drug2916 Placebo Wiki 0.03

    Correlated MeSH Terms (46)


    Name (Synonyms) Correlation
    D009369 Neoplasms, NIH 1.00
    D019337 Hematologic Neoplasms NIH 0.24
    D046152 Gastrointestinal Stromal Tumors NIH 0.17
    Name (Synonyms) Correlation
    D000741 Anemia, Aplastic NIH 0.17
    D014594 Uterine Neoplasms NIH 0.17
    D014625 Vaginal Neoplasms NIH 0.17
    D010265 Paraproteinemias NIH 0.17
    D012878 Skin Neoplasms NIH 0.17
    D012983 Soft Tissue Neoplasms NIH 0.17
    D008998 Monoclonal Gammopathy of Undetermined Significance NIH 0.17
    D014846 Vulvar Neoplasms NIH 0.17
    D008218 Lymphocytosis NIH 0.17
    D001661 Biliary Tract Neoplasms NIH 0.17
    D001749 Urinary Bladder Neoplasms NIH 0.17
    D009362 Neoplasm Metastasis NIH 0.15
    D008175 Lung Neoplasms NIH 0.14
    D007676 Kidney Failure, Chronic NIH 0.13
    D002583 Uterine Cervical Neoplasms NIH 0.12
    D009196 Myeloproliferative Disorders NIH 0.12
    D009190 Myelodysplastic Syndromes NIH 0.12
    D010051 Ovarian Neoplasms NIH 0.10
    D016491 Peripheral Vascular Diseases NIH 0.10
    D018358 Neuroendocrine Tumors NIH 0.10
    D029424 Pulmonary Disease, Chronic Obstructive NIH 0.09
    D058729 Peripheral Arterial Disease NIH 0.08
    D014652 Vascular Diseases NIH 0.08
    D008103 Liver Cirrhosis, NIH 0.08
    D064726 Triple Negative Breast Neoplasms NIH 0.07
    D015179 Colorectal Neoplasms NIH 0.07
    D001943 Breast Neoplasms NIH 0.07
    D051437 Renal Insufficiency, NIH 0.07
    D003324 Coronary Artery Disease NIH 0.06
    D006333 Heart Failure NIH 0.05
    D017563 Lung Diseases, Interstitial NIH 0.04
    D008173 Lung Diseases, Obstructive NIH 0.04
    D002908 Chronic Disease NIH 0.04
    D020521 Stroke NIH 0.04
    D013923 Thromboembolism NIH 0.04
    D008171 Lung Diseases, NIH 0.03
    D007239 Infection NIH 0.02
    D012127 Respiratory Distress Syndrome, Newborn NIH 0.01
    D055371 Acute Lung Injury NIH 0.01
    D012128 Respiratory Distress Syndrome, Adult NIH 0.01
    D003141 Communicable Diseases NIH 0.01
    D011014 Pneumonia NIH 0.01
    D018352 Coronavirus Infections NIH 0.01

    Correlated HPO Terms (30)


    Name (Synonyms) Correlation
    HP:0001909 Leukemia HPO 0.18
    HP:0008069 Neoplasm of the skin HPO 0.17
    HP:0100574 Biliary tract neoplasm HPO 0.17
    Name (Synonyms) Correlation
    HP:0100650 Vaginal neoplasm HPO 0.17
    HP:0030416 Vulvar neoplasm HPO 0.17
    HP:0100827 Lymphocytosis HPO 0.17
    HP:0012133 Erythroid hypoplasia HPO 0.17
    HP:0010784 Uterine neoplasm HPO 0.17
    HP:0009725 Bladder neoplasm HPO 0.17
    HP:0100723 Gastrointestinal stroma tumor HPO 0.17
    HP:0100526 Neoplasm of the lung HPO 0.14
    HP:0005547 Myeloproliferative disorder HPO 0.12
    HP:0030079 Cervix cancer HPO 0.12
    HP:0002863 Myelodysplasia HPO 0.12
    HP:0100634 Neuroendocrine neoplasm HPO 0.10
    HP:0100615 Ovarian neoplasm HPO 0.10
    HP:0006510 Chronic pulmonary obstruction HPO 0.09
    HP:0001395 Hepatic fibrosis HPO 0.08
    HP:0100834 Neoplasm of the large intestine HPO 0.07
    HP:0000083 Renal insufficiency HPO 0.07
    HP:0003002 Breast carcinoma HPO 0.07
    HP:0004950 Peripheral arterial stenosis HPO 0.06
    HP:0001677 Coronary artery atherosclerosis HPO 0.06
    HP:0001635 Congestive heart failure HPO 0.05
    HP:0006515 Interstitial pneumonitis HPO 0.04
    HP:0006536 Pulmonary obstruction HPO 0.04
    HP:0001297 Stroke HPO 0.04
    HP:0001907 Thromboembolism HPO 0.04
    HP:0002088 Abnormal lung morphology HPO 0.03
    HP:0002090 Pneumonia HPO 0.01

    Clinical Trials

    Navigate: Correlations   HPO

    There are 36 clinical trials


    1 A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

    This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination with osimertinib, erlotinib, and nivolumab in participants with advanced solid tumors likely to express c-Met. Enrollment is closed for the monotherapy arms, Arm A, and Arm D.

    NCT02099058
    Conditions
    1. Advanced Solid Tumors Cancer
    Interventions
    1. Drug: Osimertinib
    2. Drug: Nivolumab
    3. Drug: Telisotuzumab vedotin
    4. Drug: Telisotuzumab vedotin
    5. Drug: Erlotinib
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

    Measure: Number of Participants with Adverse Events

    Time: Up to 24 Months

    Description: The RPTD of ABBV-399 when administered as monotherapy and in combination with osimertinib, erlotinib or nivolumab will be determined during the dose escalation phase of the study. RPTD will be determined using available safety and pharmacokinetics data.

    Measure: Recommended Phase 2 Dose (RPTD) of ABBV-399 when Administered as Monotherapy and in Combination with Osimertinib, Erlotinib or Nivolumab

    Time: Up to 24 Months

    Description: AUC (0-t) = Area under the serum concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.

    Measure: Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)

    Time: Up to 24 months

    Description: Maximum observed plasma concentration (Cmax).

    Measure: Maximum observed plasma concentration (Cmax)

    Time: Up to 24 months

    Description: Time to Cmax (Tmax).

    Measure: Time to Cmax (Tmax)

    Time: Up to 24 months

    Description: Terminal elimination half life.

    Measure: Terminal elimination half life

    Time: Up to 24 months
    2 CSP #2005 - Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial (VALOR)

    Patients with stage I non-small cell lung cancer have been historically treated with surgery whenever they are fit for an operation. However, an alternative treatment known as stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors believe both are good treatments and are therefore conducting this study to determine if one may be possibly better than the other.

    NCT02984761
    Conditions
    1. Lung Neoplasm
    Interventions
    1. Radiation: Stereotactic Radiotherapy
    2. Procedure: Anatomic Pulmonary Resection
    MeSH:Neoplasms Lung Neoplasms
    HPO:Neoplasm Neoplasm of the lung

    Primary Outcomes

    Description: Survival estimates will include death from any cause.

    Measure: Overall Survival

    Time: From date of randomization through study completion, up to 10 years

    Secondary Outcomes

    Description: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Lung Cancer (LC 13) survey instruments will assess patients' general state of physical, social/family, emotional and functional well-being.

    Measure: Patient reported health-related quality of life

    Time: 5 years

    Description: The St George's Respiratory Questionnaire will evaluate respiratory symptoms, activity limitations from breathlessness, and impact of respiratory function on social and psychological functioning.

    Measure: Respiratory Symptoms

    Time: 5 years

    Description: The EQ-5D-5L (EuroQOL-5D) survey will measure quality adjusted life years.

    Measure: Health State Utilities

    Time: 5 years

    Description: Cause of death will be determined by an independent adjudication committee.

    Measure: Lung cancer mortality

    Time: From date of randomization until date of death from any cause, assessed up to 10 years.

    Description: Post-treatment surveillance imaging will evaluate patients every 6 months for local, regional, and/or distant disease control.

    Measure: Tumor patterns of failure

    Time: 5 years

    Description: The Forced Expiratory Volume at 1 second (FEV1) will evaluate an objective measure of breathing function.

    Measure: Respiratory Function

    Time: 5 years
    3 Phase 2 Study of ONC201 in Neuroendocrine Tumors

    The purpose of this study is to learn if a new drug, ONC201 can make tumors become smaller or go away completely. Investigators also want to learn if ONC201 can prevent new deposits of cancer from appearing in new places in participants (metastases). A phase 2 study of ONC201 in PC-PG (pheochromocytoma-paraganglioma) and other neuroendocrine tumors will determine whether inhibition of DRD2 (a member of the dopamine receptor family) is safe in unresectable, recurrent, locally advanced, refractory, or metastatic neuroendocrine cancers including PC-PG, desmoplastic small round cell tumor (DSRCT), Ewing sarcoma (PNET) or any other neuroendicrine tumor with a catecholamine or dopamine biomarker or autocrine or paracrine dependence on dopamine including cholangiocarcinoma and adrenal cortical carcinoma. ONC201 is an investigational (experimental) agent and has a favorable safety profile in phase 1 and early phase 2 clinical trials in advanced cancers. This study design has been chosen to see whether ONC201 is associated with reduction of anti-hypertension medications, safety and significant efficacy against neuroendocrine tumors, especially PC-PG.

    NCT03034200
    Conditions
    1. Recurrent Neuroendocrine Tumor
    2. Metastatic Neuroendocrine Tumor
    Interventions
    1. Drug: ONC201
    MeSH:Neoplasms Neuroendocrine Tumors
    HPO:Neoplasm Neuroendocrine neoplasm

    Primary Outcomes

    Description: Complete Response (CR) Disappearance or fibrosis of all target lesions. Any pathologic lymph nodes must have reduction in short axis to <10mm and standardized uptake value (SUV) is <4. Partial Response (PR) At least 30% decrease in sum of longest diameters of target lesions (compared to initial on study baseline) and any decrease in SUV in Fludeoxyglucose 18F (18FDG) imaging Stable disease (SD) 0-29% decrease in sum of longest diameters of target lesions (compared to initial on study baseline) or 0-19% increase in sum of longest diameters of target lesions (compared to initial on study baseline). SUV may increase or decrease Progressive disease 20% or more increase of sum of longest diameters of target lesions (compared to initial on study baseline). The sum must also be at an increase of at least 5mm or one or more new lesions that are considered metastatic disease

    Measure: Tumor response according to RECIST Criteria

    Time: Up to 1 Year

    Secondary Outcomes

    Description: Average time from beginning of treatment to progression, death, or one year, whichever comes first. An underlying clinical benefit rate of 25% would indicate that ONC201 has a therapeutic effect, whereas an underlying rate <5% would indicate a lack of activity

    Measure: Average duration of lack of progression: Clinical response

    Time: Up to 1 Year

    Description: time from beginning of treatment until death, or one year, whichever comes first.

    Measure: Overall survival

    Time: Up to 1 Year

    Description: to achieve this secondary endpoint of anti-hypertensive medication reduction in PC-PG subjects (N=12) data at 3 months will be required. An underlying clinical benefit rate of 25% would indicate that ONC201 has a therapeutic effect, whereas an underlying rate <5% would indicate a lack of activity

    Measure: Average change in anti-hypertensive medication

    Time: from beginning of treatment to 3 months
    4 A Phase 1b Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

    The primary purpose of this study is to evaluate the tolerability and safety profile of ASP8374 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumor malignancies. Also primary purpose is to characterize the pharmacokinetic profile of ASP8374 when administered as a single agent and in combination with pembrolizumab. Last primary purpose of this study is to determine the recommended Phase 2 dose (RP2D) of ASP8374 when administered as a single agent and in combination with pembrolizumab. The secondary purpose of this study is to evaluate the anti-tumor effect (objective response rate [ORR], duration of response [DOR], persistence of response after discontinuation, and disease control rate [DCR]) of ASP8374 when administered as a single agent and in combination with pembrolizumab.

    NCT03260322
    Conditions
    1. Advanced Solid Tumors
    Interventions
    1. Drug: ASP8374
    2. Drug: Pembrolizumab
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: DLT as graded using National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] Version 4.03. The DLT observation period may be increased if deemed appropriate by the Dose Escalation and Safety Committee

    Measure: Safety and tolerability assessed by Dose Limiting Toxicity (DLT)

    Time: Up to 21 days

    Description: Initial and re-treatment. An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product

    Measure: Safety and tolerability assessed by adverse events (AEs)

    Time: Up to 30 days following the last dose of study drug or until initiation of a new anti-cancer treatment, whichever comes first of each treatment period (Up to a maximum of 52 weeks)

    Description: Initial and re-treatment. Most frequent immune-related AEs include rash, oral mucositis, dry mouth, colitis/diarrhea, hepatitis, pneumonitis, and endocrinopathies

    Measure: Safety and tolerability assessed by immune-related AEs (irAEs)

    Time: Up to 30 days following the last dose of study drug or until initiation of a new anti-cancer treatment, whichever comes first of each treatment period (Up to a maximum of 52 weeks)

    Description: Initial and re-treatment. Adverse event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event

    Measure: Safety and tolerability assessed by serious adverse events (SAEs)

    Time: Up to 90 days following the last dose of study drug or until initiation of a new anti-cancer treatment, whichever comes first of each treatment period (Up to a maximum of 60 weeks)

    Description: Initial and re-treatment. Number of participants with potentially clinically significant laboratory values. The laboratory tests include hematology, biochemistry, urine dipstick, pregnancy test, thyroid stimulating hormone (TSH) and free T4; Hepatitis B and C; Testosterone and prostate-specific antigen (PSA) (metastatic castration resistant prostate cancer (mCRPC) only)

    Measure: Number of participants with laboratory value abnormalities and/or adverse events related to treatment

    Time: Up to 30 days from last dose in safety follow up period for each treatment period (Up to a maximum of 52 weeks)

    Description: Initial and re-treatment. ECGs should be obtained after the participant has rested quietly and is awake in a fully supine position (or semi-recumbent, if supine is not tolerated) for 10 minutes before the first ECG from a triplicate or single ECG. Any clinically significant adverse changes on the ECG will be reported as (serious) Adverse Event

    Measure: Safety and tolerability assessed by 12-lead electrocardiogram (ECG)

    Time: Up to end of treatment (up to 48 weeks for each treatment period)

    Description: Initial and re-treatment. Number of participants with potentially clinically significant vital sign values. Vital signs will include systolic and diastolic blood pressure, radial pulse and temperature. All vital signs will be measured with the subject in the sitting or supine position

    Measure: Number of participants with vital signs abnormalities and/or adverse events related to treatment

    Time: Up to 90 days from last dose in safety follow up period for each treatment period (Up to a maximum of 60 weeks)

    Description: Initial and re-treatment. Standard, full physical examinations will be performed at screening to assess general appearance, skin, eyes, ears, nose, throat, neck, cardiovascular system, chest and lungs, abdomen, musculoskeletal system, neurologic status, mental status, and lymphatic system

    Measure: Number of participants with Physical Exam abnormalities and/or adverse events related to treatment

    Time: Up to end of treatment (up to 48 weeks for each treatment period)

    Description: Initial and re-treatment. The eastern cooperative oncology group (ECOG) Scale [Oken, 1982] will be used to assess performance status.0 = Fully active, able to carry on all predisease performance without restriction; 1=Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature; 2= Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3= Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4= Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair

    Measure: Safety and tolerability assessed by ECOG performance status

    Time: Up to 30 days from last dose in safety follow up period of each treatment period (Up to a maximum of 52 weeks)

    Description: AUClast: area under the concentration-time curve from the time of dosing to the last measurable concentration. AUClast will be derived from the PK serum samples collected.

    Measure: Pharmacokinetics (PK) of ASP8374 in serum: AUClast (Initial treatment, escalation cohorts in monotherapy only)

    Time: Cycle 1 and 7: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdose (for cycle 1 only)

    Description: AUCinf: area under the concentration-time curve from the time of dosing extrapolated to time infinity. AUCinf will be derived from the PK serum samples collected.

    Measure: Pharmacokinetics (PK) of ASP8374 in serum: AUCinf (Initial treatment, escalation cohorts in monotherapy only)

    Time: Cycle 1: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdose (for cycle 1 only)

    Description: AUCtau: Area under the concentration-time curve from the time of dosing to the start of the next dosing interval. AUCtau will be derived from the PK serum samples collected.

    Measure: Pharmacokinetics (PK) of ASP8374 in serum: AUCtau (Initial treatment, escalation cohorts in monotherapy only)

    Time: Cycle 1 and 7: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdose (for cycle 1 only)

    Description: Cmax: maximum concentration. Cmax will be derived from the PK serum samples collected.

    Measure: Pharmacokinetics (PK) of ASP8374 in serum: Cmax (Initial treatment, escalation cohorts in monotherapy only)

    Time: Cycle 1 and 7: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdose (cycle 1 only)

    Description: Ctrough: Trough concentration. Ctrough will be derived from the PK serum samples collected.

    Measure: Pharmacokinetics (PK) of ASP8374 in serum: Ctrough (Initial treatment, escalation and expansion cohorts in both monotherapy and combination therapy)

    Time: Cycle 2, 4, 7, 10 and 15: day 1: predose 0 hr

    Description: Ctrough: Trough concentration. Ctrough will be derived from the PK serum samples collected.

    Measure: Pharmacokinetics (PK) of pembrolizumab in serum: Ctrough (Initial treatment, escalation cohorts in combination therapy)

    Time: Cycle 2, 4, 7, 10 and 15: day 1: predose 0 hr

    Description: Ctrough: Trough concentration. Ctrough will be derived from the PK serum samples collected.

    Measure: Pharmacokinetics (PK) of ASP8374 in serum: Ctrough (Re-treatment, escalation and expansion cohorts in both monotherapy and combination therapy)

    Time: Cycle 5, 10 and 15: day 1: predose 0 hr

    Description: tmax: time of maximum concentration. tmax will be derived from the PK serum samples collected.

    Measure: Pharmacokinetics (PK) of ASP8374 in serum: tmax (Initial treatment, escalation cohorts in monotherapy only)

    Time: Cycle 1 and 7: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdose (cycle 1 only)

    Description: t1/2: terminal elimination half-life. t1/2 will be derived from the PK serum samples collected.

    Measure: Pharmacokinetics (PK) of ASP8374 in serum: t1/2 (Initial treatment, escalation cohorts in monotherapy only)

    Time: Cycle 1: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdose

    Description: CL: Clearance. CL will be derived from the PK serum samples collected.

