CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

HP:0002664: NeoplasmHPO

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (37)

Name (Synonyms) Correlation
drug332 Best Practice Wiki 0.26
drug1326 Lazertinib Wiki 0.22
drug553 Chemotherapy Wiki 0.22
drug360 Biosensors Wiki 0.22
drug265 Azithromycin 250 MG Oral Capsule Wiki 0.22
drug1746 PT-PCR test for SARS-CoV-2 Wiki 0.22
drug169 Anatomic Pulmonary Resection Wiki 0.22
drug1673 Obvio-19 app Wiki 0.22
drug2066 Remain COVID Free SSI Wiki 0.22
drug762 Diet tracking and survey Wiki 0.22
drug631 Contain COVID Anxiety SSI Wiki 0.22
drug2895 modification of the planned therapeutic management Wiki 0.22
drug2418 TAK-981 Wiki 0.22
drug2686 Web-based REDCap survey Wiki 0.22
drug207 Aprepitant injectable emulsion Wiki 0.22
drug361 Biospecimen Collection Wiki 0.22
drug2095 Rintatolimod Wiki 0.22
drug2360 Stereotactic Radiotherapy Wiki 0.22
drug809 EHR-based Clinician Jumpstart Wiki 0.22
drug2038 Recombinant Interferon Alfa-2b Wiki 0.22
drug2153 SCH Intervention Wiki 0.22
drug2179 Saline Placebo Wiki 0.22
drug717 Data Collection Wiki 0.16
drug1269 Itraconazole Wiki 0.16
drug1828 Placebo Administration Wiki 0.16
drug2093 Rifampin Wiki 0.16
drug1316 LY3819253 Wiki 0.16
drug1979 Questionnaire Administration Wiki 0.16
drug1163 Ibrutinib Wiki 0.16
drug1108 Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki 0.13
drug1368 Lopinavir/Ritonavir Wiki 0.13
drug1852 Placebo oral capsule Wiki 0.13
drug2527 Tocilizumab Wiki 0.08
drug2326 Standard of care Wiki 0.05
drug1086 Hydroxychloroquine Wiki 0.04
drug1853 Placebo oral tablet Wiki 0.04
drug1822 Placebo Wiki 0.04

Correlated MeSH Terms (37)

Name (Synonyms) Correlation
D009369 Neoplasms, NIH 1.00
D019337 Hematologic Neoplasms NIH 0.25
D002583 Uterine Cervical Neoplasms NIH 0.22
D000741 Anemia, Aplastic NIH 0.22
D014594 Uterine Neoplasms NIH 0.22
D014625 Vaginal Neoplasms NIH 0.22
D010265 Paraproteinemias NIH 0.22
D008998 Monoclonal Gammopathy of Undetermined Significance NIH 0.22
D014846 Vulvar Neoplasms NIH 0.22
D008175 Lung Neoplasms NIH 0.22
D008218 Lymphocytosis NIH 0.22
D007676 Kidney Failure, Chronic NIH 0.18
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.16
D010051 Ovarian Neoplasms NIH 0.16
D009196 Myeloproliferative Disorders NIH 0.16
D014652 Vascular Diseases NIH 0.16
D016491 Peripheral Vascular Diseases NIH 0.16
D058729 Peripheral Arterial Disease NIH 0.13
D009190 Myelodysplastic Syndromes NIH 0.13
D009362 Neoplasm Metastasis NIH 0.13
D001943 Breast Neoplasms NIH 0.11
D051437 Renal Insufficiency, NIH 0.11
D003324 Coronary Artery Disease NIH 0.11
D008103 Liver Cirrhosis, NIH 0.11
D006333 Heart Failure NIH 0.08
D008173 Lung Diseases, Obstructive NIH 0.07
D017563 Lung Diseases, Interstitial NIH 0.07
D020521 Stroke NIH 0.07
D002908 Chronic Disease NIH 0.07
D008171 Lung Diseases, NIH 0.06
D007239 Infection NIH 0.05
D003141 Communicable Diseases NIH 0.04
D055371 Acute Lung Injury NIH 0.02
D012127 Respiratory Distress Syndrome, Newborn NIH 0.02
D012128 Respiratory Distress Syndrome, Adult NIH 0.02
D011014 Pneumonia NIH 0.01
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (23)

