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Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
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drug2672 | Quality-of-Life Assessment Wiki | 0.28 |
drug2687 | Questionnaire Administration Wiki | 0.27 |
drug415 | Best Practice Wiki | 0.25 |
Name (Synonyms) | Correlation | |
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drug2409 | Peripheral venous ultrasound Wiki | 0.19 |
drug338 | Azithromycin 250 MG Oral Capsule Wiki | 0.19 |
drug3333 | Therapeutic Exercise and Education Wiki | 0.19 |
drug2828 | Rintatolimod Wiki | 0.19 |
drug3022 | Serology SARS-CoV2 Wiki | 0.19 |
drug2469 | Placebo Administration Wiki | 0.19 |
drug2670 | Quality of life assessment Wiki | 0.19 |
drug2252 | Obvio-19 app Wiki | 0.19 |
drug2911 | SCH Intervention Wiki | 0.19 |
drug1686 | Intubation Box Wiki | 0.19 |
drug614 | COVID-19 diagnostic test Wiki | 0.19 |
drug2759 | Recombinant Interferon Alfa-2b Wiki | 0.19 |
drug3603 | Web-based REDCap survey Wiki | 0.19 |
drug170 | Aerosol Box Wiki | 0.19 |
drug2353 | PT-PCR test for SARS-CoV-2 Wiki | 0.19 |
drug3248 | TAK-981 Wiki | 0.19 |
drug3877 | modification of the planned therapeutic management Wiki | 0.19 |
drug729 | Chemotherapy Wiki | 0.19 |
drug1274 | Fenofibrate Wiki | 0.19 |
drug3219 | Survey Administration Wiki | 0.19 |
drug1293 | Flow cytometric analysis Wiki | 0.13 |
drug1768 | Leflunomide Wiki | 0.13 |
drug967 | Data Collection Wiki | 0.13 |
drug1497 | Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki | 0.13 |
drug2512 | Placebo oral capsule Wiki | 0.11 |
drug3505 | Usual care Wiki | 0.11 |
drug1566 | Ibrutinib Wiki | 0.11 |
drug377 | BNT162b2 Wiki | 0.09 |
drug453 | Biospecimen Collection Wiki | 0.09 |
drug1818 | Lopinavir/Ritonavir Wiki | 0.09 |
drug969 | Data collection Wiki | 0.08 |
drug3976 | questionnaire Wiki | 0.06 |
drug3375 | Tocilizumab Wiki | 0.06 |
drug3146 | Standard of care Wiki | 0.04 |
drug2514 | Placebo oral tablet Wiki | 0.03 |
drug2448 | Placebo Wiki | 0.02 |
Name (Synonyms) | Correlation | |
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D009369 | Neoplasms, NIH | 0.98 |
D019337 | Hematologic Neoplasms NIH | 0.28 |
D010051 | Ovarian Neoplasms NIH | 0.19 |
Name (Synonyms) | Correlation | |
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D000741 | Anemia, Aplastic NIH | 0.19 |
D014594 | Uterine Neoplasms NIH | 0.19 |
D014625 | Vaginal Neoplasms NIH | 0.19 |
D010265 | Paraproteinemias NIH | 0.19 |
D008998 | Monoclonal Gammopathy of Undetermined Significance NIH | 0.19 |
D014846 | Vulvar Neoplasms NIH | 0.19 |
D008218 | Lymphocytosis NIH | 0.19 |
D002583 | Uterine Cervical Neoplasms NIH | 0.13 |
D009190 | Myelodysplastic Syndromes NIH | 0.13 |
D009196 | Myeloproliferative Disorders NIH | 0.11 |
D003324 | Coronary Artery Disease NIH | 0.09 |
D001943 | Breast Neoplasms NIH | 0.08 |
D007676 | Kidney Failure, Chronic NIH | 0.08 |
D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.08 |
D008173 | Lung Diseases, Obstructive NIH | 0.07 |
D020521 | Stroke NIH | 0.05 |
D013923 | Thromboembolism NIH | 0.04 |
D007239 | Infection NIH | 0.03 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.02 |
D055371 | Acute Lung Injury NIH | 0.02 |
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 |
Name (Synonyms) | Correlation | |
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HP:0001909 | Leukemia HPO | 0.23 |
HP:0100650 | Vaginal neoplasm HPO | 0.19 |
HP:0030416 | Vulvar neoplasm HPO | 0.19 |
Name (Synonyms) | Correlation | |
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HP:0100827 | Lymphocytosis HPO | 0.19 |
HP:0012133 | Erythroid hypoplasia HPO | 0.19 |
HP:0100615 | Ovarian neoplasm HPO | 0.19 |
HP:0010784 | Uterine neoplasm HPO | 0.19 |
HP:0002863 | Myelodysplasia HPO | 0.19 |
HP:0005547 | Myeloproliferative disorder HPO | 0.13 |
HP:0030079 | Cervix cancer HPO | 0.13 |
HP:0001677 | Coronary artery atherosclerosis HPO | 0.09 |
HP:0003002 | Breast carcinoma HPO | 0.08 |
HP:0006510 | Chronic pulmonary obstruction HPO | 0.08 |
HP:0006536 | Pulmonary obstruction HPO | 0.07 |
HP:0001297 | Stroke HPO | 0.05 |
HP:0001907 | Thromboembolism HPO | 0.04 |
HP:0002090 | Pneumonia HPO | 0.01 |
Navigate: Correlations HPO
There are 29 clinical trials
The primary objective of this study is to determine the safety and tolerability of TAK-981 as a single agent in participants with advanced or metastatic solid tumors and lymphomas in Phase 1, to evaluate preliminary efficacy of TAK-981 in participants with select solid tumors or relapsed/refractory CD20-positive (CD20+) non-hodgkin lymphoma (NHL) indications in Phase 2, and to assess change in severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) viral load within 8 days of TAK-981 administration in COVID-19 Expansion.