    Measure: Pharmacokinetics (PK) of ASP8374 in serum: CL (Initial treatment, escalation cohorts in monotherapy only)

    Time: Cycle 1 and 7: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdose (cycle 1 only)

    Description: Vz: Volume of distribution after intravenous dosing during the terminal elimination phase. Vz will be derived from the PK serum samples collected.

    Measure: Pharmacokinetics (PK) of ASP8374 in serum: Vz (Initial treatment, escalation cohorts in monotherapy only)

    Time: Cycle 1: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdose

    Description: Vss: Volume of distribution at steady state after intravenous dosing. Vss will be derived from the PK serum samples collected.

    Measure: Pharmacokinetics (PK) of ASP8374 in serum: Vss (Initial treatment, escalation cohorts in monotherapy only)

    Time: Cycle 7: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose

    Secondary Outcomes

    Description: Initial and re-treatment. 'Immune' Response Evaluation Criteria in Solid Tumors (iRECIST). ORR is defined as the proportion of participants for each dose level whose best overall response is rated as confirmed CR or PR

    Measure: Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST

    Time: Up to end of follow up period (up to 105 weeks) of each treatment period

    Description: Initial and re-treatment. DOR will be calculated only for the subgroup of participants with confirmed response CR/PR

    Measure: Duration of response (DOR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST

    Time: Up to end of follow up period (up to 105 weeks) of each treatment period

    Description: Initial and re-treatment. Persistence of response after discontinuation is defined for participants who discontinued the treatment and responded to the treatment per iRECIST only

    Measure: Persistence of response after discontinuation by iRECIST

    Time: Up to end of follow up period (up to 105 weeks) of each treatment period

    Description: Initial and re-treatment. DCR is defined as the proportion of participants for each dose level whose best overall response is rated as confirmed CR, PR or Stable Disease (SD)

    Measure: Disease control rate (DCR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST

    Time: Up to End of follow up period (up to 105 weeks) of each treatment period
    5 An Open Label, Dose-Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TAK-981 in Adult Patients With Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies and in a Subset With Coronavirus Disease 2019

    The primary objective of this study is to evaluate the safety and tolerability of TAK-981 as a single agent in participants with advanced or metastatic solid tumors and lymphomas in dose escalation and cancer treatment expansions, and to assess change in acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load within 8 days of TAK-981 administration in COVID expansion.

    NCT03648372
    Conditions
    1. Neoplasms
    2. Lymphoma
    3. Hematologic Neoplasms
    4. Coronavirus Disease
    Interventions
    1. Drug: TAK-981
    2. Drug: Standard of care
    MeSH:Coronavirus Infections Neoplasms Hematologic Neoplasms
    HPO:Hematological neoplasm Leukemia Neoplasm

    Primary Outcomes

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs)

    Time: Up to 36 months

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Dose Limiting Toxicities (DLTs)

    Time: Up to 36 months

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With one or More Serious Adverse Events (SAEs)

    Time: Up to 36 months

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations

    Time: Up to 36 months

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Greater Than or Equal to (>=) Grade 3 TEAEs

    Time: Up to 36 months

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Clinically Significant Laboratory Values

    Time: Up to 36 months

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Clinically Significant Vital Sign Measurements

    Time: Up to 36 months

    Description: CRS will be graded as per American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for CRS.

    Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants who Experience Cytokine Release Syndrome CRS)

    Time: Up to 36 months

    Measure: COVID-19 Expansion: Number of Participants With >=2 log Reduction From Baseline in Viral Load or Below Level of Detection (Negative) in Nasopharyngeal or Oropharyngeal Samples

    Time: Up to 9 months

    Secondary Outcomes

    Measure: Dose Escalation and Cancer Treatment Expansions, Cmax: Maximum Observed Plasma Concentration for TAK-981

    Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length is equal to [=] 21 days)

    Measure: Dose Escalation and Cancer Treatment Expansions, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-981

    Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

    Measure: Dose Escalation and Cancer Treatment Expansions, AUCt: Area Under the Plasma Concentration-time Curve from Time 0 to Time t Over the Dosing Interval for TAK-981

    Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

    Measure: Dose Escalation and Cancer Treatment Expansions, AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-981

    Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

    Measure: Dose Escalation and Cancer Treatment Expansions, Terminal Disposition Phase Half-life (t1/2z) for TAK-981

    Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

    Measure: Dose Escalation and Cancer Treatment Expansions, Total Clearance After Intravenous Administration (CL) for TAK-981

    Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

    Measure: Dose Escalation and Cancer Treatment Expansions, Volume of Distribution at Steady State After Intravenous Administration (Vss) for TAK-981

    Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

    Description: ORR is defined as percentage of participants who achieve complete response (CR) and partial response (PR) through the study (approximately 3 years), as determined by the investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) for participants with solid tumors and Response Evaluation Criteria in Lymphoma (RECIL) for participants with lymphoma.

    Measure: Dose Escalation and Cancer Treatment Expansions: Overall Response Rate (ORR)

    Time: From the first dose until best response is achieved (up to approximately 3 years)

    Description: DOR will be determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.

    Measure: Dose Escalation and Cancer Treatment Expansions: Duration of Response (DOR)

    Time: From the time of documentation of tumor response to the first recorded occurrence of disease progression (PD) or death from any cause (whichever occurs first), through end of study (up to approximately 3 years)

    Description: DCR is defined as percentage of participants who achieve stable disease (SD) or better greater than (>) 6 weeks during the study in response-evaluable population, as determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.

    Measure: Dose Escalation and Cancer Treatment Expansions: Disease Control Rate (DCR)

    Time: From the first dose until best response is achieved (up to approximately 3 years)

    Description: PFS will be determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.

    Measure: Dose Escalation and Cancer Treatment Expansions: Progression-free Survival (PFS)

    Time: From the date of the first dose administration to the date of first documentation of PD or death due to any cause whichever occurs first, through the end of the study (up to approximately 3 years)

    Description: TTR will be determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.

    Measure: Dose Escalation and Cancer Treatment Expansions: Time to Response (TTR)

    Time: From the date of first study drug administration to the date of first documented PR or better (up to approximately 3 years)

    Measure: Dose Escalation and Cancer Treatment Expansions: Percentage of Participants at Each Dose Level Demonstrating Adduct Formation in Post-dose Skin or Tumor Biopsies

    Time: Up to Cycle 1 (approximately 3 weeks) (Cycle length =21 days)

    Measure: Dose Escalation and Cancer Treatment Expansions: Percent Change in Small Ubiquitin-like Modifier (SUMO) 2/3 Signal With Pre and Post-dose Skin or Tumor Biopsies at Each Dose Level

    Time: Up to Cycle 1 (approximately 3 weeks) (Cycle length =21 days)

    Measure: COVID-19 Expansion: Number of Participants Reporting one or More TEAEs

    Time: Up to 9 months

    Description: Severity Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 5.0.

    Measure: COVID-19 Expansion: Number of Participants Based on Severity of TEAEs

    Time: Up to 9 months

    Measure: COVID-19 Expansion: Number of Participants Based on Duration of TEAEs

    Time: Up to 9 months

    Description: CRS will be graded as per ASTCT Consensus Grading for CRS.

    Measure: COVID-19 Expansion: Number of Participants who Experience CRS

    Time: Up to 9 months

    Description: NEWS determines the degree of illness of participants and prompts critical care intervention. It will be based on the score allocated to respiratory rate, peripheral capillary oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness.

    Measure: COVID-19 Expansion: Change from Baseline in National Early Warning Score (NEWS)

    Time: Up to 9 months

    Description: Percentage of participants will be reported based on severity rating on a 6-point ordinal scale, which will include: 1 (death); 2 (hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation, hospitalized); 3 (on non-invasive ventilation or high flow oxygen devices); 4 (hospitalized, requiring supplemental oxygen); 5 (hospitalized, not requiring supplemental oxygen); and 6 (not hospitalized).

    Measure: COVID-19 Expansion: Percentage of Participants Reporting Each Hospitalization Severity Rating

    Time: Up to 9 months

    Description: Change from Baseline in SARS-CoV-2 viral Load in nasopharyngeal or oropharyngeal samples will be determined by viral response. The nasopharyngeal swab will be collected from both nostrils or from the same nostril every time.

    Measure: COVID-19 Expansion: Change From Baseline in SARS-CoV-2 Viral Load in Nasopharyngeal or Oropharyngeal Samples

    Time: Up to 9 months

    Measure: COVID-19 Expansion: Percentage of Participants Requiring Oxygen Supplementation; Assisted or Positive Pressure Non-invasive Ventilation; and Invasive Ventilation, on Days 3, 5, 8, 11, 15, and 30

    Time: Days 3, 5, 8, 11, 15, and 30

    Measure: COVID-19 Expansion: Percentage of Participants That met Intensive Care Unit (ICU) Criteria

    Time: Up to 9 months

    Measure: COVID-19 Expansion: Duration of Hospitalization

    Time: Up to 9 months

    Description: Time from the first dose of TAK-981 to viral load negativity (below level of detection).

    Measure: COVID-19 Expansion: Time to Viral Ribonucleic Acid (RNA) Negativity in Nasopharyngeal or Oropharyngeal Samples

    Time: Up to 9 months

    Description: Time from first dose of TAK-981 to participant's discharge or to NEWS score <=3. NEWS determines the degree of illness of participants and prompts critical care intervention. It will be based on the score allocated to respiratory rate, peripheral capillary oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness.

    Measure: COVID-19 Expansion: Time to Discharge or to a NEWS of Less Than or Equal to (<=) 3 and Maintained for 24 Hours

    Time: Up to 9 months

    Measure: COVID-19 Expansion: Number of Deaths in Hospital due to any Cause in First 30 Days and in 90 Days

    Time: Days 30 and 90
    6 A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06939999 (PRMT5 INHIBITOR) IN PARTICIPANTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER, HEAD AND NECK SQUAMOUS CELL CARCINOMA, ESOPHAGEAL CANCER, ENDOMETRIAL CANCER, CERVICAL CANCER AND BLADDER CANCER

    This is a Phase 1, open label, multi center, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients with advanced or metastatic cancer.

    NCT03854227
    Conditions
    1. Advanced Solid Tumors
    2. Metastatic Solid Tumors
    Interventions
    1. Drug: PF-06939999 dose escalation
    2. Drug: PF-06939999 monotherapy
    3. Drug: PF-06939999 in combination with docetaxel
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: DLTs will be evaluated during the first cycle. The number of DLTs will be used to determine the maximum tolerated dose (MTD)

    Measure: Number of participants with dose limiting toxicities (DLTs)

    Time: Baseline through day 28

    Description: Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy

    Measure: Number of participants with treatment emergent adverse events (AEs)

    Time: Baseline through up to 2 years or until disease progression

    Description: Laboratory abnormalities as characterized by type, frequency, severity, and timing.

    Measure: Number of participants with laboratory abnormalities

    Time: Baseline through up to 2 years or until disease progression

    Description: Best Overall Response by RECIST 1.1

    Measure: Objective Response Rate

    Time: Baseline through up to 2 years or until disease progression

    Secondary Outcomes

    Description: Single dose PK will be calculated including Maximum Observed Plasma Concentration (Cmax).

    Measure: Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)

    Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24

    Description: Single dose PK will be calculated including Time to reach Maximum Observed Plasma Concentration (Tmax).

    Measure: Pharmacokinetic Parameters: Time to reach Maximum Observed Plasma Concentration (Tmax)

    Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24

    Description: Single dose PK will be calculated including Area Under the Curve from time 0 to the last sampling time point within the dose interval (AUClast)

    Measure: Pharmacokinetic Parameters: Area Under the Curve from time 0 to the last sampling time point within the dose interval (AUClast)

    Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24

    Description: Single dose PK will be calculated including, as data permit, terminal elimination half life (t1/2)

    Measure: Pharmacokinetic Parameters: Terminal elimination half life (t1/2)

    Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24

    Description: Single dose PK will be calculated including, as data permit, Area Under the Curve from time 0 extrapolated to infinity (AUCinf)

    Measure: Pharmacokinetic Parameters: AUC from time 0 extrapolated to infinity (AUCinf)

    Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24

    Description: Single dose PK will be calculated including, as data permit, apparent oral plasma clearance (CL/F)

    Measure: Pharmacokinetic Parameters: Apparent oral plasma clearance (CL/F)

    Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24

    Description: Single dose PK will be calculated including, as data permit, apparent volume of distribution (Vz/F)

    Measure: Pharmacokinetic Parameters: Apparent volume of distribution (Vz/F)

    Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24

    Description: Multiple dose PK will be calculated including Maximum Observed Steady State Plasma Concentration (Css,max).

    Measure: Pharmacokinetic Parameters: Maximum Observed Steady State Plasma Concentration (Css,max)

    Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24

    Description: Multiple dose PK will be calculated including Time to reach Maximum Observed Steady State Plasma Concentration (Tss,max).

    Measure: Pharmacokinetic Parameters: Time to reach Maximum Observed Steady State Plasma Concentration (Tss,max)

    Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24

    Description: Multiple dose PK will be calculated including Area Under the Curve within one dose interval (AUCss,t)

    Measure: Pharmacokinetic Parameters: Area Under the Curve within one dose interval (AUCss,t)

    Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24

    Description: Multiple dose PK will be calculated including, as data permit, steady state apparent oral plasma clearance (CL/F)

    Measure: Pharmacokinetic Parameters: Steady state apparent oral plasma clearance (CL/F)

    Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8. 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24

    Description: Multiple dose PK will be calculated including, as data permit, steady state apparent volume of distribution (Vss/F)

    Measure: Pharmacokinetic Parameters: Steady state apparent volume of distribution (Vss/F)

    Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24

    Description: Multiple dose PK will be calculated including, as data permit, accumulation ratio (Rac)

    Measure: Pharmacokinetic Parameters: Accumulation ratio (Rac)

    Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24

    Description: DOR as assessed using RECIST 1.1

    Measure: Duration of response (DOR)

    Time: Baseline through up to 2 years or until disease progression

    Description: PFS as assessed using RECIST 1.1.

    Measure: Progression free survival (PFS)

    Time: Baseline through up to 2 years or until disease progression

    Description: TTP as assessed using RECIST 1.1.

    Measure: Time to progression (TTP)

    Time: Baseline through up to 2 years or until disease progression

    Description: Proportion of participants alive at 6 months, 1 year and 2 years.

    Measure: Overall Survival (OS)

    Time: Baseline through up to 2 years
    7 Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors

    Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.

    NCT03915678
    Conditions
    1. Solid Tumor, Adult
    2. Pancreatic Cancer
    3. Virus-associated Tumors
    4. Non Small Cell Lung Cancer
    5. Melanoma
    6. Bladder Cancer
    7. Triple Negative Breast Cancer
    Interventions
    1. Drug: Association atezolizumab + BDB001 + RT
    2. Drug: Association atezolizumab + BDB001+ RT
    3. Drug: Association atezolizumab + BDB001+ RT
    4. Drug: Association atezolizumab + BDB001 + RT
    5. Drug: Association atezolizumab + BDB001 + RT
    6. Drug: Association atezolizumab + BDB001 + RT
    MeSH:Neoplasms Triple Negative Breast Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.

    Measure: Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with pancreatic cancer.

    Time: Within 6 months of treatment onset

    Description: Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.

    Measure: Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with virus associated tumors.

    Time: Within 6 months of treatment onset

    Description: Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.

    Measure: Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with non-small cell lung cancer.

    Time: Within 6 months of treatment onset

    Description: Antitumor activity will be assessed in terms of 6-month progression-free rat (PFR) and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed at 6 months following treatment onset and more than 24 weeks, based on RECIST 1.1 criteria.

    Measure: Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with soft-tissue sarcoma.

    Time: 6 months of treatment onset

    Description: Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.

    Measure: Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with bladder cancer.

    Time: Within 6 months of treatment onset

    Description: Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.

    Measure: Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with triple negative breast cancer.

    Time: Within 6 months of treatment onset

    Secondary Outcomes

    Description: Progression-free rate is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST 1.1 criteria.

    Measure: 6-month Progression-free rate (PFR) in patients with pancreatic cancer.

    Time: 6 months

    Description: Progression-free rate is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST 1.1 criteria.

    Measure: 6-month Progression-free rate (PFR) in patients with virus-associated tumor.

    Time: 6 months

    Description: Progression-free rate is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST 1.1 criteria.

    Measure: 6-month Progression-free rate (PFR) in patients with non-small cell lung cancer.

    Time: 6 months

    Description: Progression-free rate is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST 1.1 criteria.

    Measure: 6-month Progression-free rate (PFR) in patients with bladder cancer.

    Time: 6 months

    Description: Progression-free rate is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST 1.1 criteria.

    Measure: 6-month Progression-free rate (PFR) in patients with triple negative breast cancer.

    Time: 6 months

    Description: Objective response is defined as the proportion of patients with complete response (CR) or partial response (PR) observed at 6 months, based on RECIST 1.1 criteria.

    Measure: 6-month objective response rate (ORR) independently for each population.

    Time: 6 months

    Description: Objective response is defined as the proportion of patients with complete response (CR) or partial response (PR) observed within 24 wekks after treatment onset, based on RECIST 1.1 criteria.

    Measure: Objective response rate (ORR) within 24 weeks of treatment onset, independently for each population.

    Time: Within 6 months

    Description: Best overall response is defined as the best response across all time points (RECIST 1.1). The best overall response is determined once all the data for the patient is known (RECIST 1.1).

    Measure: Best overall response, independently for each population.

    Time: Throughout the treatment period, an expected average of 6 months

    Description: Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first.

    Measure: 1-year progression-free survival, independently for each population.

    Time: 1 year

    Description: Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first.

    Measure: 2-year progression-free survival, independently for each population.

    Time: 2 years

    Description: Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).

    Measure: 1-year overall survival, independently for each population.

    Time: 1 year

    Description: Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).

    Measure: 2-year overall survival, independently for each population.

    Time: 2 years

    Description: Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.

    Measure: Safety profile, independently for each population: Common Terminology Criteria for Adverse Events version 5

    Time: Throughout the treatment period, an expected average of 6 months

    Description: Levels of immune cells in tumor will be measured by immunohistochemistry.

    Measure: Tumor immune cells levels

    Time: before treatment onset and cycle 3 day 1 (each cycle is 21 days)

    Description: Levels of cytokines in blood will be measured by ELISA.

    Measure: Blood cytokines levels

    Time: baseline, cycle 1 day 1, cycle 2 day 1, cycle 3 day 1 and progression (each cycle is 21 days)

    Description: Levels of lymphocytes in blood will be measured by flow cytometry.

    Measure: Blood lymphocytes levels

    Time: baseline, cycle 1 day 1, cycle 2 day 1, cycle 3 day 1 and progression (each cycle is 21 days)

    Description: Levels of kynurenine in blood will be measured by ELISA.