Name (Synonyms) Correlation
HP:0100650 Vaginal neoplasm HPO 0.22
HP:0030416 Vulvar neoplasm HPO 0.22
HP:0100827 Lymphocytosis HPO 0.22
HP:0030079 Cervix cancer HPO 0.22
HP:0012133 Erythroid hypoplasia HPO 0.22
HP:0010784 Uterine neoplasm HPO 0.22
HP:0100526 Neoplasm of the lung HPO 0.22
HP:0001909 Leukemia HPO 0.19
HP:0005547 Myeloproliferative disorder HPO 0.16
HP:0100615 Ovarian neoplasm HPO 0.16
HP:0006510 Chronic pulmonary obstruction HPO 0.16
HP:0002863 Myelodysplasia HPO 0.13
HP:0001677 Coronary artery atherosclerosis HPO 0.11
HP:0000083 Renal insufficiency HPO 0.11
HP:0001395 Hepatic fibrosis HPO 0.11
HP:0003002 Breast carcinoma HPO 0.11
HP:0004950 Peripheral arterial stenosis HPO 0.10
HP:0001635 Congestive heart failure HPO 0.08
HP:0006536 Pulmonary obstruction HPO 0.07
HP:0006515 Interstitial pneumonitis HPO 0.07
HP:0001297 Stroke HPO 0.07
HP:0002088 Abnormal lung morphology HPO 0.06
HP:0002090 Pneumonia HPO 0.01

There are 20 clinical trials

Clinical Trials

1 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 Lung Neoplasm Radiation: Stereotactic Radiotherapy Procedure: Anatomic Pulmonary Resection
MeSH:Lung Neoplasms 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

2 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 Neoplasms Lymphoma Hematologic Neoplasms Coronavirus Disease Drug: TAK-981 Drug: Standard of care
MeSH:Coronavirus Infections Hematologic Neoplasms 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, AUCāˆž: 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

3 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 Dementia Chronic Disease Neoplasm Metastasis Lung Neoplasm Pulmonary Disease, Chronic Obstructive Heart Failureļ¼ŒCongestive Liver Cirrhosis Kidney Failure, Chronic Lung Diseases, Interstitial Peripheral Vascular Disease Diabetes With End Organ Injury Palliative Care, Patient Care Health Care Quality, Access, and Evaluation Patient Care Inpatients Health Communication Patient Care Planning Behavioral: EHR-based Clinician Jumpstart
MeSH: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 Neoplasms
HPO:Abnormal lung morphology Chronic pulmonary obstruction Cirrhosis Congestive heart failure Hepatic fibrosis Interstitial pneumonitis Interstitial pulmonary abnormality Left ventricular dysfunction 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

4 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 we investigate the safety of chemotherapy for patients with gynecological malignancy in Wuhan, the center of high-risk regions of COVID-19.

NCT04341480 Gynecological Cancer 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

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

Description: Patient-reported outcomes are measured using the EORTC quality of life questionnaire core-30 (QLQ-C30).

Measure: Patient-reported outcomes

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

5 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 Gynecologic Cancer Breast Neoplasm Female Uterine Neoplasms Ovarian Neoplasms Uterine Cervical Neoplasms Vulvar Neoplasms Vaginal Neoplasms Other: modification of the planned therapeutic management
MeSH:Breast Neoplasms Ovarian Neoplasms Uterine C Uterine Cervical Neoplasms Uterine Neoplasms Vulvar Neoplasms Vaginal Neoplasms 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

6 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 SARS-CoV-2 Infection Hematological Malignancies
MeSH:Infection Hematologic Neoplasms 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 ā‰„ 30/min, SpO2 ā‰¤ 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 ā‰„ 30/min, SpO2 ā‰¤ 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

7 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 COVID-19 Invasive Malignancy (Any Type) 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

8 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 Cerebrovascular Accident Chronic Obstructive Pulmonary Disease Chronic Renal Failure Coronary Artery Disease Diabetes Mellitus Malignant Neoplasm SARS Coronavirus 2 Infection Other: Best Practice Biological: Tocilizumab
MeSH:Infection Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Stroke Kidney Failure, Chronic Coronary Artery Disease Neoplasms
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

9 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 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 transcriptionā€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

10 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 Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Pneumonia Pneumonitis Severe Acute Respiratory Distress Syndrome Symptomatic COVID-19 Infection Laboratory-Confirmed Biological: Tocilizumab
MeSH:Laboratory Infection Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Neoplasms
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

11 Phase 1/2A Study of Rintatolimod and IFN-Alpha Regimen in Cancer Patients With Mild or Moderate COVID-19 Infection

This phase I/IIa trial studies the side effects of rintatolimod and interferon (IFN) 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 Malignant Neoplasm SARS Coronavirus 2 Infection Biological: Recombinant Interferon Alfa-2b 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 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

Measure: Reduction of progression of infection requiring hospitalization

Time: Up to 30 days post treatment initiation

Description: ARDS will be defined by Berlin criteria.

Measure: Reduction of acute respiratory distress syndrome (ARDS)

Time: Up to 30 days post treatment initiation

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

Secondary Outcomes

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

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

Time: During the course of treatment up to day 28

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 28

Other Outcomes

Measure: ARDS severity

Time: Up to 30 days post treatment initiation

12 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 Myeloproliferative Neoplasm COVID
MeSH:Myeloproliferative Disorders Neoplasms
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

13 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 Asymptomatic COVID-19 Infection Laboratory-Confirmed Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Symptomatic COVID-19 Infection Laboratory-Confirmed Procedure: Biospecimen Collection Other: Data Collection
MeSH:Infection Communicable Diseases Laboratory Infection 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 subgroups of 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

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

14 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 COVID19 Hematologic Malignancy Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil] Drug: Azithromycin 250 MG Oral Capsule Drug: Placebo oral tablet Drug: Placebo oral capsule
MeSH:Hematologic Neoplasms 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

15 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 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

16 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 SARS-CoV-2 Oncology Surgery 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

17 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 Oncology COVID-19 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

18 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 Aplastic Anemia Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Monoclonal B-Cell Lymphocytosis Monoclonal Gammopathy of Undetermined Significance Myelodysplastic Syndrome Symptomatic COVID-19 Infection Laboratory-Confirmed Other: Best Practice Drug: Ibrutinib
MeSH:Laboratory Infection Myelodysplastic Syndromes Anemia, Aplastic Paraproteinemias Monoclonal Gammopathy of Undetermined Significance Lymphocytosis Neoplasms
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

19 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 Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Symptomatic COVID-19 Infection Laboratory-Confirmed Drug: Lopinavir/Ritonavir Drug: Placebo Administration Other: Questionnaire Administration
MeSH:Laboratory Infection Neoplasms
HPO:Neoplasm

Primary Outcomes

Description: 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

20 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 Oncology 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.