    Measure: Blood kynurenine levels

    Time: baseline, cycle 1 day 1, cycle 2 day 1, cycle 3 day 1 and progression (each cycle is 21 days)
    8 Adaptation and Pilot Feasibility of a Psychotherapy Intervention for Latinos With Advanced Cancer

    The purpose of this study is to adapt a counseling intervention called Meaning Centered Psychotherapy to make it culturally relevant for Latinos. Cancer affects patients and their loved ones. Latinos often experience greater challenges due to the cancer. However, few studies and interventions focus on Latinos. We are interested in understanding what affects Latino patients' quality of life, and how to improve it

    NCT04015609
    Conditions
    1. Solid Tumor
    2. Solid Tumor, Adult
    3. Solid Tumor, Unspecified, Adult
    Interventions
    1. Behavioral: Meaning Centered Psychotherapy for Latinos
    2. Behavioral: Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale
    3. Behavioral: Meaning Centered Psychotherapy for Latinos for Waitlist Control Patients
    4. Behavioral: Pre-assessment questionnaire
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: FACIT Spiritual Well-Being Scale is a brief self-report measure designed to assess the nature and extent of individual spiritual well-being. This measure, which generates two sub-scales, one corresponding to Faith (the importance of faith and spirituality) and a second assessing Meaning-Peace (one sense of meaning and purpose in life), has been demonstrated to have strong internal reliability for both the total score as well as each subscale (coefficient alpha equals .87 for the total scale, .88 for the faith factor and .81 for the meaning factor). In additional, strong support for the external validity of this measure has been demonstrated in a several large samples of cancer and AIDS patients and with Spanish speaking populations.

    Measure: Spiritual Well-Being measured with the FACIT Spiritual Well-Being Scale

    Time: Change from baseline to post assessment 7-14 weeks after

    Secondary Outcomes

    Description: The Hospital Anxiety and Depression Scale (HADS) is a validated scale used to measure anxiety and depression. This scale has been validated against structured or semi-structured clinical interviews, the gold standard for the assessment of mental disorders, in a significant number of studies. Further strengths of this scale for the assessment of emotional distress in cancer patients stem from the joint assessment of anxiety and depressive symptoms without referring to physical symptoms of anxiety or depression. Given the high comorbidity of anxiety of cancer as well as the systematic exclusion of confounding physical symptoms, the scale seems especially appropriate for use in this patient group. The HADS consists of 14 items which reflect a 7-item anxiety and a 7-item depression subscale. This scale has sound psychometric properties in Spanish.

    Measure: Depression and Anxiety measured with the Hospital Anxiety and Depression Scale

    Time: Change from baseline to post assessment 7-14 weeks after

    Description: The Beck Hopelessness Scale (BHS) comprises 20 true/false questions that assess degree of pessimism and hopelessness. Several studies have demonstrated a high degree of internal consistency and construct validity. Scores ranging from 4 to 8 typically indicate a "mild" degree of hopelessness, 9 to 12 correspond to "moderate" hopelessness, and scores about 12 reflect "severe" levels of hopelessness.

    Measure: Hopelessness measured with the Beck Hopelessness Scale

    Time: Change from baseline to post assessment 7-14 weeks after

    Description: The FACIT Spiritual Well-Being Scale (FACIT-Sp-12) is a brief self-report measure designed to assess the nature and extent of individual's spiritual well-being. This measure (range 0-48), which generates two sub-scales, Faith (the importance of faith/spirituality, range 0-16) and Meaning /Peace (one's sense of meaning and purpose in life, range 0-32). The total score for the FACIT-Sp scale is the sum of the two subscales Faith and Meaning /Peace. It has been demonstrated to have strong internal reliability for both the total score as well as each subscale (coefficient alpha = .87 for the total scale, .88 for the faith factor and .81 for the meaning factor). Higher scores represent a higher level of spiritual well-being, faith or meaning-peace. In addition, strong support for the external validity of this measure has been demonstrated in a several large samples of cancer and AIDS patients and with Spanish speaking populations. Administration time takes approximately 4 minutes.

    Measure: Quality of life measured with the FACIT Spiritual Well-Being Scale

    Time: Change from baseline to post assessment 7-14 weeks after
    9 Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness

    The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients over the age of 65 with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1) to evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion during the hospitalization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 30-day hospital readmissions; and 2) to conduct a mixed-methods evaluation of the implementation of the Jumpstart intervention, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative assessments of effectiveness, implementation and maintenance and qualitative assessments of clinician perspectives on barriers and facilitators to future implementation and dissemination.

    NCT04281784
    Conditions
    1. Dementia
    2. Chronic Disease
    3. Neoplasm Metastasis
    4. Lung Neoplasm
    5. Pulmonary Disease, Chronic Obstructive
    6. Heart Failure,Congestive
    7. Liver Cirrhosis
    8. Kidney Failure, Chronic
    9. Lung Diseases, Interstitial
    10. Peripheral Vascular Disease
    11. Diabetes With End Organ Injury
    12. Palliative Care, Patient Care
    13. Health Care Quality, Access, and Evaluation
    14. Patient Care
    15. Inpatients
    16. Health Communication
    17. Patient Care Planning
    Interventions
    1. Behavioral: EHR-based Clinician Jumpstart
    MeSH:Neoplasms Neoplasm Metastasis Lung Neoplasms Liver Cirrhosis Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Interstitial Renal Insufficiency Kidney Failure, Chronic Heart Failure Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Chronic Disease
    HPO:Abnormal left ventricular function Abnormal lung morphology Chronic pulmonary obstruction Cirrhosis Congestive heart failure Hepatic fibrosis Interstitial pneumonitis Interstitial pulmonary abnormality Neoplasm Neoplasm of the lung Peripheral arterial stenosis Renal insufficiency Right ventricular failure

    Primary Outcomes

    Description: The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. Study staff will manually review and compare findings using a randomly-selected sample of charts using our standard EHR abstraction methods; manual chart abstraction will be the gold standard.

    Measure: EHR documentation of Goals of Care discussions

    Time: Assessed for the period between randomization and 30 days following randomization

    Secondary Outcomes

    Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR using our automated and validated methods.

    Measure: Intensity of care/ICU use: ICU admissions

    Time: Assessed for the period between randomization and 30 days following randomization

    Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the ICU during their (index) hospital stay will be collected from the EHR using our automated and validated methods.

    Measure: Intensity of care/ICU use: ICU length of stay

    Time: Assessed for the period between randomization and 30 days following randomization

    Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the hospital during that (index) hospital stay will be collected from the EHR using our automated and validated methods.

    Measure: Intensity of care/Hospital use: Hospital length of stay

    Time: Assessed for the period between randomization and 30 days following randomization

    Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.

    Measure: Intensity of care: Hospital Readmissions 30 days

    Time: Assessed for the period between randomization and 30 days following randomization

    Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.

    Measure: Intensity of care: ICU Readmissions 30 days

    Time: Assessed for the period between randomization and 30 days following randomization

    Description: Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.

    Measure: Intensity of care: Healthcare costs

    Time: 1 and 3 months after randomization

    Description: From Washington State death certificates.

    Measure: All-cause mortality at 1 year (safety outcome)

    Time: 1 year after randomization

    Other Outcomes

    Description: Qualitative interviews after individual participation. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context.

    Measure: Key Implementation Factors

    Time: 3 months after randomization
    10 The Safety of Chemotherapy for Patients With Gynecological Malignancy in High-risk Region of COVID-19, a Prospective Cohort Study

    A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19) emerged at December 2019 in Wuhan, China, and soon caused a large global outbreak. The delayed treatment for many chronic diseases, due to the concern of SARS-CoV-2 infection, is an increasing serious problem. Here the investigators investigate the safety of chemotherapy for patients with gynecological malignancy in Wuhan, the center of high-risk regions of COVID-19.

    NCT04341480
    Conditions
    1. Gynecological Cancer
    Interventions
    1. Drug: Chemotherapy
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: Incidence rate of SARS-CoV-2 infection within the whole period of the study.

    Measure: SARS-CoV-2 infection

    Time: through study completion, an average of 3 months.

    Secondary Outcomes

    Description: Tumor response by determining changes (PD, SD, PR, CR) according to Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1

    Measure: Tumor response

    Time: 6 weeks after enrollment.

    Description: Safety and tolerability of chemotherapy as measured by the Common Terminology Criteria for Adverse Events (version 4.0)

    Measure: Safety and tolerability of chemotherapy as measured by the Common Terminology

    Time: through study completion, an average of 3 months.

    Description: To evaluate quality of life (QOL) for the subjects undergoing this treatment, using validated tools. QOL will be assessed every 3 months during treatment course. [Functional Assessment of Cancer Therapy - Ovarian Cancer questionnaire (score range from 0 to 160. Higher scores represent better quality of life. questionnaire core-30 (QLQ-C30).

    Measure: Quality of Life (QOL) measures using Functional Assessment of Cancer Therapy (FACT- ovarian cancer)

    Time: through study completion, an average of 3 months.
    11 Impact of the COVID-19 Pandemic on Changes in Therapeutic Strategies in Gynecological Oncology

    The current infection with the Coronavirus SARS-CoV-2 (COVID-19) is an exceptional health situation which requires an adaptation of our management practices in gynecological oncology. Data from the literature suggest that infection with Coronavirus is serious in subjects with cancer with a risk of severe form 5 times higher than that of the population without cancer and a risk of death multiplied by 8. In addition, the risk of infection would be 3 times greater in case of cancer. Faced with the COVID-19 epidemic, the investigator must organize themselves to ensure continuity in the treatment of patients with gynecological cancer but also adapt our practices in the management (CPR, teleconsultation, adaptation of treatment or even postponement of treatment). The objective of the High Council of Public Health is to be able to ensure adequate oncological care avoiding any potential loss of chance concerning the care of cancer: people affected must, despite the pandemic, have care allowing the same level of curability (localized cancers) or the same life expectancy (advanced cancers). This must be done by limiting as much as possible the impact on the organization of the service, the organization of patient follow-up and the psychological impact that these possible modifications could have. The hypotheses of our study are that the exceptional health situation linked to this pandemic leads to a change in the care of patients with gynecological cancer associated with a psychological impact and increased anxiety of patients during their care. Despite the extent of the pandemic, very little existing data makes it possible to define recommendations with a sufficient level of evidence.

    NCT04351139
    Conditions
    1. Gynecologic Cancer
    2. Breast Neoplasm Female
    3. Uterine Neoplasms
    4. Ovarian Neoplasms
    5. Uterine Cervical Neoplasms
    6. Vulvar Neoplasms
    7. Vaginal Neoplasms
    Interventions
    1. Other: modification of the planned therapeutic management
    MeSH:Neoplasms Breast Neoplasms Ovarian Neoplasms Uterine Cervical Neoplasms Uterine Neoplasms Vulvar Neoplasms Vaginal Neoplasms
    HPO:Breast carcinoma Cervical polyp Cervix cancer Neoplasm Neoplasm of the breast Ovarian neoplasm Uterine neoplasm Vaginal neoplasm Vulvar neoplasm

    Primary Outcomes

    Description: modification of the planned therapeutic management

    Measure: percentage of patients with a change in the planned therapeutic management (surgery, chemotherapy, radiotherapy, hormone therapy)

    Time: Day O
    12 SARS-CoV-2 Infection in Patients With Hematological Malignancies: the Italian Hematology Alliance

    This is a retrospective/prospective, cohort, non-interventional observational study. This means that all patients with documented COVID and HM diagnosed between February 2020 and study initiation will compose the retrospective part, while those diagnosed after study approval will enter prospective part. The total duration of the study will be 12 months. The study population will must be older than 18 years of age with HM and SARS-CoV-2 infection. All patients with documented SARS-CoV-2 infection (COVID) and history or active hematological malignancies, who refer to any Hematological Unit will be included.

    NCT04352556
    Conditions
    1. SARS-CoV-2 Infection
    2. Hematological Malignancies
    MeSH:Infection Neoplasms Hematologic Neoplasms
    HPO:Hematological neoplasm Leukemia Neoplasm

    Primary Outcomes

    Description: The percentage of HM patients with COVID-19 who died.

    Measure: To evaluate mortality.

    Time: At 2 months from study initiation

    Description: We will assess the correlation between some biochemical parameters at diagnosis of COVID (i.e. hemoglobin, platelets, lymphocytes, clotting tests, CRP), each on the basis of its specific unit of measure, and mortality.

    Measure: To evaluate potential predictive biochemical parameters of mortality.

    Time: At 2 months from study initiation

    Description: We will assess the correlation between HM-related parameters at diagnosis of COVID [i.e. disease type (leukemia, lymphomas, myeloma), disease status (remission / stable / progression), therapy status (on / off therapy)] and mortality.

    Measure: To evaluate potential predictive HM-related parameters of mortality.

    Time: At 2 months from study initiation

    Description: We will assess the correlation between COVID severity [mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 < 300 and/or lung infiltrates > 50%) and critical (respiratory failure, septic shock, and/or multiple organ disfunction or failure)] and mortality

    Measure: To evaluate COVID severity as predictive parameter of mortality.

    Time: At 2 months from study initiation

    Secondary Outcomes

    Description: Description of the different types of hematological malignancies (WHO criteria) in patients with SARS-CoV-2 infection. All aggregated data will be stratified on the basis of COVID severity: mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 < 300 and/or lung infiltrates > 50%) and critical disease (respiratory failure, septic shock, and/or multiple organ disfunction or failure)

    Measure: Epidemiology of patients with HM infected by SARS-CoV-2with any spectrum of illness severity

    Time: At 6 months from study initiation

    Description: Characterization of clinical and biochemical profile of patients with SARS-CoV-2 positivity.

    Measure: Definition of complete clinical picture of COVID-19 in HM

    Time: At 2 months from study initiation

    Description: Assessment of HM status post SARS-CoV-2 infection stratified as no implication, loss of response, progression of the hematological disease.

    Measure: Evolution of HM

    Time: At 2 months from study initiation

    Description: Percentage of HM patients being admitted to ICU requiring mechanical ventilation, or death stratified per disease type, status, per off-therapy/on-therapy, per type of therapy (chemo, immunotherapy, cell therapy, stem cell transplant).

    Measure: To evaluate admission to ICU requiring mechanical ventilation or death per characteristics

    Time: At 2 months from study initiation

    Measure: Viral dynamics in infected HM patients

    Time: At 12 months from study initiation
    13 The COVID-19 and Cancer Consortium (CCC19) Registry

    In this study we will collect granular information on cancer patients infected with COVID-19, as rapidly as possible. The mechanism for collection of this information is a de-identified centralized registry housed at Vanderbilt University Medical Center, with data donations from internal and external health care professionals.

    NCT04354701
    Conditions
    1. COVID-19
    2. Invasive Malignancy (Any Type)
    Interventions
    1. Other: Web-based REDCap survey
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: The survey includes five parts: 1) basic demographics about the patient, including performance status and comorbidities; 2) initial COVID-19 diagnosis and clinical course; 3) cancer and cancer treatment details; 4) respondent details; 5) long-term COVID-19 outcomes.

    Measure: Web-based REDCap survey

    Time: Approximately 18 months
    14 Tociluzumab for Cytokine Release Syndrome With SARS-CoV-2: An Open-Labeled, Randomized Phase 3 Trial

    This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.

    NCT04361552
    Conditions
    1. Cerebrovascular Accident
    2. Chronic Obstructive Pulmonary Disease
    3. Chronic Renal Failure
    4. Coronary Artery Disease
    5. Diabetes Mellitus
    6. Malignant Neoplasm
    7. SARS Coronavirus 2 Infection
    Interventions
    1. Other: Best Practice
    2. Biological: Tocilizumab
    MeSH:Infection Neoplasms Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Stroke Kidney Failure, Chronic Coronary Artery Disease
    HPO:Chronic pulmonary obstruction Coronary artery atherosclerosis Neoplasm Pulmonary obstruction Stroke

    Primary Outcomes

    Description: The 7-day length of invasive MV for each arm will be estimated with 95% confidence intervals (CIs) using the exact binomial distribution. Their difference by the arms will be tested by Cochran-Mantel-Haenszel (CMH) test stratified by the age group and Sequential Organ Failure Assessment (SOFA) score at significance level of 0.05.

    Measure: 7-day length of invasive mechanical ventilation (MV)

    Time: Up to 7 days

    Description: Defined as death within 30-day after randomization. The 30-day mortality rate for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

    Measure: 30-day mortality rate

    Time: Up to 30-day after randomization

    Secondary Outcomes

    Description: The rate of ICU transfer for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

    Measure: Rate of intensive care (ICU) transfer

    Time: Up to 2 years

    Description: The rate of invasive mechanical ventilation for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

    Measure: Rate of invasive mechanical ventilation

    Time: Up to 2 years

    Description: The rate of tracheostomy for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

    Measure: Rate of tracheostomy

    Time: Up to 2 years

    Description: Will first be described by median and inter-quartile, and then compared between two arms by Wilcoxon Sum-Rank test

    Measure: Length of ICU stay

    Time: Up to 2 years

    Measure: Length of hospital stay

    Time: Up 2 years
    15 COVID-19 Serodiagnosis in Oncology

    EVIDENCE is a non interventional, French, multicenter study. Patients will be screened by local severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoassay in their oncology department (rapid diagnostic test (RDT) or enzyme-linked immunosorbent assay (ELISA)). In patients with positive local SARS-CoV-2 immunoassay, a centralized SARS-CoV-2 ELISA will be performed in order to double check the immune response of all patients considered immune by local immunoassay.

    NCT04367870
    Conditions
    1. Oncology
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: The primary endpoint of this study is the recurrence of COVID-19 within 3 months following the immunoassay-positive result obtained before the inclusion in the study. The recurrence is defined by the presence of symptoms confirmed either by a positive reverse transcription-polymerase chain reaction (RT-PCR) result for SARS-CoV-2 or by the adjudication committee. Immunoassay will be said positive as per the predefined reference corresponding to the immunoassay.

    Measure: To evaluate the ability of SARS-CoV-2 immunoassays, following a positive result, to identify patients with very low risk of recurrence of COVID-19 within 3 months.

    Time: 3 months

    Secondary Outcomes

    Description: The prevalence is the ratio between the number of immunoassay-positive patients and the number of patients tested over a predefined period, i.e the whole duration of the study and by 1-month intervals.

    Measure: To estimate the prevalence of patients immunized to the SARS-CoV-2 virus in an oncology population over the whole study duration and within one-month periods.

    Time: 6 months

    Description: Agreement between the different immunoassays and the centralized ELISA, using the centralized ELISA as benchmark.

    Measure: To estimate the discordance rate between local immunoassay and a centralized ELISA in patients with a positive immunoassay, whatever the immunoassay.