HPO Nodes

HP:0002664: Neoplasm
Genes 1515
EPCAM BAP1 CYLD WT1 CTBP1 GLI3 CTNNB1 ELMO2 ATRX TERT EDN3 MTAP TSC2 RAD51 BLNK KCNAB2 WDPCP SPINK1 ARID1B PTEN STK11 XPA PTH1R TCF4 EPCAM NF1 GPC3 ERCC3 MC1R CASP10 PDGFRA RPL5 CDH1 BRIP1 RUNX1 KRAS SFTPC GPR35 MYLK STS DYNC2LI1 RAG2 CBL FOXE1 STAT3 TTC37 ABL1 NSD1 ATM KCNH1 GPR101 IGH KRT17 SUFU TERT KRAS GPC3 CYP11B2 MLH3 PTCH1 FAH MSH2 EXT1 CCND1 MSH3 ATP7A SEC23A PHOX2B HAX1 MYD88 LMO1 PIK3CA PRLR AXIN1 TCF4 RUNX1 AKT1 ERBB2 REST DCLRE1C SERPINA1 ERCC3 TMC6 RASA1 MSH3 TRNL1 CALR HRAS INS RNF113A SETBP1 CDH1 SLC37A4 TFAP2A CDH1 PTCH1 KIT PTEN IL1RN MLH3 MUTYH PTEN KIT GBA BCL2 KCNH1 GINS1 ESCO2 TET2 SLX4 DICER1 PALB2 NEK1 ESCO2 COL7A1 PTCH2 WT1 WRN GCM2 BRD4 BRAF TREX1 THPO SUFU NRAS CDC73 POU6F2 GNAS DAXX BUB3 RSPO1 MNX1 ERCC2 RPS28 ANTXR2 CTNNB1 POT1 FANCA KDM6B RET MST1 NOTCH3 FGFR1 KRAS LYST CHIC2 TMC6 MET KRT10 UROD SLC25A11 ARSA EVC2 TEK XRCC2 CASP8 ASCL1 IL1B TERF2IP DICER1 MPL OFD1 RHBDF2 DICER1 MDM2 WT1 MMP1 CDKN2A FGF8 NR4A3 FGFR2 OCRL TP53 ERCC2 SUFU ERCC4 ALX4 TINF2 DCLRE1C SRY SRP72 NF2 GNAS LETM1 TP53 FANCB TAL1 TDGF1 BRCA1 LEMD3 NF2 BRAF NUP214 RAD21 COL18A1 SDHD ICOS CEP57 BAP1 FANCM PTPRJ FANCE SLC22A18 PIK3R1 JAK2 FLT4 SMO WIPF1 DLST NF2 RAD50 MEN1 CHEK2 GPC4 WDPCP CYP2A6 HBB GANAB XRCC4 TET2 ATP7B EP300 DIS3L2 HFE CARD14 OFD1 ALX3 VANGL1 BAP1 SDHB EXTL3 PIK3CA GATA2 ALX3 BCL10 KIT WAS FGFR2 RMRP TWIST1 BMPR1B DIS3L2 ERCC3 FOXP1 SMAD4 CALR APC PCGF2 USP8 DMPK NRAS DKC1 BRCA1 ADAR BCR RSPO1 SLC45A2 GJC2 TNFRSF4 AKT1 IFIH1 MSH6 DICER1 PAX6 TGFBR2 SRY KLHDC8B CPLX1 MSH6 AIP PMS1 CREBBP ERCC2 CTSA APC MMP1 SH2B3 PKD1 TRNF SEC23B DNAJC21 STK11 BCR HBB MITF IGLL1 ALX4 MDH2 AKT1 SCN4A SDHAF2 PRKN PLA2G2A RNF43 DNMT3A TERT NSD2 RMRP FANCG BRCA2 CAT TP53 BMPR1A MAD2L2 SIX6 DDB2 GREM1 KRT17 PAX4 RPS17 TRPV3 ERCC4 C11ORF95 APC IL12RB1 BRIP1 PPM1D SDHB NODAL