    Time: 6 months

    Description: COVID-19 recurrence within 6 months following an immunoassay-positive result.

    Measure: To identify patients with very low risk of recurrence of COVID-19 within 6 months following a positive immunoassay result.

    Time: 6 months

    Description: Quantitative and qualitative detection of SARS-CoV-2-related antibodies and immune serum markers at baseline, 2-3 months and 4-6 months post-inclusion, in a subgroup of 200 patients.

    Measure: To characterize the evolution over time of the serologic response against SARS-CoV-2 (in a subgroup of patients).

    Time: 6 months
    16 A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of T3011 in Advanced Cutaneous or Subcutaneous Malignancies

    A phase 1, open-label, first-in-human study of T3011 monotherapy to evaluate the safety and tolerability of T3011 in patients with advanced cancers with cutaneous or subcutaneous tumor deposits who have progressed while receiving standard of care therapy or who will not benefit from such therapy.

    NCT04370587
    Conditions
    1. Head and Neck Cancer
    2. Soft Tissue Tumor and/or Sarcoma
    3. Neoplasm of Skin
    4. Neoplasm Metastasis
    5. Melanoma
    6. Lung Cancer
    7. Solid Tumor
    Interventions
    1. Biological: T3011
    2. Biological: T3011
    MeSH:Neoplasms Neoplasm Metastasis Soft Tissue Neoplasms Skin Neoplasms
    HPO:Neoplasm Neoplasm of the skin

    Primary Outcomes

    Description: Number of participants in dose escalating arm with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.

    Measure: Safety and tolerability of T3011 in dose escalating administration in patients with advanced cutaneous or subcutaneous malignancies

    Time: From first dose of T3011 (Week 1 Day 1) until 60 days after the last T3011 injection (up to 2 years)

    Description: Number of participants in dose expansion arm with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.

    Measure: Safety and tolerability of T3011 in dose expansion administration in patients with advanced cutaneous or subcutaneous malignancies

    Time: From first dose of T3011 (Week 1 Day 1) until 60 days after the last T3011 injection (up to 2 years)

    Secondary Outcomes

    Description: To evaluate the virus shedding following intratumoral injection

    Measure: Presence and frequency of T3011 in serum, saliva, urine, and injection site/dressing

    Time: Up to 24 months

    Description: To evaluate IL-12 and anti-PD-1 antibody expression of T3011 post intervention.

    Measure: Quantitative measurements of serum IL-12 and anti-PD-1 antibody concentration.

    Time: Up to 24 months

    Description: To evaluate the immunogenicity of anti-PD-1 antibody expressed by T3011 post intervention.

    Measure: Presence of neutralizing antibodies of anti-PD-1 antibody for antidrug antibodies (ADAs) development

    Time: Up to 24 months

    Description: To evaluate the immunogenicity of T3011 viral vector post intervention.

    Measure: Presence of anti-herpes simplex virus type 1 (HSV-1) antibody compared to baseline

    Time: Up to 24 months

    Description: ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measure: Overall response rate (ORR)

    Time: Up to 24 months

    Description: DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments per RECIST 1.1.

    Measure: Disease control rate (DCR)

    Time: Up to 24 months

    Description: DOR is defined as the time from the first met CR or PR until disease progression or death due to any cause, whichever occurs first.

    Measure: Duration of response (DOR).

    Time: Up to 24 months

    Description: DR is defined as objective response (CR or PR) according to RECIST 1.1, with a duration of at least 6 months.

    Measure: Durable response (DR)

    Time: Up to 24 months

    Description: To evaluate the progression free survival (PFS) and overall survival (OS) of participants.

    Measure: Survival (assessment per RECIST 1.1 and immune-modified RECIST (imRECIST)).

    Time: Up to 24 months
    17 Tocilizumab in Hospitalized Cancer Patients With Coronavirus 2019 (SARS-CoV-2) and Severe Complications of Coronavirus Disease 19 (COVID-19)

    This phase II expanded access trial will study how well tocilizumab works in reducing the serious symptoms including pneumonitis (severe acute respiratory distress) in patients with cancer and COVID-19. COVID-19 is caused by the SARS-CoV-2 virus. COVID-19 can be associated with an inflammatory response by the immune system which may also cause symptoms of COVID-19 to worsen. This inflammation may be called "cytokine storm," which can cause widespread problems in the body. Tocilizumab is a medicine designed to block the action of a protein called interleukin-6 (IL-6) that is involved with the immune system and is known to be a key factor for problems with excessive inflammation. Tocilizumab is effective in treating "cytokine storm" from a type of cancer immunotherapy and may be effective in reducing the inflammatory response and "cytokine storm" seen in severe COVID-19 disease. Treating the inflammation may help to reduce symptoms, improve the ability to breathe without a breathing machine (ventilator), and prevent patients from having more complications.

    NCT04370834
    Conditions
    1. Hematopoietic and Lymphoid Cell Neoplasm
    2. Malignant Solid Neoplasm
    3. Pneumonia
    4. Pneumonitis
    5. Severe Acute Respiratory Distress Syndrome
    6. Symptomatic COVID-19 Infection Laboratory-Confirmed
    Interventions
    1. Biological: Tocilizumab
    MeSH:Laboratory Infection Neoplasms Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury
    HPO:Neoplasm Pneumonia

    Primary Outcomes

    Measure: Clinical outcome as evaluated by the 7-category Clinical Status Ordinal Scale

    Time: At least 60 days, up to 1 year
    18 Phase 1/2A Study of Rintatolimod and IFN-Alpha Regimen in Cancer Patients With Mild or Moderate COVID-19 Infection

    This prospective phase I/IIa trial studies the side effects of rintatolimod and Intron A (IFNa) alpha-2b in treating cancer patients with mild or moderate COVID-19 infection. Interferon alpha is a protein important for defense against viruses. It activates immune responses that help to clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to mimic viral infection by stimulating immune pathways that are normally activated during viral infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to limit the replication and spread of the virus.

    NCT04379518
    Conditions
    1. Malignant Neoplasm
    2. SARS Coronavirus 2 Infection
    Interventions
    1. Biological: Recombinant Interferon Alfa-2b
    2. Drug: Rintatolimod
    MeSH:Infection Communicable Diseases Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: This refers to the frequency of grade 3 or 4 AEs considered to be possibly, probably or definitely related to the treatment regimen. Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE version [v] 5.0).

    Measure: Incidence of adverse events (AEs)

    Time: Up to 30 days post treatment intiation

    Description: will be evaluated based on quantitative polymerase chain reaction PCR

    Measure: Kinetics of viral load in nasopharyngeal swabs

    Time: Up to 30 days post treatment initiation

    Secondary Outcomes

    Description: Will be analyzed using quantitative polymerase chain reaction (PCR).

    Measure: Kinetics of viral load in the peripheral blood and nasopharyngeal swabs

    Time: During the course of treatment up to day 30

    Description: The circulatory inflammatory mediators include C-reactive protein (CRP), cytokines, chemokines, interferons.

    Measure: Kinetics of changes of the immune subsets and circulating inflammatory mediators in peripheral blood

    Time: During the course of treatment up to day 30

    Description: The binary endpoint of 30-day mortality will be analyzed using a logistic regression model.

    Measure: 30-day mortality

    Time: At 30 days post treatment initiation

    Description: Rate of hospitalization due to infection

    Measure: Hospitalization due to infection

    Time: Up to 30 days post treatment initiation

    Description: Will be tested in nasopharyngeal swabs and blood cells of patients

    Measure: Determine known mediators of antiviral immunity

    Time: UP to 30 days post treatment initiation

    Other Outcomes

    Description: ARDS will be defined by Berlin criteria

    Measure: acute respiratory distress syndrome (ARDS)

    Time: Up to 30 days post treatment initiation

    Description: Need for mechanical ventilation

    Measure: respiratory failure requiring mechanical ventilation

    Time: up to 30 days post treatment initiation
    19 Myeloproliferative Neoplasms (MPN) and COVID-19

    An increased risk of both venous and arterial thromboembolism was noted in reports from SARS-CoV-2-infected patients in China and has been confirmed in autopsy findings from patients who experienced sudden death. Myeloproliferative Neoplasms (MPNs), which encompass polycythemia vera, essential thrombocythemia and primary myelofibrosis, are thrombophilic disorders with a natural propensity to thrombosis that is fuelled by the intrinsic activation of inflammatory cytokines. It therefore follows that an underlying diagnosis of MPN may increase the risk of worse clinical outcomes and death during periods of active Covid-19 disease. This ambispective, observational study aims to elucidate the key factors which affect the clinical course of patients with MPN who develop Covid-19 disease.

    NCT04385160
    Conditions
    1. Myeloproliferative Neoplasm
    2. COVID
    MeSH:Neoplasms Myeloproliferative Disorders
    HPO:Myeloproliferative disorder Neoplasm

    Primary Outcomes

    Description: Incidence of cases of MPN patients with COVID-19 experiencing pulmonary embolism

    Measure: pulmonary embolism (PE)

    Time: 2 and a half months

    Secondary Outcomes

    Description: Incidence of cases reporting at least one fatal or non fatal thrombotic event reported in therapy of MPN

    Measure: fatal or non fatal thrombotic event

    Time: 2 and a half months

    Description: Incidence of cases reporting at least one COVID-19 worsening outcome as Continuous Positive Airway Pressure (CPAP)

    Measure: Continuous Positive Airway Pressure (CPAP)

    Time: 2 and a half months

    Description: Incidence of cases reporting at least one COVID-19 worsening outcome as invasive ventilation

    Measure: invasive ventilation

    Time: 2 and a half months

    Description: Incidence of cases reporting at least one COVID-19 worsening outcome as Intensive Care Unit (ICU)

    Measure: admission in Intensive Care Unit (ICU)

    Time: 2 and a half months

    Description: incidence of death

    Measure: death

    Time: 2 and a half months

    Description: Type of treatments and interventions applied for MPN during COVID-19 and any change reported in therapy of MPN

    Measure: treatments and interventions applied for MPN

    Time: 2 and a half months

    Description: Type of treatments and interventions applied for COVID-19

    Measure: treatments and interventions applied for COVID-19

    Time: 2 and a half months

    Description: Odds Ratios (ORs) of the outcome and 95% Confidence Intervals (CIs) associated with patients' characteristics and treatments

    Measure: thrombotic events association to patients characteristic and treatments

    Time: 2 and a half months
    20 NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study

    This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

    NCT04387656
    Conditions
    1. COVID-19 Infection
    2. Hematopoietic and Lymphoid Cell Neoplasm
    3. Malignant Solid Neoplasm
    Interventions
    1. Procedure: Biospecimen Collection
    2. Other: Data Collection
    3. Other: Quality-of-Life Assessment
    4. Other: Questionnaire Administration
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: Distinguish the likelihood of severe COVID19 (for example, requiring hospitalization, requiring intensive care unit [ICU] treatment or requiring a ventilator) and death due to COVID-19 for patients with versus without the factor. Among subgroups of at least 50 patients, evaluate using chi-square tests as well as death and hospitalization rates.

    Measure: Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity

    Time: Up to 2 years

    Description: Describe the degree to which COVID-19 interrupts, delays, or otherwise alters cancer treatment for pediatric patients and subgroups of adult patients defined by cancer type and/or treatment modality. Describe the association between changes in cancer therapy and clinical outcomes. Evaluate association of COVID-19 with outcome by comparison to historical controls in subgroups of at least 50 patients using log rank tests to assess time to survival event.

    Measure: Effects of COVID-19 on cancer therapy and association with clinical outcomes

    Time: Up to 2 years

    Description: Will be measured using items from the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Profile.

    Measure: Physical health (patient-reported health-related quality of life)

    Time: Up to 2 years

    Other Outcomes

    Description: Analysis will include time to development of antibodies, prevalence of cytokine abnormalities, and genome-wide association study (GWAS) to define genetic polymorphisms associated with severe COVID-19 disease/mortality.

    Measure: Collection of blood specimens for future biomarker studies

    Time: Up to 2 years
    21 Randomised, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies

    The primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological malignancies.

    NCT04392128
    Conditions
    1. COVID19
    2. Hematologic Malignancy
    Interventions
    1. Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil]
    2. Drug: Azithromycin 250 MG Oral Capsule
    3. Drug: Placebo oral tablet
    4. Drug: Placebo oral capsule
    MeSH:Neoplasms Hematologic Neoplasms
    HPO:Hematological neoplasm Leukemia Neoplasm

    Primary Outcomes

    Description: Locally evaluated rate of viral response. Favorable response is defined as (1) complete response : negative PCR (absence of detectable signal with a minimum of 40 cycles) or (2) major response : detectable signal but with an increased number of cycles > or egal to 10 compared to initial PCR. Response failure is defined as (1) minor response : detectable signal but with an increased number of cycles < 10 compared to initial PCR or (2) stabilisation or worsening of the viral load.

    Measure: Evaluation of the efficacy of hydroxychloroquine and azithromyncine on the viral load drop at day 5.

    Time: 5 days of treatment

    Secondary Outcomes

    Description: Duration of fever - duration of respiratory symptoms (cough, dyspnea) - duration of other COVID-19 related symptoms (digestive symptoms, ageusia, anosmia)

    Measure: Clinical evolution

    Time: up to 3 months

    Description: Less or equal to 94% oxygen saturation - need to initiate oxygenotherapy - occurrence of respiratory distress - patient transfer in intensive care unit - need of mechanical ventilation - occurrence of non-respiratory organ failure - occurrence of septic shock

    Measure: Proportion of patients progressing to a severe form

    Time: up to 3 months

    Description: Date and cause of death

    Measure: Mortality

    Time: up to 1 and 3 months

    Description: SARS-CoV-2 viral load by PCR on nasopharyngeal swab at day 10 (if positive at day 5) : rate of negativation and comparison of number of cycles with previous samples

    Measure: Evaluation of viral load drop

    Time: at day 10

    Description: Frequence and causality of all-grade cardiac adverse events - frequence and causality of grade > 1 adverse events for other adverse events - frequence and causality of serious adverse events (CTCAE v5)

    Measure: Tolerance of study treatment

    Time: up to 3 months

    Description: Collection of serum to realize serological tests

    Measure: Evaluation of the seroconversion

    Time: at inclusion, day 10, day 30 and day 90 after treatment

    Description: Phenotypic and functional study of NK lymphocytes at inclusion, Retrospective analysis on frozen cells.

    Measure: NK immunological study

    Time: at day 10 and day 30 after treatment

    Description: Duration of hospitalisation (conventional, intensive care, reanimation)

    Measure: Hospitalisation duration

    Time: up to 3 months

    Description: Patient follow-up during 3 months : hematological status and associated therapy

    Measure: Impact of the study treatment on the treatment of the hematological disease

    Time: up to 3 months

    Description: ECG (using connected machine to allow monitoring at home)

    Measure: Monitoring of the QT space

    Time: at inclusion, day 2, day 5, day 10

    Description: Dosage of residual concentration of azithromycine and hydroxychloroquine.

    Measure: Dosage of residual concentration of azithromycine and hydroxychloroquine.

    Time: at day 5 and day 10

    Description: Phenotypic and functional study of T lymphocytes at inclusion, Retrospective analysis on frozen cells.

    Measure: T immunological study

    Time: at day 10 and day 30 after treatment
    22 An Observational Study to Identify the Issues and Challenges in Cancer Patients on Active Treatment During the COVID-19 Pandemic and the Resulting Lockdown

    In view of increasing cases of SARS-CoV-2 leading to the COVID-19 Pandemic in India,there has been unprecedented restrictions on travel, work and other aspects of daily life. Our study has been designed to collect data of cancer patients to analyze their issues and challenges during Covid-19 Pandemic.

    NCT04406844
    Conditions
    1. Oncology Patients
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: To focus on basic issues encountered by oncology patients such as transportation, medical facility, healthcare support, disease apprehension etc

    Measure: Oncology patients

    Time: 4-8 weeks
    23 Oncological Surgery in Times of COVID-19: Effectiveness of Preoperative Screening for Sars-Cov-2

    To evaluate the incidence of patients with a positive test for SARS-CoV-2, performed in the preoperative screening for patients treated at the institution

    NCT04434261
    Conditions
    1. SARS-CoV-2
    2. Oncology
    3. Surgery
    Interventions
    1. Diagnostic Test: PT-PCR test for SARS-CoV-2
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: Describe the incidence of patients with a positive test for SARS-CoV-2, detected in the preoperative screening program in our center

    Measure: Incidence of patients with a positive test for SARS-CoV-2, detected in the preoperative screening program

    Time: May- December 2020

    Secondary Outcomes

    Description: Describe the incidence of SARS-CoV-2 infection in the postoperative period in patients with negative screening test.

    Measure: Incidence of SARS-CoV-2 infection in the postoperative period in patients with negative screening test;

    Time: Up to 30 days

    Description: Postoperative complications will be recorded, according to the Clavien-Dindo classification.

    Measure: Postoperative complications

    Time: Up to 30 days

    Description: To evaluate the risk of all-cause mortality

    Measure: Mortality

    Time: 30 days

    Description: Assess the impact of delayed cancer treatment

    Measure: Delay in the cancer treatment

    Time: May 2020- March 2021
    24 Longitudinal Prospective Cohort Study to Describe the Clinical Characteristics of COVID-19, the Acquired Immune Response and the Biological and Clinical Parameters of Patients Followed in Oncology by the Saint-Joseph Hospital Group, Paris, France for a Period of 6 Months During the COVID-19 Pandemic in 2020

    This registry will allow to evaluate the correlation of the incidence and evolution of associated symptoms of infection of COVID-19 with the biological and clinical parameters in patients followed in Oncology during the COVID-19 pandemic.

    NCT04437719
    Conditions
    1. Oncology
    2. COVID-19
    Interventions
    1. Other: Obvio-19 app
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: Evaluation of the proportion of patients with COVID-19 infection's symptoms known to be associated with COVID-19 diagnosis (fever, cough, loss of taste and smell, sore throat, muscle pain, diarrhea, fatigue, difficulty eating and drinking and shortness of breath) followed during a period of 6 months.

    Measure: COVID-19 infection's symptoms

    Time: Observational period of 6 months

    Secondary Outcomes

    Description: To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 6 months.

    Measure: Incidence and course of symptoms of COVID-19 infection

    Time: During a period of 6 months

    Description: To establish the correlation of the COVID-19 infection with the biological and clinical data of patients from the Oncology cohort of the Groupe hospitalier Paris Saint-Joseph in Paris followed during a period of 6 months.