HNF1A FLT4 MSH6 ERCC6 BTK SLC26A4 SEMA3C AR NEK1 TERC RPL35A RPS20 CDKN1C SF3B1 TERC PTEN RFWD3 BRCA2 KCNQ1OT1 RPL10 ACTG2 MAGT1 ALK BLM H19 LEMD3 RPL31 MLLT10 PYGL RPL15 IRF1 CR2 MITF PTEN MYC PTPN11 TUBB TCF4 KCNQ1 NFKB2 ALX1 HLA-DRB1 APC EWSR1 NBN CDKN2A ERCC4 GCK DLL1 SLC25A11 PDGFB L2HGDH PRKCD CTC1 PIK3CA SUFU RPL27 KIF1B SRC CIB1 RECQL4 CDKN2B MSH3 BRCA2 PALB2 PDE6D SDHC SDHD CCL2 CHEK2 PMVK XPC STK11 PIK3CA MVD DHCR7 KIT GPC6 KARS1 MNX1 VHL TUBB NAB2 KEAP1 TSC1 NQO2 APC SDHB VHL TCTN3 RECQL4 PMS2 RAD51C STAG3 SNAI2 MAP3K8 SETBP1 SDHB NPM1 RAD51C RARA ERBB2 ERCC5 ATRX CHEK2 KRAS BRCA1 TFAP2A SLCO2A1 PHOX2B PTEN COL2A1 PIGL PDGFRA APC CPLANE1 AURKA SDHD LAMA3 VHL RPS26 GFI1B CDKN1B PRDM16 AXIN2 FZD2 AP2S1 LZTR1 TP53 TP53 GNA14 CTNNB1 MSTO1 PIK3CA RPS29 CALR DHX37 MYF6 SDHC MALT1 ELANE SDHD SLC26A4 MAP3K1 GDNF MSH2 SDHC TGFBR1 RUNX1 CREB1 CDKN2A TSC2 KRAS TNFRSF10B LMNA WWOX PHOX2B EDN3 RPS10 RSPRY1 TRIM37 RET MEN1 BCL10 MSH2 TNFRSF13C FOXE1 FANCC H19-ICR BLM ERCC6 LIG4 BDNF LMOD1 NF2 TMEM107 CYLD GJB2 EXT1 CTSC PHOX2B RAD51D RASGRP1 RB1 TGFBR2 SRY MYH8 KRAS TINF2 RECQL4 H19 PRF1 GDNF MXI1 SMPD1 WT1 HRAS COL1A1 PDGFRB FAS FANCD2 NF1 DISP1 PDGFRL IKBKG BIN1 BRCA2 ADA POLE AXIN2 SEMA4A KRAS NRAS PALB2 CHEK2 ASCL1 POLE TLR2 PIK3CA MINPP1 SOS1 CYLD CTLA4 POT1 ASXL1 CDC73 APC SAMD9L WT1 TRAF7 GATA4 PIK3CA DYNC2LI1 ATP7A CBFB MST1R GCGR MPL COL4A5 SMAD4 CDKN1A SDHD TRIM28 POLH GPR101 PIK3CA FLCN GPR143 RB1 SBDS SLC12A3 KLF6 ICOS GNB1 PIGA TYROBP GFI1 RAD51 SLC26A2 MC1R TREM2 SFTPA2 JAG1 BAP1 EGFR IGH KIT PLCB4 NLRP1 HNF1B ZFHX3 EPHB2 KLLN OCA2 WT1 FAH FH TERT SRD5A3 LIG4 NFKB1 RNF43 KIT STAT1 IFNG BMPR1A ERCC3 TBX18 TET2 MAP2K1 EXT2 HRAS RTEL1 FGFR3 PTEN CTNNB1 MAP2K2 MEN1 APC CLCNKB AKT1 ESCO2 CDC73 MS4A1 BRAF CRKL NUTM1 CDK4 NTHL1 ETV6 TET2 SQSTM1 FAM20C PIGL SEC23A ATM PALB2 TYR SRSF2 EXT2 GJB2 DNMT3A HRAS TCOF1 CHEK2 CDH1 FH DKC1 POLE PIK3CA PTCH2 AKT1 PAX3 FH ADAMTS3 APC PMS1 RAD51C PLCD1 PUF60 DIS3L2 CDH23 SCN9A FOXC2 SMARCB1 CDKN2A VANGL2 ENG SH2D1A SDHB SOX9 BRAF SDHA PGM3 ERCC2 GJB2 TBC1D24 CHD7 MPL DHH PTCH1 CALR IL12A TNFRSF13B CD28 MLH1 PTPN12 OFD1 MLH3 REST CCDC22 APPL1 COL14A1 IGH PSENEN IL2RG MC1R SMARCA4 CYLD KIF11 PHKG2 JAK2 COL2A1 AXIN2 FLNA WNT5A TYR EP300 GLI3 EXT2 MGAT2 KCNE3 ECE1 PARN IDH2 TSC1 ARL6IP6 FGFR3 SMAD4 HMBS SLC6A17 PRKAR1A BAP1 KDSR DHCR24 CXCR4 DDX41 GABRD RET NR0B1 DMRT3 CCND1 GDF5 POU6F2 CTLA4 TBXT FANCA NRTN PHKA2 KIT ITK RNASEH2A PERP CDC73 OFD1 CYP2D6 RET MEN1 CD27 PARN FUZ RPS19 MSH2 SMARCE1 TNFSF12 ZSWIM6 TERT RHOH NF1 BUB1B SLX4 LIG4 PDGFRL TNFSF15 OPCML APC PRKCD SETD2 RPS19 BRCA1 FAT4 ANTXR1 WNT10A SUFU TP63 EFL1 IL7 MN1 DOCK8 CDC73 SSX1 TMEM231 MPLKIP VHL MINPP1 BIRC3 PDX1 STS PSAP HNF1A JAK2 FANCL POT1 GNAS TERT CD79A KLF11 WRN MAPRE2 LIG4 CYSLTR2 DNM2 SH3GL1 KIT FOXH1 RELA KRAS PRKAR1A ERBB3 FGFR2 H19 TJP2 CD81 PNP MSH6 WT1 THPO ATP6V1B2 GNAQ BRCA1 WRAP53 ERCC3 CHRNG KRT14 TSC1 DLC1 CTNNB1 FGFRL1 SDHC GDNF HABP2 NRAS ATR TRNK BMPR1A TERT BRAF AKT1 XPC FGFR3 NUP214 TRIP13 SMARCD2 ZSWIM6 PIEZO2 EVC IL6 HRAS GPC4 TNFRSF13B PALLD CDKN2A POLR1D TP53 FOXO1 BRCA2 FIBP CDH23 RB1CC1 B3GALT6 FLT3 GJA1 SH2B3 MRAP MTOR AR FOXI1 TP53 GNAQ KRT6B MYD88 KRT16 TP53 NF1 MYSM1 MGMT KIT NF1 GPC4 GCM2 SIX3 PIK3CA RAD21 HRAS PMS2 ASCC1 BRCA2 GAS1 FASLG SDHD NRAS C2CD3 KDR SDHA SMAD4 SOX2 NBEAL2 SRGAP1 AGGF1 ATM AKT1 RPGRIP1L NOD2 BAX BRCA2 H19-ICR TGIF1 MAPK1 ESR1 EXT1 RPL11 KRAS BCL10 SKI LAMB3 XIAP SDHC HABP2 TRNS1 CCM2 FIBP PIK3CA TRIM28 HRAS SCN10A NF1 WT1 CPLANE1 HFE F5 C2CD3 GNPTAB TBX2 KLF6 GATA2 VEGFC RNASEH2B CBL SEMA3D ARMC5 CXCR4 JAK2 IGF2 FGFR2 NRAS UBE2T ARHGAP26 SCN11A MEN1 LMX1B F13A1 BCR COMP EDN1 SDHC ACTB GDNF CDKN2C ASPSCR1 NAGS PDGFRB PALB2 DLEC1 BCL10 STAR GNA11 PORCN RNR1 FLCN