    Measure: Correlation of the COVID-19 infection with the biological and clinical data of patients

    Time: After a period of 6 months
    25 Randomized Double-Blind Phase 2 Trial of Ibrutinib Versus Standard Treatment for COVID-19 Illness Requiring Hospitalization With Safety Lead-In

    This phase Ib/II trial studies the side effects and best dose of ibrutinib and how well it works in treating patients with COVID-19 requiring hospitalization. Ibrutinib may help improve COVID-19 symptoms by lessening the inflammatory response in the lungs, while preserving overall immune function. This may reduce the need to be on a ventilator to help with breathing.

    NCT04439006
    Conditions
    1. Aplastic Anemia
    2. Hematopoietic and Lymphoid Cell Neoplasm
    3. Malignant Solid Neoplasm
    4. Monoclona
    5. Monoclonal B-Cell Lymphocytosis
    6. Monoclonal Gammopathy of Undetermined Significance
    7. Myelodysplastic Syndrome
    8. Symptomatic COVID-19 Infection Laboratory-Confirmed
    Interventions
    1. Other: Best Practice
    2. Drug: Ibrutinib
    MeSH:Laboratory Infection Neoplasms Myelodysplastic Syndromes Anemia, Aplastic Paraproteinemias Monoclonal Gammopathy of Undetermined Significance Lymphocytosis
    HPO:Aplastic anemia Erythroid hypoplasia Hypoplastic anemia Lymphocytosis Myelodysplasia Neoplasm

    Primary Outcomes

    Description: Associations between baseline characteristics and the primary endpoint will be evaluated with logistic regression, adjusting for arm. These analyses will be largely descriptive, as a result of a limited sample size.

    Measure: Proportion of patients with diminished respiratory failure and death

    Time: During hospitalization for COVID-19 infection or within 30 days of registration

    Measure: Death

    Time: During hospitalization for COVID-19 infection or within 30 days of registration

    Secondary Outcomes

    Description: Fever-free will be assessed by a temperature of < 100.5 degrees Fahrenheit orally. Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.

    Measure: Time from study initiation to 48 hours fever-free

    Time: Up to 14 days

    Description: Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.

    Measure: Duration of hospitalization

    Time: Up to 14 days

    Measure: Time in intensive care unit (ICU)

    Time: Up to 14 days

    Measure: Time to ICU admission

    Time: Up to 14 days

    Measure: Number of days requiring supplemental oxygen

    Time: Up to 14 days

    Measure: Total days of mechanical ventilation

    Time: Up to 14 days

    Measure: Time to mechanical ventilation

    Time: Up to 14 days

    Measure: Shock and need for pressure support

    Time: Up to 14 days

    Measure: Incidence of any infection (viral, fungal, bacterial)

    Time: Up to 14 days

    Measure: Time to clinical resolution

    Time: Up to 14 days

    Description: Adverse events will be summarized by grade, type, and attribution (regardless of attribution and treatment-related) for each arm.

    Measure: Incidence of grade 3 or higher adverse events

    Time: Up to 12 months

    Description: The proportion of patients with viral clearance at the time of hospital discharge will be estimated with 95% confidence intervals for each arm.

    Measure: At the end of therapy (day 14)

    Time: Up to 14 days

    Description: Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.

    Measure: Time to viral clearance

    Time: Up to 12 months

    Description: Patients will be followed for up to 12 months or until death or withdrawal of study consent for further follow-up. Following hospitalization, study visits will be telephone or video encounters.

    Measure: Survival

    Time: Up to12 months
    26 A Double-Blind, Randomized, Placebo-Controlled Phase II Study of Lopinavir/Ritonavir Versus Placebo in COVID-19 Positive Patients With Cancer and Immune Suppression in the Last Year

    This phase II trial studies how well lopinavir/ritonavir works in treating COVID-19 positive patients with cancer and a weakened immune system (immune-suppression) in the last year and have mild or moderate symptoms caused by COVID-19. Lopinavir/ritonavir may help to lessen or prevent COVID-19 symptoms from getting worse in cancer patients.

    NCT04455958
    Conditions
    1. Hematopoietic and Lymphoid Cell Neoplasm
    2. Malignant Solid Neoplasm
    3. Symptomatic COVID-19 Infection Laboratory-Confirmed
    Interventions
    1. Drug: Lopinavir/Ritonavir
    2. Drug: Placebo Administration
    3. Other: Questionnaire Administration
    MeSH:Laboratory Infection Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: Will be compared to the time of randomization. The severity of symptoms will be categorized as mild, moderate, severe, or critical according to the grading of symptoms. The proportion of participants with progression to more severe symptoms between treatments groups will be compared using a Fisher's Exact test at a 0.05 significance level.

    Measure: Severity of symptoms

    Time: 3 months

    Secondary Outcomes

    Description: Will be defined as improvement on symptoms: yes or no. Will be compared between treatment groups using log-rank test. A 95% confidence interval of treatment rate difference in symptom progression will be calculated by the Wald method.

    Measure: Clinical benefit rate of lopinavir/ritonavir

    Time: 3 months

    Description: Will be compared between treatment groups using log-rank test.

    Measure: Time to symptom progression

    Time: From randomization to the first documented symptoms progression, assessed up to 3 months

    Description: Will be compared between treatment groups using log-rank test.

    Measure: Time to improvement of participants

    Time: From randomization to first documented complete resolution of symptoms, assessed up to 3 months

    Description: Will be compared between treatment groups using log-rank test.

    Measure: Time to hospital admission for those who develop severe of critical symptoms

    Time: From time of randomization to the time of hospital admission, assessed up to 3 months

    Description: Will be compared using Fisher's exact test, and point and interval estimates will be provided.

    Measure: Intensive care unit (ICU) admission: yes or no

    Time: 3 months

    Description: Will be compared using Fisher's exact test, and point and interval estimates will be provided.

    Measure: Receiving ventilator support: yes or no

    Time: 3 months

    Description: Will be compared using Fisher's exact test, and point and interval estimates will be provided.

    Measure: Overall survival

    Time: From randomization to death due to any cause, assessed up to 3 months

    Other Outcomes

    Description: Will be compared between treatments group using t-test or non-parametric comparison if the distribution of lab values are deviated from normal distribution. The proportion of participants of whom lab values are obtained will be tabulated and compared using the chi-square test.

    Measure: Potassium level

    Time: 3 months

    Description: Will be compared between treatments group using t-test or non-parametric comparison if the distribution of lab values are deviated from normal distribution. The proportion of participants of whom lab values are obtained will be tabulated and compared using the chi-square test.

    Measure: Blood oxygen level

    Time: 3 months

    Description: Will be compared between treatments group using t-test or non-parametric comparison if the distribution of lab values are deviated from normal distribution. The proportion of participants of whom lab values are obtained will be tabulated and compared using the chi-square test.

    Measure: Creatinine level

    Time: 3 months

    Description: Will be compared between treatments group using t-test or non-parametric comparison if the distribution of lab values are deviated from normal distribution. The proportion of participants of whom lab values are obtained will be tabulated and compared using the chi-square test.

    Measure: Blood pressure

    Time: 3 months

    Description: Will evaluate on a subjective basis the ability to remotely consent, monitor and treat patients in the context of a pandemic of a contagious disease. The proportion of participants able to be remotely consented, monitored, and treated in the context of a pandemic of a contagious disease will be tabulated and compared using the chi-square test.

    Measure: Ability to remotely consent, monitor, and treat patients in the context of a pandemic of a contagious disease

    Time: 3 months
    27 Remote COVID-19 Symptom Tracking and Improved Cancer Symptom Control for Cancer Patients at Home During the Pandemic

    This project will evaluate the benefit of an automated home symptom monitoring system, Symptom Care at Home, to track COVID-19 symptoms, provide instructions to reduce COVID-19 exposure, and reduce cancer symptom severity during the COVID-19 pandemic. The investigators will determine if Symptom Care at Home decreases the need for cancer patients to use emergency departments and hospitalization for cancer symptom care. The project addresses the urgent public health need for cancer patients to reduce their risk for COVID-19 exposure.

    NCT04464486
    Conditions
    1. Oncology
    Interventions
    1. Other: SCH Intervention
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: Retrospective chart review of health care utilization of both groups

    Measure: Health Care Utilization Comparison

    Time: 5 months

    Secondary Outcomes

    Description: Patient Reported Outcomes Measurement Information System- Short Form v2.0 Social Isolation- 6a. The PROMIS Social Isolation item bank assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. The item bank does not use a time frame (e.g. over the past seven days) when assessing social isolation. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Social Isolation, a T-score of 60 is one SD worse than average. By comparison, a Social Isolation Tscore of 40 is one SD better than average.

    Measure: Patient Social Isolation

    Time: Monthly for 5 months

    Description: Patient reported outcomes collected in automated SCH system daily of COVID-19 symptoms, social distancing and hygiene practices, and COVID-19 related cancer treatment impacts and daily living impacts on cancer patients receiving the SCH -COVID intervention. The investigators will describe patterns of cancer patients and their adherence to social distancing and hygiene practices over time.

    Measure: COVID-19 Symptoms, Social distancing and Hygiene Practices

    Time: Daily for 5 months

    Description: Patient Reported Outcomes Measurement Information System Scale v1.2- Global Health Survey Short Form 10. High scores reflect better functioning. To find the total raw score for these scales with all questions answered, sum the values of the response to each question for a given respondent.

    Measure: Patient Global Health

    Time: Monthly 5 months

    Description: Hospital Anxiety and Depression Scale (HADS) measurement of psychological distress in non-psychiatric patients.

    Measure: Patient Anxiety/Depression

    Time: Monthly 5 months

    Description: COVID-19: Impact of the Pandemic and Health Related Quality Of Life (HRQOL) in Cancer Patients and Survivors

    Measure: Impact of Pandemic and Health Related Quality of Life

    Time: Baseline then 3 months and 5 months from baseline

    Description: Patient reported outcomes collected in automated SCH system daily of cancer symptom severity on a scale of 0-10 with 0 being no pain and 10 being worst pain imaginable. Description of symptom severity over time will be reported

    Measure: Cancer symptom severity

    Time: Daily for 5 months.
    28 Well-Being and Quality of Life in Cancer Patients and Survivors During the COVID-19 Pandemic

    This study investigates the well-being and health-related quality of life in cancer patients and survivors during the COVID-19 pandemic. Using questionnaires may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

    NCT04500600
    Conditions
    1. COVID-19 Infection
    2. Hemat
    3. Hematopoietic and Lymphoid Cell Neoplasm
    4. Malignant Solid Neoplasm
    Interventions
    1. Other: Quality-of-Life Assessment
    2. Other: Questionnaire Administration
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

    Measure: Experiences during the coronavirus disease 2019 (COVID-19) pandemic

    Time: 2 months

    Description: This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

    Measure: COVID-19-specific psychological distress

    Time: Up to 2 months

    Description: This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

    Measure: COVID-19-specific health

    Time: Up to 2 months

    Description: This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

    Measure: COVID-19-specific financial and social disruptions

    Time: Up to 2 months

    Description: This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

    Measure: COVID-19-specific perceived benefits and social support

    Time: Up to 2 months

    Description: This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

    Measure: COVID-19-specific health related quality of life (HRQoL)

    Time: Up to 2 months

    Description: Will evaluate the extent to which resiliency factors such as social support and perceived benefits moderate the effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL.

    Measure: Effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL

    Time: Up to 2 months
    29 A Phase 1/2 Trial of Leflunomide for the Treatment of Severe COVID-19 in Patients With a Concurrent Malignancy

    This phase I/II trial investigates the best dose and side effects of leflunomide and how well it works in treating patients with COVID-19 and a past or present cancer. Leflunomide has been used since the 1990s as a treatment for rheumatoid arthritis. Experiments done with human cells that were given severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19, showed that leflunomide was able to reduce the ability of the virus to make copies of itself. The coronavirus uses ribonucleic acid (RNA), a very long molecule that contains genetic information that is like a blueprint for making more copies of itself. Leflunomide inhibits the formation of RNA. The information gained from this study may help researchers to learn whether leflunomide is safe for use in treating patients with COVID-19, and whether it is potentially effective against the disease.

    NCT04532372
    Conditions
    1. Hematopoietic and Lymphoid Cell Neoplasm
    2. Malignant Solid Neoplasm
    3. Symptomatic COVID-19 Infection Laboratory-Confirmed
    Interventions
    1. Other: Best Practice
    2. Drug: Leflunomide
    3. Drug: Placebo Administration
    MeSH:Laboratory Infection Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study of treatment and reversibility or outcome.

    Measure: Incidence of toxicity, graded according to the NCI CTCAE version 5

    Time: Up to 28 days after completion of study treatment

    Description: Will be based on the assessment of dose limiting toxicity (DLT).

    Measure: Maximum tolerated dose (MTD) (Phase 1)

    Time: During the 28-day treatment period

    Description: Defined as a >= 2-point change in clinical status from day 1 on a 7-point ordinal scale.

    Measure: Clinical activity (Response)(Phase 2)

    Time: At day 28

    Secondary Outcomes

    Description: Defined as time from start of treatment to >= 2 point change in clinical status on a 7 point ordinal scale

    Measure: Time to Clinical activity (Response)

    Time: Up to 28 days

    Description: Defined as time from start of treatment to death from any cause

    Measure: Overall Survival

    Time: Up to 90 days

    Description: Time from start of treatment to peripheral capillary oxygen saturation (SpO2) > 93% on room air

    Measure: Oxygen Saturation improvement

    Time: Up to 90 days

    Description: Time from start of treatment to first negative severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) result assessed by polymerase chain reaction (PCR).

    Measure: SARS-CoV-2 resolution

    Time: Up to 90 days

    Description: Hospitalized within first 90 days following start of treatment assessed as yes/no

    Measure: Hospitalization

    Time: Up to 90 days

    Description: Indication as to whether or not the subject required mechanical ventilation at any time from start of treatment through 90 days post; assessed as yes/no

    Measure: Mechanical Ventilation required

    Time: Up to 90 days

    Description: If the subject required mechanical ventilation, indicate number of days for first occurrence; measured in days.

    Measure: Mechanical Ventilation duration

    Time: Up to 90 days

    Description: Vital status will be reported as yes/no

    Measure: Vital status (alive/dead)

    Time: Up to 90 days

    Description: If vital status is dead, cause of death will be documented.

    Measure: Vital status (cause of death)

    Time: Up to 90 days

    Other Outcomes

    Description: Measured by PCR assay of viral ribonucleic acid (RNA) from nasopharyngeal swab.

    Measure: Viral load

    Time: from start of treatment to 90 days
    30 Adaptation and Pilot Feasibility of a Psychotherapy Intervention for Latinos With Advanced Cancer

    The purpose of this study is to adapt a counseling intervention called Meaning Centered Psychotherapy to make it culturally relevant for Latinos. Cancer affects patients and their loved ones. Latinos often experience greater challenges due to the cancer. However, few studies and interventions focus on Latinos. We are interested in understanding what affects Latino patients' quality of life, and how to improve it

    NCT04537936
    Conditions
    1. Solid Tumor
    2. Solid Tumor, Adult
    3. Solid Tumor, Unspecified, Adult
    Interventions
    1. Behavioral: Meaning Centered Psychotherapy for Latinos
    2. Behavioral: Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale
    3. Behavioral: Meaning Centered Psychotherapy for Latinos for Waitlist Control Patients
    4. Behavioral: Pre-assessment questionnaire
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: FACIT Spiritual Well-Being Scale is a brief self-report measure designed to assess the nature and extent of individual spiritual well-being. This measure, which generates two sub-scales, one corresponding to Faith (the importance of faith and spirituality) and a second assessing Meaning-Peace (one sense of meaning and purpose in life), has been demonstrated to have strong internal reliability for both the total score as well as each subscale (coefficient alpha equals .87 for the total scale, .88 for the faith factor and .81 for the meaning factor). In additional, strong support for the external validity of this measure has been demonstrated in a several large samples of cancer and AIDS patients and with Spanish speaking populations.

    Measure: Spiritual Well-Being measured with the FACIT Spiritual Well-Being Scale

    Time: Change from baseline to post assessment 7-14 weeks after

    Secondary Outcomes

    Description: The Hospital Anxiety and Depression Scale (HADS) is a validated scale used to measure anxiety and depression. This scale has been validated against structured or semi-structured clinical interviews, the gold standard for the assessment of mental disorders, in a significant number of studies. Further strengths of this scale for the assessment of emotional distress in cancer patients stem from the joint assessment of anxiety and depressive symptoms without referring to physical symptoms of anxiety or depression. Given the high comorbidity of anxiety of cancer as well as the systematic exclusion of confounding physical symptoms, the scale seems especially appropriate for use in this patient group. The HADS consists of 14 items which reflect a 7-item anxiety and a 7-item depression subscale. This scale has sound psychometric properties in Spanish.

    Measure: Depression and Anxiety measured with the Hospital Anxiety and Depression Scale

    Time: Change from baseline to post assessment 7-14 weeks after

    Description: The Beck Hopelessness Scale (BHS) comprises 20 true/false questions that assess degree of pessimism and hopelessness. Several studies have demonstrated a high degree of internal consistency and construct validity. Scores ranging from 4 to 8 typically indicate a "mild" degree of hopelessness, 9 to 12 correspond to "moderate" hopelessness, and scores about 12 reflect "severe" levels of hopelessness.

    Measure: Hopelessness measured with the Beck Hopelessness Scale

    Time: Change from baseline to post assessment 7-14 weeks after

    Description: The FACIT Spiritual Well-Being Scale (FACIT-Sp-12) is a brief self-report measure designed to assess the nature and extent of individual's spiritual well-being. This measure (range 0-48), which generates two sub-scales, Faith (the importance of faith/spirituality, range 0-16) and Meaning /Peace (one's sense of meaning and purpose in life, range 0-32). The total score for the FACIT-Sp scale is the sum of the two subscales Faith and Meaning /Peace. It has been demonstrated to have strong internal reliability for both the total score as well as each subscale (coefficient alpha = .87 for the total scale, .88 for the faith factor and .81 for the meaning factor). Higher scores represent a higher level of spiritual well-being, faith or meaning-peace. In addition, strong support for the external validity of this measure has been demonstrated in a several large samples of cancer and AIDS patients and with Spanish speaking populations. Administration time takes approximately 4 minutes.

    Measure: Quality of life measured with the FACIT Spiritual Well-Being Scale

    Time: Change from baseline to post assessment 7-14 weeks after
    31 Effect of a Telerehabilitation-exercise Intervention in Oncology Patients in the Covid-19 Pandemic

    The aim is to analyze the feasibility and effect of an online Therapeutic Exercise and Education programme (TEEP) in cancer patient and survivors

    NCT04547634
    Conditions
    1. Cancer Metastatic
    2. Cancer
    3. Survivorship
    Interventions
    1. Other: Therapeutic Exercise and Education
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: Patients are asked before each session to mark in a numerical scale how are they feeling that day to push themselves and get their session well done. From 0 (very well) to 10 (very badly). Higher scores mean a worse feeling.