SPIB WT1 RET SDHB SLC22A18 ERCC4 CDKN2A CTHRC1 DLST OGG1 POLD1 DCC IL2RG REST SRP54 RAF1 TSC1 SRP54 IDH1 ACD KIT ACAN NSD2 TOP2A CASP10 DVL1 PTPN11 CASP10 STIM1 KRT9 AR CIB1 GNAS AR VAMP7 MRE11 GFI1 RPS14 BCL10 CACNA1S TP53 VANGL1 SKIV2L PTCH2 G6PC LRP5 PDGFRB BARD1 RPS27 RPS7 GNAS ENPP1 STAT6 ACVR1 MTM1 NEUROD1 TNFRSF13C PKD2 RUNX1 STK11 FGF3 TRIP13 SIX1 BRCA2 LAMC2 NELFA DVL3 GJB4 NSUN2 CDKN1B CTNNB1 POLR1C GJB3 SMARCB1 SBDS LMNA KRAS TRNH ECM1 STK4 ANTXR2 SOS1 BAP1 MSX2 DICER1 SDHB ACD WRAP53 BRCA1 ATP7A BUB1B RYR1 RET BRCA2 TP53 DPM1 BRCA2 BCR POLD1 TCIRG1 PTPN11 HOXD13 CR2 TARS1 JAK2 BMP2 MUTYH FLT3 TRNS2 MTMR14 NR5A1 ABCA5 RET AHCY TSC2 KIT KCNQ1OT1 RNF6 RAD54L HNF1A HMMR RNF139 WWOX TCTN3 BRAF FCN3 RNASEH2C AIP PRKN SF3B1 MSH6 NSD1 PTCH2 CCBE1 RECQL4 PMS2 ERCC2 HNF4A MMEL1 BUB1 TET2 TRPS1 ABCC6 RET IRF5 CDKN2B PDGFB USP9X TAL2 INTU GNAS HDAC4 MFN2 DYNC2H1 PIK3CA PLAG1 ATM MAX FAS PIK3CA CYP11B1 CCND1 H19-ICR PTCH1 MUTYH ABL1 ODC1 FGFR2 COL7A1 MSR1 BRCA1 RB1 TNFRSF1B COL7A1 FLT4 GPC3 TGFBR2 ATRX RAG1 PRCC BRAF TNFRSF1B FANCE RAD54L CBL SDHB TERT SDHD RPS24 FASLG MET KRT17 GATA1 ERBB2 FGFR1 KAT6B ABCA5 SDHAF2 SLC25A13 NOP10 GATA2 RFWD3 PDGFRA SPRTN MLH1 NKX2-1 IGF2R CD19 MAP3K1 TREX1 TRNP ZFPM2 CTNNB1 TRNQ WWOX IGHM MYH11 TMEM127 CDON NF2 SAMD9 PTEN RNASEL IDH2 HNF4A GTF2H5 GLI3 HRAS LPP DDB2 KIT PIK3CA PDCD10 HSPG2 HFE RPL26 BRIP1 ASXL1 SDHD CEBPA ACVRL1 NRAS CD19 GNAQ TET2 TCTN3 SMARCB1 FLCN ABCB11 BLK RAD54B SDHC FH AKT1 ANTXR1 FANCF HNF1B EXOC6B SAMHD1 SHOX MYO1H COL11A2 KCNJ10 TRIP13 CC2D2A LZTS1 SEC23B GPR101 DOCK8 BRCA2 NBN SLC26A2 SPRED1 VHL KRT1 LIN28B GTF2E2 NRAS ZIC2 SNAI2 SH3KBP1 SHOX BCL6 NTHL1 RHBDF2 CD28 MCM4 CCND1 FANCG SMARCAD1 GATA2 RERE YY1 ASXL1 IL7R TMEM67 C1S TAF1 FGFR3 NBN KRAS KIF1B AIP KCNJ11 LETM1 FANCI MLH1 MBTPS2 NRAS NEK9 GNAI3 APC2 EYA1 ZAP70 EXT2 BUB1 SSX2 LIG4 CARMIL2 SLC17A9 