    Measure: Suitability of exercise intensity

    Time: Through study completion, an average of 3 months

    Description: Patients are asked to score the feeling of perceived effort after the session with the Borg Perceived Exertion scale (6-20). Higher scores mean a worse perceived exertion.

    Measure: Verification of exercise intensity

    Time: Through study completion, an average of 3 months

    Description: Total of days of attendance

    Measure: Total attendance

    Time: After intervention, an average of 3 months

    Description: Reasons of absence, categorized as: personal matter, visit the oncology, medical appointment (no related to oncology treatment), health problem, connection problem or unknown.

    Measure: Absence type

    Time: Through study completion, an average of 3 months

    Description: Attendance type, categorized as: full attendance, partly attendance because of lack of time, partly attendance because of internet connection problem

    Measure: Attendance type

    Time: Through study completion, an average of 3 months

    Secondary Outcomes

    Description: The Spanish version of the Piper Fatigue Scale-Revised (PFS-R) will be used. Its total score is the sum of all items (from 0 to 220), with higher values indicate a higher level of fatigue (worse outcome)

    Measure: Change from Cancer-Related Fatigue (CRF)

    Time: Prior and after intervention, an average of 3 months

    Description: It will be tested by 30-second Sit-To-Stand Test (30-STS), number of repetitions completed.

    Measure: Change from Functional capacity

    Time: prior and after intervention, an average of 3 months

    Description: the Spanish version of Upper Limb Functional Index (ULFI) questionnaire will be filled online

    Measure: Change from Upper limb functionality (%)

    Time: prior and after intervention, an average of 3 months

    Description: the Spanish version of Lower Limb Functional Index (LLFI) questionnaire will be filled online

    Measure: Change from Lower limb functionality (%)

    Time: prior and after intervention, an average of 3 months

    Description: It will be assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0. EORTC QLQ-C30 comprises 30 items and contains five functional scales, three symptom scales, a global health status/QoL scale, and six single items. Raw scores can be linearly converted to a 0-100 scale with higher scores reflecting higher levels of function (better outcome) and higher levels of symptom show bigger problems (worse outcome).

    Measure: Change from Quality of life (self-reported questionnaire)

    Time: prior and after intervention, an average of 3 months

    Description: It will be assessed by The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life questionnaire (EORTC QLQ-BR23). This is a breast cancer module of EORTC QLQ-C30 which contains 23 items that assess disease symptom, side effects of treatment, body image, sexual functioning, and future perspective. All items are rated on a 4-point scale (from 1- not at all, to very much). Higher scores represent better functioning (better outcome), and higher scores of symptom show bigger issues (worse outcome)

    Measure: Change from specific Breast Cancer Quality of life (self-reported questionnaire)

    Time: prior and after intervention, an average of 3 months
    32 Impacts of Coronavirus Disease 2019 (COVID-19) Pandemic on Adolescent and Young Adult (AYA) Cancer Patients and Survivors

    The study investigates how the COVID-19 pandemic has impacted the psychological, financial, physical, and social well-being of adolescent and young adult (AYA) cancer patients and survivors. AYA cancer survivors have inferior long-term survival compared to the general population, and the negative impact of the global COVID-19 pandemic may be even higher in this vulnerable group. The information gained from this study may provide an opportunity to determine the self-reported COVID-19 specific psychological distress in AYA cancer survivors, and may lead to the development of a targeted intervention to improve physical and psychosocial health for AYA cancer patients and survivors.

    NCT04551378
    Conditions
    1. COVID-19 Infection
    2. Hematopoietic and Lymphoid Cell Neoplasm
    3. Malignant Solid Neoplasm
    Interventions
    1. Other: Quality-of-Life Assessment
    2. Other: Survey Administration
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Description: Assessed per responses to the 12 questions pertaining to COVID-19 specific psychological stress within the adolescent and young adults (AYA) Cancer Survivor COVID-19 Survey section titled, "COVID-19 Related Distress (Emotional and Physical Reactions) and Health Behaviors.'' This survey includes both a 5-level Likert scale for the respondent's current level of concern (Not at all, A little, Neutral, A lot, Very Much), plus an ordinal 3-level scale for the respondent to rate the perceived level of change compared to before COVID-19 (Less, Same, More). Responses to individual questions will be summarized at each time point as means (for the Likert scale) and percentages (for discrete levels of change), together with 95% confidence intervals. For each question, will also summarize the percentages of patients in each group checking one of the 3 levels (Less, Same, More) indicating whether they perceived a change in that question since before COVID-19.

    Measure: Coronavirus disease 2019 (COVID-19) specific psychological stress

    Time: At baseline, 6 months, and 12 months

    Secondary Outcomes

    Description: Will be summarized by group and time point. Associations between endpoints and demographic, treatment-related and resilience variables, as well as differences among groups will be assessed by t-test, analysis of variance or Chi-square test. Non-parametric tests (Wilcoxon rank sum, Kruskal-Wallis, Fisher's exact) will be employed when appropriate. Regression models (e.g., linear, logistic etc.) will also be employed. Change from baseline to subsequent time points in Likert scores will be modeled by mixed-effect models, while blocking on patient to control for repeated measures. Models will include baseline demographic, treatment-related, and resilience factor variables as covariates.

    Measure: Survey responses

    Time: At baseline, 6 months, and 12 months

    Description: Will be summarized by group and time point. Associations between endpoints and demographic, treatment-related and resilience variables, as well as differences among groups will be assessed by t-test, analysis of variance or Chi-square test. Non-parametric tests (Wilcoxon rank sum, Kruskal-Wallis, Fisher's exact) will be employed when appropriate. Regression models (e.g., linear, logistic etc.) will also be employed. Change from baseline to subsequent time points in Likert scores will be modeled by mixed-effect models, while blocking on patient to control for repeated measures. Models will include baseline demographic, treatment-related, and resilience factor variables as covariates.

    Measure: Patient reported outcomes

    Time: At baseline, 6 months, and 12 months

    Description: Will be summarized by group and time point. Associations between endpoints and demographic, treatment-related and resilience variables, as well as differences among groups will be assessed by t-test, analysis of variance or Chi-square test. Non-parametric tests (Wilcoxon rank sum, Kruskal-Wallis, Fisher's exact) will be employed when appropriate. Regression models (e.g., linear, logistic etc.) will also be employed. Change from baseline to subsequent time points in Likert scores will be modeled by mixed-effect models, while blocking on patient to control for repeated measures. Models will include baseline demographic, treatment-related, and resilience factor variables as covariates.

    Measure: Changes of survey responses

    Time: At baseline, 6 months, and 12 months

    Description: Will be summarized by group and time point. Associations between endpoints and demographic, treatment-related and resilience variables, as well as differences among groups will be assessed by t-test, analysis of variance or Chi-square test. Non-parametric tests (Wilcoxon rank sum, Kruskal-Wallis, Fisher's exact) will be employed when appropriate. Regression models (e.g., linear, logistic etc.) will also be employed. Change from baseline to subsequent time points in Likert scores will be modeled by mixed-effect models, while blocking on patient to control for repeated measures. Models will include baseline demographic, treatment-related, and resilience factor variables as covariates.

    Measure: Changes in discrete responses

    Time: At baseline, 6 months, and 12 months

    Description: Will be separately modeled by logistic regression with relation to group and time point as well as demographic and cancer characteristics in order to assess factors associated with non-response and to assess associated bias. Other statistical approaches might be used as appropriate.

    Measure: Incidence of survey question non-response

    Time: At baseline, 6 months, and 12 months
    33 Preventing Viral Pandemic Associated Risk of Cancer Death Using Less Invasive Diagnostic Tests- Liquid Biopsies

    The purpose of this study is to investigate the feasibility of using ctDNA to support cancer diagnosis and risk stratification where invasive aerosol generating testing (and/or tissue biopsy) is challenging due to infection risk, technical impracticalities and resource limitations, such as during the COVID-19 pandemic and the subsequent recovery period.

    NCT04566614
    Conditions
    1. Neoplasm, Colorectal
    2. Ne
    3. Neoplasm of Lung
    4. Neoplasm, Bladder
    5. Neoplasms Pancreatic
    6. Biliary Tract Neoplasms
    7. Gastro Intestinal Stromal Tumour
    Interventions
    1. Other: ctDNA blood sampling
    MeSH:Neoplasms Biliary Tract Neoplasms Lung Neoplasms Colorectal Neoplasms Gastrointestinal Stromal Tumors Urinary Bladder Neoplasms
    HPO:Biliary tract neoplasm Bladder neoplasm Gastrointestinal stroma tumor Neoplasm Neoplasm of the large intestine Neoplasm of the lung

    Primary Outcomes

    Description: The primary endpoint, ctDNA detection rate, overall and within different cancer types will be presented as a proportion of patients with a positive ctDNA test out of those tested, with 90% confidence intervals

    Measure: ctDNA detection rate within different cancer types (and overall)

    Time: Throughout study completion, up to one year

    Secondary Outcomes

    Description: All secondary endpoints will be analysed in the patients diagnosed with suspected cancer, i.e. positive ctDNA result, unless stated. They will also be presented overall and by cancer type. The proportion of patients with positive ctDNA result which identified a diagnosis and/or commenced treatment will be presented as a proportion with 90% confidence intervals

    Measure: Proportion of patients with a positive ctDNA result which identified a diagnosis and/or commenced treatment

    Time: Throughout study completion, up to one year

    Description: Proportion of patients with positive ctDNA result which assisted in prioritising invasive diagnostic tests will be presented as a proportion with 90% confidence intervals

    Measure: Proportion of patients with a positive ctDNA result which assisted in prioritising invasive diagnostic tests

    Time: Throughout study completion, up to one year

    Description: The association between ctDNA result (positive versus negative) and the PREVAIL-imaging pathway scoring result will be assessed descriptively by presenting cross-tabulations and relevant proportions

    Measure: The association of ctDNA result (positive versus negative) and the PREVAIL-imaging pathway scoring result

    Time: Throughout study completion, up to one year

    Description: Simple estimation of the cost of liquid biopsy in lieu of tissue biopsy as compared to standard of care investigations and treatments prioritisation will be performed

    Measure: Estimation of the cost of liquid biopsy in lieu of tissue biopsy as compared to standard of care investigations and treatments prioritisation

    Time: Throughout study completion, up to one year
    34 An onLine-pLatform to Improve Patient-centered Care During the COVID-19 pAndemic: a GIMEMA surveillaNce Program in hematologiC malignanciEs

    This is a national multicenter prospective observational study led by the GIMEMA. The GIMEMA-ALLIANCE Platform is also an online monitoring system for patients with hematologic malignancies aiming at helping hematologists in the early recognition and timely management of problems of their patients. Based on patient's rating of specific items (i.e. on the presence of clinically relevant problems or problems with adherence to therapy or risk of SARS-CoV-2 infection), the Platform will automatically send alerts to the treating hematologist (and/or appointed members of the local Team). Physicians will be free to make any action they feel appropriate for the best care of their patients.

    NCT04581187
    Conditions
    1. Hematologic Malignancies
    Interventions
    1. Other: Quality of life assessment
    MeSH:Neoplasms Hematologic Neoplasms
    HPO:Hematological neoplasm Leukemia Neoplasm

    Primary Outcomes

    Description: To prospectively assess HRQOL in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)

    Measure: HRQOL in adult patients with hematologic malignancies

    Time: After 2 years from date of registration

    Description: To prospectively assess symptoms in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)

    Measure: Symptoms in adult patients with hematologic malignancies

    Time: After 2 years from date of registration

    Description: To prospectively assess adherence to therapy in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)

    Measure: Adherence to therapy in adult patients with hematologic malignancies

    Time: After 2 years from date of registration

    Secondary Outcomes

    Description: To describe the prevalence of clinically relevant functional limitations (e.g., physical and social) and symptoms (e.g., fatigue, pain and dyspnea) by type of hematologic malignancy and by type of treatment (e.g., standard chemotherapy of oral anticancer therapies)

    Measure: Prevalence of clinically relevant functional limitations and symptoms

    Time: After 2 years from date of registration

    Description: To investigate factors associated with physical and mental health concerns

    Measure: Factors associated with physical and mental health concerns

    Time: After 2 years from date of registration

    Description: To examine the financial and social impact imposed by the COVID-19 pandemic on patient health outcomes

    Measure: Financial and social impact imposed by the COVID-19 pandemic on patient health outcomes

    Time: After 2 years from date of registration

    Description: To examine the limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes

    Measure: Limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes

    Time: After 2 years from date of registration

    Description: To describe clinical strategies adopted by physicians in response to patient-generated alerts, across different clinical scenarios

    Measure: Clinical strategies adopted by physicians

    Time: After 2 years from date of registration
    35 A Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation

    This is a phase 1/2, open label study of D-1553 single agent and combination treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C mutation.

    NCT04585035
    Conditions
    1. Solid Tumor, Adult
    2. NSCLC
    3. CRC
    Interventions
    1. Drug: D-1553
    2. Drug: Other
    MeSH:Neoplasms
    HPO:Neoplasm

    Primary Outcomes

    Measure: Subject incidence of Dose-limiting toxicities (DLT)

    Time: through out the DLT period, approximately 21 days

    Measure: Number of subjects participants with adverse events

    Time: Through study completion, approximately 3 years

    Measure: Plasma concentration of D-1553 as a single agent or in combination with other therapies in subjects wiht advanced or metastatic solid tumors with KRas G12C mutation.

    Time: Through study completion, approximately 3 years
    36 Thromboembolic Risk Screening in Patients With Cancer and COVID-19

    Study Rational Since December 2019, outbreak of COVID-19 caused by a novel virus SARS-Cov-2 has spread rapidly around the world and became a pandemic issue. First data report high mortality in severe patients with 30% death rate at 28 days. Exact proportions of the reasons of death are unclear: severe respiratory distress syndrome is mainly reported which can be related to massive cell destruction by the virus, bacterial surinfection, cardiomyopathy or pulmonary embolism. The exact proportion of all these causes is unknown and venous thromboembolism could be a major cause because of the massive inflammation reported during COVID-19. High levels of D-dimers and fibrin degradation products are associated with increased risk of mortality and some authors suggest a possible occurrence of venous thromboembolism (VTE) during COVID-19. Indeed, COVID-19 infected patients are likely at increased risk of VTE. In a multicenter retrospective cohort study from China, elevated D-dimers levels (>1g/L) were strongly associated with in-hospital death, even after multivariable adjustment. Also, interestingly,the prophylactic administration of anticoagulant treatment was associated with decreased mortality in a cohort of 449 patients, with a positive effect in patients with coagulopathy (sepsis-induced coagulopathy score ≥ 4) reducing the 28 days mortality rate (32.8% versus 52.4%, p=0.01). However the presence/prevalence of VTE disease is unknown in COVID-19 cancer patients with either mild or severe disease. Cancer patients are at a higher risk of VTE than general population (x6 times) and could be consequently at a further higher of VTE during COVID-19, in comparison with non-cancer patients. The exact rate of VTE and pulmonary embolism during COVID-19 was never evaluated, especially in cancer patients, and is of importance in order to understand if this disease needs appropriate prophylaxis against VTE. The largest series of cancer patients so far included 28 COVID-19 infected cancer patients: the rate of mortality was 28.6%. 78.6% of them needed oxygen therapy, 35.7% of them mechanical ventilation. Pulmonary embolism was suspected in some patients but not investigated due to the severity of the disease and renal insufficiency, reflecting the lack of data in this situation. The aim of the present study is to analyze the rate of symptomatic/occult VTE in a cohort of patients with cancer. Expected benefits Anticipated benefits of the research are the detection of VTE in order to treat it for the included patient. For all COVID-19 positive cancer patients it will enable to provide some guidelines and determine which patient are at risk for VTE and which will need ultrasound to detect occult VTE. Foreseeable risks Foreseeable risks for patients are non-significant because the additional procedures needed are ultrasound exam, and blood sample test. Methodology Retrospective and prospective (ambispective), multicentric study to evaluate the occurrence of venous thromboembolism during COVID-19 infection. Indeed, because the outbreak can end within the next 3-6 months, Investigators may not be able to answer the question if Investigators only focus on patients investigated prospectively. Investigators then decided to include patients from medical team who are already systemically screening patients with COVID-19 disease for VTE. Trial objectives Main objective To evaluate the rate of venous thromboembolism at 23 days during COVID-19 infection in cancer patients.

    NCT04616846
    Conditions
    1. Neoplasms Malignant
    2. Covid19
    3. Thromboembolism
    Interventions
    1. Diagnostic Test: Peripheral venous ultrasound
    MeSH:Neoplasms Thromboembolism
    HPO:Neoplasm Thromboembolism

    Primary Outcomes

    Description: Deep venous thrombosis and/or pulmonary embolism.

    Measure: Rate of venous thromboembolism

    Time: From Day 9 to Day 42

    Secondary Outcomes

    Description: Rate of hospitalization

    Measure: Hospitalization due to venous thromboembolism

    Time: Day 23

    Description: Time between the date of inclusion and the date of death for any reason.

    Measure: Overall Survival

    Time: Day 23

    Description: Time between the date of inclusion and the date of death for venous thromboembolism.