TMC8 PCNA EPAS1 TFE3 BRCA2 DHH MAP2K1 CASP8 CDK4 PDGFB RTEL1 EWSR1 PTEN VHL GJB6 NDP RNF6 TNPO3 TGFBR2 TXNRD2 PNP TAF15 TRNK SMO NOTCH1 LRRC8A RASA1 TSC2 ABCC8 PRKAR1A BAX IDH1 SLC22A18 ADA FAN1 TG PTEN BMPR1A MSTO1 ERCC5 IRF1 MLH1 NRAS MLH1 PICALM FANCD2 SF3B1 BICC1 RPS15A TERT KLLN ELANE FAM149B1 GATA1 SASH1 INPP5E TP53 WT1 BMPR1A PTPN11 PTPN11 MYCN XPA EDNRB TP53 FLI1 GDF2 PHB BMPER FGFR3 PTEN MCC EXT1 MC2R KCNN3 DNASE1L3 DHCR7 RASGRP1 SHH NPM1 SLC26A2 SLC37A4 IGF2 RPL18 SH2B3 PTCH1 BRAF PAX7 INHBA BMPR1A KIF7 XRCC3 IGF2 POU2AF1 DNAJC21 CYP26C1 RB1 MPL REST KIAA0753 DNMT3A ERCC6 MUC5B MLH3 ASXL1 MPL NOTCH3 KCNJ10 SMARCE1 TSR2 RPL10 KRT1 SLC25A13 WT1 NNT TP53 GNA11 GLI1 BARD1 FLCN COL7A1 SRP54 GLI2 EDN3 PTPN3 WT1 TMEM127 CD79B GATA2 TERC FN1 EIF2AK4 RAD51 WASHC5 SAMD9L AIP TP53 AAGAB RB1 TP53 KRT5 ADA2 HSPA9 PIK3CA SRSF2 PHF21A IDH1 KRAS KRAS CHEK2 BUB1B RET FANCC TP53 WHCR RAD54B NUMA1 SDHB HMBS TMEM216 SMAD4 MAFA MSH2 RPL35 CDKN1B IGF2 PPP2R1B CD70 CEL MAD1L1 MAX ALK GPC3 FERMT1 KIF1B TCF3 POLH PIK3R1 USF3 FDPS MYC DNAJC21 TNFSF12 HACE1 CDH1 SDHA ND5 NHP2 PIK3CA RPS14 NBN WNT10A ING1 CASR SUFU FGFR3 HPGD BTK ENG DCC CASP8 PHOX2B STAC3 USB1 KRIT1 PHOX2B TET2 SMAD4 JAK2 BCHE APC MVK SMAD7 SMO DKC1 SMARCB1 VHL F13B TINF2 USP8 FGFR1 FOXI1 TET2 CD96 TET2 JAK2 KRAS
Protein Mutations 75
C10D C377T C677T C797S D816V D835V D842V E10A E17K E542K E545K F1174L F31I G12C G12D G12V G13D G156A G20210A G719A G719C H1047R H1112L H1112Y H1124D K652E L1213V L265P L858R L861Q M1149T M1268T P1009S P13K P1446A P286R P4503A Q12H Q21D R132C R132G R132H R132L R132S R132V R140L R140Q R140W R172G R172K R172M R172S R172W R988C T1010I T1191I T315I T790M V1110L V1206L V1238I V411L V57I V600D V600E V600K V600M V600R V617F V941L Y1248C Y1248D Y1248H Y1253D Y842C
SNP 8
rs1045642 rs11615 rs13181 rs1695 rs25487 rs34489327 rs34743033 rs619824