    Measure: Specific survival

    Time: Day 23

    Description: Common toxicity criteria from the NCI CTCAE V5.0

    Measure: Safety profile using the common toxicity criteria from the NCI CTCAE V5.0

    Time: Day 1 to Day 23

    Description: Khorana score (low risk (score=0), medium risk (score=1 ou 2) and high risk (score ≥ 3)

    Measure: Predictive factors for venous thromboembolism

    Time: Day 1 to Day 23

    Description: Caprini score (very low risk (score=0), low risk (score=1 or 2), medium risk (score=3 or 4)and high risk (score ≥ 5)

    Measure: Predictive factors for venous thromboembolism

    Time: Day 1 to Day 23

    Description: Common toxicity criteria from the NCI CTCAE V5.0

    Measure: rate of symptomatic venous thromboembolism between the COVID-19 negative and COVID-19 positive patients

    Time: Day 1 to Day 23

    HPO Nodes


    HP:0002664: Neoplasm
    Genes 1537
    H19 RPS19 WT1 GPR101 CHEK2 MYD88 VEGFC PGM3 CTNNB1 PDGFRA IRF1 RHBDF2 PICALM FANCC GDNF RET PRKAR1A NELFA BCL10 KRT10 BLK TINF2 SMARCD2 NSD2 BRCA1 KRAS TRIP13 KCNH1 PERP CDH23 IKBKG MCC JAK2 MET GTF2E2 FOXC2 NF1 RAD51 TP53 ERCC4 WNT10A ASXL1 CTLA4 FLT4 DVL3 BRCA1 MLH3 NSD1 ERCC2 TSC2 FANCL RPS14 CDC73 TNFRSF4 STAG3 MSTO1 AIP EVC RET PLCD1 SDHB NEK1 POLH ASXL1 BRAF IL7 MAP2K1 ARSA BRAF COL4A5 CYLD KRT14 MLLT10 RASGRP1 H19 XIAP NTHL1 FGFR2 IGH DNAJC21 LETM1 MCM4 MYF6 CD70 FAM149B1 FGFR3 TERF2IP TNFRSF13C GLI3 DDX41 RPL26 PRLR SBDS LIG4 MGMT RERE KLLN FANCM WT1 PHB AXIN2 KIT PTEN TGFBR2 GJA1 PDGFRL STAT6 TYR CPLANE1 IFNG SIX6 JAG1 PALB2 SSX1 FANCG KIT MYO1H ELANE RPS19 H19-ICR KRT6B IDH2 PLCB4 FGFR1 BAP1 MINPP1 MST1 SMARCB1 PDGFRB RB1 FAT4 NF1 HFE SDHD WT1 TET2 BMPR1A RAF1 POLR1D CBFB SKIV2L IRF1 COL18A1 HMBS RET MMEL1 IGF2R JAK2 SEC23A BUB1B XPC ING1 AXIN2 KIT PALB2 MAGT1 STAC3 ALK SLC25A13 TMEM231 SHOX TDGF1 REST SMO SMARCA4 DNM2 TSR2 LIN28B GNAS WT1 CDKN1A DNAJC21 DKC1 BAP1 SRGAP1 ALX1 PTPN11 CBL APC SCN11A MAP3K1 RPL10 KLF6 PAX7 APC C1S NRTN BUB3 KRT5 LIG4 CARD14 GNAS MLH1 CDKN2A GNA11 TMEM127 ESR1 IL2RG KRT1 MET NF2 SDHAF2 SDHD WT1 MAP3K8 STAT1 PHOX2B PTPRJ PTCH2 CHD7 TERT LMNA ERCC6 EDNRB XPA PDGFRA OFD1 VHL SAMD9L SF3B1 FERMT1 BRCA1 GDF2 CASP8 TP53 LAMC2 GFI1B FANCD2 PYGL CR2 AR REST APPL1 APC CYP2A6 SEMA3C WT1 CDKN2A CTSA LRRC8A PHOX2B SMARCB1 NAGS FLI1 SOX2 RAD21 TMEM127 APC FGF3 BAP1 BUB1 RAD51 DKC1 RAD54B VHL EPCAM ASXL1 SRC HRAS BMP2 SLC25A11 PTH1R KRAS MYD88 NPM1 PTEN SH3GL1 PHOX2B TP53 SMAD4 XPA GATA4 MLH1 PMS2 STK11 FANCC DHCR7 PTCH1 CDC73 CYLD MEN1 CLCNKB CHEK2 RNF139 HABP2 POLE H19-ICR MMP1 RPL27 CC2D2A PIK3CA GPC3 ABL1 PALLD WASHC5 INTU ERCC5 DYNC2LI1 SLC22A18 TP53 CDH1 SHH MPL AKT1 NFKB2 NRAS PIGL CASP8 MYC KCNE3 DLST TAF15 TNFRSF13B GDNF EYA1 APC2 TNFRSF1B TCTN3 PPOX PNP PKHD1 BLM ODC1 IL12A TERT STK11 KRT17 IDH1 CIB1 RPL18 DVL1 ARHGAP26 PHOX2B CASP8 RPGRIP1L KRT6A SDHB FGFR2 VAMP7 JAK2 SRY DNMT3A EPAS1 KCNQ1OT1 MSH6 KRAS SDHB WNT5A DNMT3A RUNX1 TRIM28 DHCR24 USB1 VANGL2 GCM2 LIG4 KRAS SDHB ENG SEMA3D TRNS2 MINPP1 CASP10 NTHL1 LMOD1 SUFU FOXH1 CD81 ALX4 F13B BMPR1B RB1 CACNA1S CHIC2 VHL HRAS KIF11 KCNJ11 WRN SLC37A4 GNAQ LZTR1 CCND1 CPLX1 NR4A3 RYR1 NBEAL2 GATA2 TP63 APC KRAS HNF1B SUFU GNB1 MSX2 GPC3 CEL TCTN3 OCA2 MDM4 RB1 TMC6 ASCL1 AR BRIP1 CHEK2 AAGAB TSC1 TXNRD2 POLD1 CARMIL2 APC PIK3CA AKT1 POLE FAN1 RAD21 G6PC BRD4 PTCH2 MSH2 DHH EWSR1 SPRTN SDHC PTCH1 ALX3 CD79A TMEM67 INPP5E CCBE1 KRT6B BRCA2 ITK GINS1 HLA-DRB1 SNAI2 NBN PHOX2B BRAF CDH1 FANCE TYR GPC4 NF1 CD19 MVD AIP AR NBN TMEM107 BRIP1 ATRX BCHE MITF WRN BCR BCR NF2 SERPINA1 SDHB RABL3 PARN ANTXR2 TERT DPM1 IFIH1 GDF5 ZAP70 MEN1 TP53 GNAS BRCA2 TMC8 NODAL LETM1 VANGL1 TBXT BRCA1 FIBP FLT4 IL1B CCL2 FGFR3 SUFU MTAP ELANE CD19 HNF4A SAMD9 BUB1B KLHDC8B SLC26A2 FGFR3 FOXP1 PUF60 RUNX1 PTCH2 TRNK FLT4 TYROBP MPL KRAS RAD54L PIK3CA FAH CHEK2 CPLANE1 FAM20C CXCR4 DDR2 POU6F2 TMC6 SEC23B RET TRNP TFE3 TP53 NAB2 ANTXR1 MYSM1 SDHAF2 BTK TNFRSF10B DCLRE1C L2HGDH CDKN2A CYP11B2 BRCA2 SDHD TET2 TMEM216 BRAF PTCH2 TCF3 RPL11 NNT FLT3 BAX HAX1 IGF2 AKT1 FGFR3 MLH3 PLA2G2A TCF4 MLH3 NOTCH1 ERCC4 RRAS2 GPC4 DICER1 LZTS1 DOCK8 CASP10 GREM1 HPGD COL1A1 DCLRE1C IDH1 XRCC3 SUFU DNAJC21 PDGFRB TP53 NLRP1 WWOX TSC1 CTSC USP9X PDCD10 MEN1 ASCL1 RNF43 TNFRSF13C ESCO2 ZFPM2 AP2S1 PRCC HMBS ADA2 GANAB WT1 RNF43 HRAS KRAS SETD2 ATP6V1B2 FLT3 TJP2 BMPR1A PDGFB KIAA0753 PTEN STK4 NFKB1 BAP1 PMS1 MSR1 SLC26A2 RECQL4 MSH2 JAK2 ATRX FH RECQL4 FCN3 CD28 ASPSCR1 ADAR WHCR NOTCH3 GATA2 SMARCE1 CDKN2A RET ESCO2 EXT1 ERCC5 TET2 MBTPS2 NF1 OFD1 AGGF1 MVK KIT MUTYH HRAS KRIT1 FGFR1 TRIM28 CHEK2 CD79B GNAS BRCA2 KDSR BAX HACE1 MAP2K2 EDN3 ERCC2 CTNNB1 IL6 IGH PIK3CA MSH3 FZD2 SMPD1 SNAI2 PHOX2B SLC26A2 OFD1 PAX4 RB1 TRIP13 EWSR1 SCN9A PIK3R1 GBA EP300 PIK3CA HMMR KIT PDE6D ZSWIM6 SH3KBP1 SRP54 FUZ USP8 WT1 TERT MAFA FOXO1 GJB3 RAD51D POT1 SDHC PRKAR1A CREB1 SH2D1A WIPF1 WWOX PIK3CA NF2 HNF4A FAS RNASEH2A CD27 ATRX SPRED1 RPS14 FDPS RNR1 PALB2 NF1 MN1 TET2 GPC4 KDR SOX9 RAD51 MAX MYLK EP300 SHOX FOXE1 TCOF1 ESCO2 MYH11 HSPA9 MAD2L2 KRT9 CYP2D6 RFWD3 FANCE KRAS CCND1 LMO1 PTCH1 PORCN EDN3 PDGFRA DICER1 FANCA TERC CTBP1 SDHD ANTXR1 CXCR4 RAD50 BRCA2 MC1R MPL SLC22A18 MMP1 KRT16 F13A1 TSC2 ENG SETBP1 WT1 TET2 SDHC SMAD4 ZFHX3 GFI1 RNF113A STK11 KARS1 FOXE1 CDKN2B WT1 ERBB3 SMARCAD1 PDGFRL DMPK GTF2H5 NF2 CEBPA RPS28 PMS1 AKT1 PRDM16 NBN GCK SPINK1 ERBB2 JAK2 KIT DKC1 EXT1 JAK2 COL7A1 AXIN1 SLC22A18 NRAS ECM1 GNPTAB ABCA5 CDH1 NRAS ERCC6 VANGL1 RAD51C MYCN HBB TP53 SRY FANCI AKT1 MITF LEMD3 TARS1 TET2 NSD2 DAXX DYNC2LI1 OGG1 EXT1 TNFSF15 TERT ERCC6 DMRT3 SLC25A11 CTNNB1 VHL KLLN MLH3 EIF2AK4 GJB6 BARD1 OCRL GPR35 MYC DLST KRAS MSH3 RMRP PRKCD KLF6 NEUROD1 FANCG SLC17A9 BMPER FLCN SDHC SF3B1 STS GNA14 TERC MNX1 CAT TCF4 TUBB TRNQ BRCA2 IL12RB1 PDX1 CDKN2A SLC26A4 SDHC PPM1D NRAS PRKAR1A NRAS TAL1 KIF1B DNMT3A PDGFB MRAP ERCC3 CDC73 PRF1 RFWD3 PMVK RPL15 FGFR1 TP53 BICC1 HNF1A GATA1 RTEL1 RPS15A ERCC4 WRAP53 NR0B1 BCR FGFR2 SEC23A KRT17 NR5A1 VHL BLM BRAF ICOS POLD1 RPS27 FASLG CYSLTR2 PTEN PRKN THPO KIF7 NRAS TAL2 BRAF WDPCP DCC MSH6 NOP10 WNT10A PSAP ERCC2 CALR ACD SLX4 ACAN HABP2 GJB4 TET2 PHF21A ERCC3 MDH2 APC PALB2 RPL10 KRT17 PGM3 IL7R ARL6IP6 APC TCIRG1 NF1 SMAD4 PTPN3 PIK3CA ABCA5 FGFR2 TGFBR2 BRCA2 HNF1A RNASEH2C PAX6 IGH TTC37 DICER1 SRY GPC6 TOP2A KIT OFD1 PALB2 NRAS MC1R SDHD TFAP2A FGFR3 TNFRSF1B REST PTEN MST1R SCN4A BRCA2 CDKN2A FGFR2 ZIC2 EFL1 ECE1 NUP214 DDB2 GPC3 KCNQ1 PTEN HNF1B FN1 ASCC1 SPIB SRP72 PTEN FANCB KCNJ10 AKT1 KRAS KEAP1 INS DISP1 PTEN SASH1 CDKN1C ACTB TNFRSF13B MYH8 EDN1 IVNS1ABP NSUN2 TSC1 RAD51C MSH3 ATP7B RET PTPN12 STIM1 DHCR7 KRAS SFTPC BMPR1A XPC TMC8 KCNJ10 KDM6B STK11 KRAS GNAQ KRAS HFE HOXD13 B3GALT6 RPL5 KAT6B GATA2 MUC5B PIK3CA USP8 GDNF SMAD4 MVK RHBDF2 SSX2 CEP57 RAD51C NEK9 JAK2 PDGFB NRAS KRT1 PIK3CA MFN2 DOCK8 PTEN IL7 SDHC ATM AKT1 BRCA1 RELA GCDH PIK3CA IDH2 HRAS CTLA4 GPR143 ERCC2 GATA2 PTPN11 IGF2 SMAD4 NDUFAF6 CDH23 RPS7 RAD54B TP53 MUTYH GLI3 PTPN11 BRIP1 CDKN1B SF3B1 PTCH1 CIB1 ERCC3 PTPN11 TRPV3 GDNF IGLL1 PRKCD CTNNB1 PIK3CA PTPN11 SLCO2A1 FAH BRCA1 ETV6 BRCA2 EPCAM TP53 EXT1 BCL10 TRPS1 BMPR1A ATM MPL KRT17 MAX SLC12A3 ADA TERT UBE2T TSC2 TCTN3 MSH2 BDNF BTK SKI RPS20 NRAS RUNX1 DCC MSH2 RPS24 WT1 TRNF TFAP2A RPL35 RPS17 SDHA RARA CDC73 SBDS POLH BRAF LAMB3 RNF6 PIEZO2 KCNQ1OT1 CCM2 PHKA2 POU2AF1 TP53 TREM2 ABCC8 EXT2 ALK PHKG2 NUTM1 SLC26A4 PTCH1 MUTYH PALLD NBN FANCA SQSTM1 ELMO2 ACP5 TWIST1 TRIM37 RPL31 HFE RET DLC1 SDHB EP300 TREX1 HSPG2 ATP7A MSH6 C2CD3 CHRNG SRP54 TINF2 BUB1 PSENEN SMAD4 NF1 ERCC3 ARID1B RMRP WAS GATA2 MAPK1 BIN1 COL7A1 EDN3 PIK3CA IGF2 H19-ICR TUBB FH MLH1 TNFSF12 PIK3R1 RASA1 F5 SH2B3 CTNNB1 FOXI1 SUFU TLR2 SRSF2 CDKN1B GJC2 OPCML LEMD3 FIBP TRNS1 HNF1A VHL PTEN PRKAR1A MSH2 CYLD CTHRC1 COL7A1 DDB2 SDHC GJB2 LIG4 MDM2 LAMA3 CHEK2 MTOR CDON SMARCE1 TAF1 GNAQ TP53 RAD54L WWOX BMPR1A CCND1 GFI1 BCL10 PTEN CTNNB1 DHX37 SLX4 FGF8 XRCC4 TRIP13 CDC73 BIRC3 NOTCH3 DIS3L2 PKD2 KIF1B GNA11 ARMC5 CREBBP DIS3L2 HRAS LMX1B BAP1 BRCA2 POT1 ABCB11 AURKA RASA1 SMARCB1 ALX4 GPC3 MGAT2 PAX3 IGHM LMNA TCF4 GATA1 TRNK IDH1 LRP5 CALR FH RET SEC23B APC TET2 SETBP1 WT1 PMS2 POLR1C SIX3 EPHB2 RPL35A RET TINF2 CD28 CYP26C1 MNX1 ALX3 KIT CPOX GJB2 DLL1 MSTO1 RSPO1 TEK EXT2 ABCC6 COL2A1 GNAS FH FASLG BAP1 COL14A1 YY1 RAG2 RB1CC1 MAP2K1 RHOH STAR CREBBP RECQL4 EVC2 HBB ERBB2 ABL1 NDP SUFU NF2 MSH6 ATP7A TSC1 FAS SLC6A17 MS4A1 NQO2 FLCN EXTL3 SOS1 RNASEL NPM1 KIT GNAI3 TRNH RAG1 HRAS BUB1B IGF2 PLAG1 FANCD2 BCL2 NEK1 KIT ATP7A PIK3CA SMARCB1 PCGF2 LIG4 BCL6 NUP214 FLNA IRF5 ACVR1 GAS1 DYNC2H1 RSPRY1 TRAF7 RNASEH2B REST RPS29 TGIF1 TERT PIGA TP53 CDK4 GPR101 ACVRL1 SAMHD1 MSL3 MAPRE2 SLC45A2 CTNNB1 ADA KLF11 NKX2-1 GLI2 PKD1 MAP3K1 SRP54 TNFSF12 ND5 CRKL RASGRP1 BCL10 RPS26 GLI3 TRNL1 AR SDHA RB1 MLH1 MC2R TGFBR1 KIT CYP11B1 AXIN2 EGFR PIK3CA RECQL4 EXOC6B SMO SFTPA2 NRAS CDKN1B TP53 PIK3CA MSH6 ACTG2 POT1 SDHB RNF6 CALR KCNN3 C11ORF95 TSC2 CD96 SOS1 COL2A1 SMAD7 GLI1 FANCF MPL CDH1 BRCA2 BRAF ATR SDHA FLCN DICER1 IL1RN ICOS AIP RSPO1 DICER1 GCM2 XRCC2 DNASE1L3 PPP2R1B TGFBR2 MTM1 CDKN2C SIX1 MEN1 POU6F2 SRD5A3 STAT3 ERCC3 TG ASXL1 CDKN2B CYLD NHP2 CCDC22 TBC1D24 BLNK DIS3L2 SH2B3 MPLKIP AHCY PCNA EXT2 EXT2 MEN1 PARN WRAP53 TP53 HBB GABRD NUMA1 APC ZSWIM6 BRCA1 GJB2 KCNAB2 AIP USF3 RUNX1 H19 HDAC4 SDHD UROD PDGFRB CR2 HRAS CDH1 ERBB2 TNPO3 LPP SDHD IL2RG ATM BARD1 TREX1 POLE C2CD3 ERCC4 SLC25A13 PNP KRAS SRSF2 SDHB FGFR3 CASR CASP10 TET2 CTC1 ENPP1 SOX6 PIK3CA BMPR1A ERCC2 TERC CBL ADAMTS3 PIGL BCR SAMD9L NOD2 CBL TGFBR2 MALT1 SEMA4A ANTXR2 SLC37A4 TBX2 DHH STS SDHB TERT KRT16 DZIP1L RTEL1 SDHD CCND1 AKT1 FOXI1 CDK4 NSD1 MLH1 FLCN DLEC1 FGFRL1 MTMR14 GCGR TBX18 CREBBP MXI1 APC BCL10 COL11A2 TERT MC1R SCN10A RPS10 SMO BRCA2 KIT ATM PRKN MRE11 KIF1B KCNH1 VHL GPR101 GNAS PMS2 ACD WDPCP MAD1L1

    HPO

    Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


    HPO Nodes


    HP:0002664: Neoplasm
    Genes 1537
    H19 RPS19 WT1 GPR101 CHEK2 MYD88 VEGFC PGM3 CTNNB1 PDGFRA IRF1 RHBDF2 PICALM FANCC GDNF RET PRKAR1A NELFA BCL10 KRT10 BLK TINF2 SMARCD2 NSD2 BRCA1 KRAS TRIP13 KCNH1 PERP CDH23 IKBKG MCC JAK2 MET GTF2E2 FOXC2 NF1 RAD51 TP53 ERCC4 WNT10A ASXL1 CTLA4 FLT4 DVL3 BRCA1 MLH3 NSD1 ERCC2 TSC2 FANCL RPS14 CDC73 TNFRSF4 STAG3 MSTO1 AIP EVC RET PLCD1 SDHB NEK1 POLH ASXL1 BRAF IL7 MAP2K1 ARSA BRAF COL4A5 CYLD KRT14 MLLT10 RASGRP1 H19 XIAP NTHL1 FGFR2 IGH DNAJC21 LETM1 MCM4 MYF6 CD70 FAM149B1 FGFR3 TERF2IP TNFRSF13C GLI3 DDX41 RPL26 PRLR SBDS LIG4 MGMT RERE KLLN FANCM WT1 PHB AXIN2 KIT PTEN TGFBR2 GJA1 PDGFRL STAT6 TYR CPLANE1 IFNG SIX6 JAG1 PALB2 SSX1 FANCG KIT MYO1H ELANE RPS19 H19-ICR KRT6B IDH2 PLCB4 FGFR1 BAP1 MINPP1 MST1 SMARCB1 PDGFRB RB1 FAT4 NF1 HFE SDHD WT1 TET2 BMPR1A RAF1 POLR1D CBFB SKIV2L IRF1 COL18A1 HMBS RET MMEL1 IGF2R JAK2 SEC23A BUB1B XPC ING1 AXIN2 KIT PALB2 MAGT1 STAC3 ALK SLC25A13 TMEM231 SHOX TDGF1 REST SMO SMARCA4 DNM2 TSR2 LIN28B GNAS WT1 CDKN1A DNAJC21 DKC1 BAP1 SRGAP1 ALX1 PTPN11 CBL APC SCN11A MAP3K1 RPL10 KLF6 PAX7 APC C1S NRTN BUB3 KRT5 LIG4 CARD14 GNAS MLH1 CDKN2A GNA11 TMEM127 ESR1 IL2RG KRT1 MET NF2 SDHAF2 SDHD WT1 MAP3K8 STAT1 PHOX2B PTPRJ PTCH2 CHD7 TERT LMNA ERCC6 EDNRB XPA PDGFRA OFD1 VHL SAMD9L SF3B1 FERMT1 BRCA1 GDF2 CASP8 TP53 LAMC2 GFI1B FANCD2 PYGL CR2 AR REST APPL1 APC CYP2A6 SEMA3C WT1 CDKN2A CTSA LRRC8A PHOX2B SMARCB1 NAGS FLI1 SOX2 RAD21 TMEM127 APC FGF3 BAP1 BUB1 RAD51 DKC1 RAD54B VHL EPCAM ASXL1 SRC HRAS BMP2 SLC25A11 PTH1R KRAS MYD88 NPM1 PTEN SH3GL1 PHOX2B TP53 SMAD4 XPA GATA4 MLH1 PMS2 STK11 FANCC DHCR7 PTCH1 CDC73 CYLD MEN1 CLCNKB CHEK2 RNF139 HABP2 POLE H19-ICR MMP1 RPL27 CC2D2A PIK3CA GPC3 ABL1 PALLD WASHC5 INTU ERCC5 DYNC2LI1 SLC22A18 TP53 CDH1 SHH MPL AKT1 NFKB2 NRAS PIGL CASP8 MYC KCNE3 DLST TAF15 TNFRSF13B GDNF EYA1 APC2 TNFRSF1B TCTN3 PPOX PNP PKHD1 BLM ODC1 IL12A TERT STK11 KRT17 IDH1 CIB1 RPL18 DVL1 ARHGAP26 PHOX2B CASP8 RPGRIP1L KRT6A SDHB FGFR2 VAMP7 JAK2 SRY DNMT3A EPAS1 KCNQ1OT1 MSH6 KRAS SDHB WNT5A DNMT3A RUNX1 TRIM28 DHCR24 USB1 VANGL2 GCM2 LIG4 KRAS SDHB ENG SEMA3D TRNS2 MINPP1 CASP10 NTHL1 LMOD1 SUFU FOXH1 CD81 ALX4 F13B BMPR1B RB1 CACNA1S CHIC2 VHL HRAS KIF11 KCNJ11 WRN SLC37A4 GNAQ LZTR1 CCND1 CPLX1 NR4A3 RYR1 NBEAL2 GATA2 TP63 APC KRAS HNF1B SUFU GNB1 MSX2 GPC3 CEL TCTN3 OCA2 MDM4 RB1 TMC6 ASCL1 AR BRIP1 CHEK2 AAGAB TSC1 TXNRD2 POLD1 CARMIL2 APC PIK3CA AKT1 POLE FAN1 RAD21 G6PC BRD4 PTCH2 MSH2 DHH EWSR1 SPRTN SDHC PTCH1 ALX3 CD79A TMEM67 INPP5E CCBE1 KRT6B BRCA2 ITK GINS1 HLA-DRB1 SNAI2 NBN PHOX2B BRAF CDH1 FANCE TYR GPC4 NF1 CD19 MVD AIP AR NBN TMEM107 BRIP1 ATRX BCHE MITF WRN BCR BCR NF2 SERPINA1 SDHB RABL3 PARN ANTXR2 TERT DPM1 IFIH1 GDF5 ZAP70 MEN1 TP53 GNAS BRCA2 TMC8 NODAL LETM1 VANGL1 TBXT BRCA1 FIBP FLT4 IL1B CCL2 FGFR3 SUFU MTAP ELANE CD19 HNF4A SAMD9 BUB1B KLHDC8B SLC26A2 FGFR3 FOXP1 PUF60 RUNX1 PTCH2 TRNK FLT4 TYROBP MPL KRAS RAD54L PIK3CA FAH CHEK2 CPLANE1 FAM20C CXCR4 DDR2 POU6F2 TMC6 SEC23B RET TRNP TFE3 TP53 NAB2 ANTXR1 MYSM1 SDHAF2 BTK TNFRSF10B DCLRE1C L2HGDH CDKN2A CYP11B2 BRCA2 SDHD TET2 TMEM216 BRAF PTCH2 TCF3 RPL11 NNT FLT3 BAX HAX1 IGF2 AKT1 FGFR3 MLH3 PLA2G2A TCF4 MLH3 NOTCH1 ERCC4 RRAS2 GPC4 DICER1 LZTS1 DOCK8 CASP10 GREM1 HPGD COL1A1 DCLRE1C IDH1 XRCC3 SUFU DNAJC21 PDGFRB TP53 NLRP1 WWOX TSC1 CTSC USP9X PDCD10 MEN1 ASCL1 RNF43 TNFRSF13C ESCO2 ZFPM2 AP2S1 PRCC HMBS ADA2 GANAB WT1 RNF43 HRAS KRAS SETD2 ATP6V1B2 FLT3 TJP2 BMPR1A PDGFB KIAA0753 PTEN STK4 NFKB1 BAP1 PMS1 MSR1 SLC26A2 RECQL4 MSH2 JAK2 ATRX FH RECQL4 FCN3 CD28 ASPSCR1 ADAR WHCR NOTCH3 GATA2 SMARCE1 CDKN2A RET ESCO2 EXT1 ERCC5 TET2 MBTPS2 NF1 OFD1 AGGF1 MVK KIT MUTYH HRAS KRIT1 FGFR1 TRIM28 CHEK2 CD79B GNAS BRCA2 KDSR BAX HACE1 MAP2K2 EDN3 ERCC2 CTNNB1 IL6 IGH PIK3CA MSH3 FZD2 SMPD1 SNAI2 PHOX2B SLC26A2 OFD1 PAX4 RB1 TRIP13 EWSR1 SCN9A PIK3R1 GBA EP300 PIK3CA HMMR KIT PDE6D ZSWIM6 SH3KBP1 SRP54 FUZ USP8 WT1 TERT MAFA FOXO1 GJB3 RAD51D POT1 SDHC PRKAR1A CREB1 SH2D1A WIPF1 WWOX PIK3CA NF2 HNF4A FAS RNASEH2A CD27 ATRX SPRED1 RPS14 FDPS RNR1 PALB2 NF1 MN1 TET2 GPC4 KDR SOX9 RAD51 MAX MYLK EP300 SHOX FOXE1 TCOF1 ESCO2 MYH11 HSPA9 MAD2L2 KRT9 CYP2D6 RFWD3 FANCE KRAS CCND1 LMO1 PTCH1 PORCN EDN3 PDGFRA DICER1 FANCA TERC CTBP1 SDHD ANTXR1 CXCR4 RAD50 BRCA2 MC1R MPL SLC22A18 MMP1 KRT16 F13A1 TSC2 ENG SETBP1 WT1 TET2 SDHC SMAD4 ZFHX3 GFI1 RNF113A STK11 KARS1 FOXE1 CDKN2B WT1 ERBB3 SMARCAD1 PDGFRL DMPK GTF2H5 NF2 CEBPA RPS28 PMS1 AKT1 PRDM16 NBN GCK SPINK1 ERBB2 JAK2 KIT DKC1 EXT1 JAK2 COL7A1 AXIN1 SLC22A18 NRAS ECM1 GNPTAB ABCA5 CDH1 NRAS ERCC6 VANGL1 RAD51C MYCN HBB TP53 SRY FANCI AKT1 MITF LEMD3 TARS1 TET2 NSD2 DAXX DYNC2LI1 OGG1 EXT1 TNFSF15 TERT ERCC6 DMRT3 SLC25A11 CTNNB1 VHL KLLN MLH3 EIF2AK4 GJB6 BARD1 OCRL GPR35 MYC DLST KRAS MSH3 RMRP PRKCD KLF6 NEUROD1 FANCG SLC17A9 BMPER FLCN SDHC SF3B1 STS GNA14 TERC MNX1 CAT TCF4 TUBB TRNQ BRCA2 IL12RB1 PDX1 CDKN2A SLC26A4 SDHC PPM1D NRAS PRKAR1A NRAS TAL1 KIF1B DNMT3A PDGFB MRAP ERCC3 CDC73 PRF1 RFWD3 PMVK RPL15 FGFR1 TP53 BICC1 HNF1A GATA1 RTEL1 RPS15A ERCC4 WRAP53 NR0B1 BCR FGFR2 SEC23A KRT17 NR5A1 VHL BLM BRAF ICOS POLD1 RPS27 FASLG CYSLTR2 PTEN PRKN THPO KIF7 NRAS TAL2 BRAF WDPCP DCC MSH6 NOP10 WNT10A PSAP ERCC2 CALR ACD SLX4 ACAN HABP2 GJB4 TET2 PHF21A ERCC3 MDH2 APC PALB2 RPL10 KRT17 PGM3 IL7R ARL6IP6 APC TCIRG1 NF1 SMAD4 PTPN3 PIK3CA ABCA5 FGFR2 TGFBR2 BRCA2 HNF1A RNASEH2C PAX6 IGH TTC37 DICER1 SRY GPC6 TOP2A KIT OFD1 PALB2 NRAS MC1R SDHD TFAP2A FGFR3 TNFRSF1B REST PTEN MST1R SCN4A BRCA2 CDKN2A FGFR2 ZIC2 EFL1 ECE1 NUP214 DDB2 GPC3 KCNQ1 PTEN HNF1B FN1 ASCC1 SPIB SRP72 PTEN FANCB KCNJ10 AKT1 KRAS KEAP1 INS DISP1 PTEN SASH1 CDKN1C ACTB TNFRSF13B MYH8 EDN1 IVNS1ABP NSUN2 TSC1 RAD51C MSH3 ATP7B RET PTPN12 STIM1 DHCR7 KRAS SFTPC BMPR1A XPC TMC8 KCNJ10 KDM6B STK11 KRAS GNAQ KRAS HFE HOXD13 B3GALT6 RPL5 KAT6B GATA2 MUC5B PIK3CA USP8 GDNF SMAD4 MVK RHBDF2 SSX2 CEP57 RAD51C NEK9 JAK2 PDGFB NRAS KRT1 PIK3CA MFN2 DOCK8 PTEN IL7 SDHC ATM AKT1 BRCA1 RELA GCDH PIK3CA IDH2 HRAS CTLA4 GPR143 ERCC2 GATA2 PTPN11 IGF2 SMAD4 NDUFAF6 CDH23 RPS7 RAD54B TP53 MUTYH GLI3 PTPN11 BRIP1 CDKN1B SF3B1 PTCH1 CIB1 ERCC3 PTPN11 TRPV3 GDNF IGLL1 PRKCD CTNNB1 PIK3CA PTPN11 SLCO2A1 FAH BRCA1 ETV6 BRCA2 EPCAM TP53 EXT1 BCL10 TRPS1 BMPR1A ATM MPL KRT17 MAX SLC12A3 ADA TERT UBE2T TSC2 TCTN3 MSH2 BDNF BTK SKI RPS20 NRAS RUNX1 DCC MSH2 RPS24 WT1 TRNF TFAP2A RPL35 RPS17 SDHA RARA CDC73 SBDS POLH BRAF LAMB3 RNF6 PIEZO2 KCNQ1OT1 CCM2 PHKA2 POU2AF1 TP53 TREM2 ABCC8 EXT2 ALK PHKG2 NUTM1 SLC26A4 PTCH1 MUTYH PALLD NBN FANCA SQSTM1 ELMO2 ACP5 TWIST1 TRIM37 RPL31 HFE RET DLC1 SDHB EP300 TREX1 HSPG2 ATP7A MSH6 C2CD3 CHRNG SRP54 TINF2 BUB1 PSENEN SMAD4 NF1 ERCC3 ARID1B RMRP WAS GATA2 MAPK1 BIN1 COL7A1 EDN3 PIK3CA IGF2 H19-ICR TUBB FH MLH1 TNFSF12 PIK3R1 RASA1 F5 SH2B3 CTNNB1 FOXI1 SUFU TLR2 SRSF2 CDKN1B GJC2 OPCML LEMD3 FIBP TRNS1 HNF1A VHL PTEN PRKAR1A MSH2 CYLD CTHRC1 COL7A1 DDB2 SDHC GJB2 LIG4 MDM2 LAMA3 CHEK2 MTOR CDON SMARCE1 TAF1 GNAQ TP53 RAD54L WWOX BMPR1A CCND1 GFI1 BCL10 PTEN CTNNB1 DHX37 SLX4 FGF8 XRCC4 TRIP13 CDC73 BIRC3 NOTCH3 DIS3L2 PKD2 KIF1B GNA11 ARMC5 CREBBP DIS3L2 HRAS LMX1B BAP1 BRCA2 POT1 ABCB11 AURKA RASA1 SMARCB1 ALX4 GPC3 MGAT2 PAX3 IGHM LMNA TCF4 GATA1 TRNK IDH1 LRP5 CALR FH RET SEC23B APC TET2 SETBP1 WT1 PMS2 POLR1C SIX3 EPHB2 RPL35A RET TINF2 CD28 CYP26C1 MNX1 ALX3 KIT CPOX GJB2 DLL1 MSTO1 RSPO1 TEK EXT2 ABCC6 COL2A1 GNAS FH FASLG BAP1 COL14A1 YY1 RAG2 RB1CC1 MAP2K1 RHOH STAR CREBBP RECQL4 EVC2 HBB ERBB2 ABL1 NDP SUFU NF2 MSH6 ATP7A TSC1 FAS SLC6A17 MS4A1 NQO2 FLCN EXTL3 SOS1 RNASEL NPM1 KIT GNAI3 TRNH RAG1 HRAS BUB1B IGF2 PLAG1 FANCD2 BCL2 NEK1 KIT ATP7A PIK3CA SMARCB1 PCGF2 LIG4 BCL6 NUP214 FLNA IRF5 ACVR1 GAS1 DYNC2H1 RSPRY1 TRAF7 RNASEH2B REST RPS29 TGIF1 TERT PIGA TP53 CDK4 GPR101 ACVRL1 SAMHD1 MSL3 MAPRE2 SLC45A2 CTNNB1 ADA KLF11 NKX2-1 GLI2 PKD1 MAP3K1 SRP54 TNFSF12 ND5 CRKL RASGRP1 BCL10 RPS26 GLI3 TRNL1 AR SDHA RB1 MLH1 MC2R TGFBR1 KIT CYP11B1 AXIN2 EGFR PIK3CA RECQL4 EXOC6B SMO SFTPA2 NRAS CDKN1B TP53 PIK3CA MSH6 ACTG2 POT1 SDHB RNF6 CALR KCNN3 C11ORF95 TSC2 CD96 SOS1 COL2A1 SMAD7 GLI1 FANCF MPL CDH1 BRCA2 BRAF ATR SDHA FLCN DICER1 IL1RN ICOS AIP RSPO1 DICER1 GCM2 XRCC2 DNASE1L3 PPP2R1B TGFBR2 MTM1 CDKN2C SIX1 MEN1 POU6F2 SRD5A3 STAT3 ERCC3 TG ASXL1 CDKN2B CYLD NHP2 CCDC22 TBC1D24 BLNK DIS3L2 SH2B3 MPLKIP AHCY PCNA EXT2 EXT2 MEN1 PARN WRAP53 TP53 HBB GABRD NUMA1 APC ZSWIM6 BRCA1 GJB2 KCNAB2 AIP USF3 RUNX1 H19 HDAC4 SDHD UROD PDGFRB CR2 HRAS CDH1 ERBB2 TNPO3 LPP SDHD IL2RG ATM BARD1 TREX1 POLE C2CD3 ERCC4 SLC25A13 PNP KRAS SRSF2 SDHB FGFR3 CASR CASP10 TET2 CTC1 ENPP1 SOX6 PIK3CA BMPR1A ERCC2 TERC CBL ADAMTS3 PIGL BCR SAMD9L NOD2 CBL TGFBR2 MALT1 SEMA4A ANTXR2 SLC37A4 TBX2 DHH STS SDHB TERT KRT16 DZIP1L RTEL1 SDHD CCND1 AKT1 FOXI1 CDK4 NSD1 MLH1 FLCN DLEC1 FGFRL1 MTMR14 GCGR TBX18 CREBBP MXI1 APC BCL10 COL11A2 TERT MC1R SCN10A RPS10 SMO BRCA2 KIT ATM PRKN MRE11 KIF1B KCNH1 VHL GPR101 GNAS PMS2 ACD WDPCP MAD1L1

    Reports

    Data processed on September 26, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

    Drug Reports   MeSH Reports   HPO Reports  

    Interventions

    4,180 reports on interventions/drugs

    MeSH

    691 reports on MeSH terms

    HPO

    263 reports on HPO terms

    All Terms

    Alphabetical index of all Terms

    Google Colab

    Python example via Google Colab Notebook