Description: Severity grade will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, except for Cytokine Release Syndrome (CRS), which will be assessed by American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.
Measure: Phase 1: Number of Participants Based on Severity of TEAEs Time: Up to 48 monthsDescription: ORR is defined as percentage of participants who achieve complete response (CR) and partial response (PR), 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 or Lugano classification for lymphoma.
Measure: Phase 2: Overall Response Rate (ORR) Time: From the first dose until best response is achieved (up to 4 years)Description: Severity grade will be evaluated as per the NCI CTCAE Version 5.0, except for CRS, which will be assessed by ASTCT consensus grading criteria.
Measure: Phase 2: Number of Participants Based on Severity of TEAEs Time: Up to 48 monthsDescription: ORR is defined as percentage of participants who achieve CR and PR through the study (approximately 4 years), as determined by the investigator according to the RECIST V1.1 for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: ORR Time: From the first dose until best response is achieved (up to 4 years)Description: DOR is the time from the date of first documentation of a PR or better to the date of first documentation of progressive disease for responders (PR or better) and will be determined by the investigator according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: 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 4 years)Description: DCR is defined as the percentage of participants who achieve stable disease (SD) or better (determined by the investigator according to RECIST v1.1 criteria for solid tumors or Lugano classification for lymphoma) greater than (>) 6 weeks during the study in the response-evaluable population.
Measure: Phase 2: Disease Control Rate (DCR) Time: From the first dose until best response is achieved (up to 4 years)Description: TTR is defined as the time from the date of first study drug administration to the date of first documented PR or better by the investigator for responders according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: Time to Response (TTR) Time: From the date of first study drug administration to the date of first documented PR or better (up to 4 years)Description: TTP is defined as the time from the date of the first dose administration to the date of first documented progressive disease and will be determined by the investigator according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: Time to Progression (TTP) Time: From the date of first study drug administration to the date of first documented PD (up to 4 years)Description: PFS is defined as the time from the date of the first dose administration to the date of first documentation of progressive disease or death due to any cause, whichever occurs first and will be determined by the investigator according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: 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 4 years)Description: OS is defined as the time from the date of the first dose administration to the date of death.
Measure: Phase 2: Overall Survival (OS) Time: From the date of first study drug administration to the date of death (up to 4 years)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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsA 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.
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.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.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.
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 OThis 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.
Description: The percentage of HM patients with COVID-19 who died.
Measure: To evaluate mortality. Time: At 2 months from study initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 initiationIn 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.
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 monthsThis 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.
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 daysDescription: 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 randomizationDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsEVIDENCE 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.
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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsThis 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.
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.
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 intiationDescription: 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 initiationDescription: 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 30Description: 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 30Description: 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 initiationDescription: Rate of hospitalization due to infection
Measure: Hospitalization due to infection Time: Up to 30 days post treatment initiationDescription: 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 initiationDescription: ARDS will be defined by Berlin criteria
Measure: acute respiratory distress syndrome (ARDS) Time: Up to 30 days post treatment initiationDescription: Need for mechanical ventilation
Measure: respiratory failure requiring mechanical ventilation Time: up to 30 days post treatment initiationAn 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.
Description: Incidence of cases of MPN patients with COVID-19 experiencing pulmonary embolism
Measure: pulmonary embolism (PE) Time: 2 and a half monthsDescription: 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 monthsDescription: 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 monthsDescription: Incidence of cases reporting at least one COVID-19 worsening outcome as invasive ventilation
Measure: invasive ventilation Time: 2 and a half monthsDescription: 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 monthsDescription: incidence of death
Measure: death Time: 2 and a half monthsDescription: 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 monthsDescription: Type of treatments and interventions applied for COVID-19
Measure: treatments and interventions applied for COVID-19 Time: 2 and a half monthsDescription: 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 monthsThis 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.
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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsThe 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.
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 treatmentDescription: 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 monthsDescription: 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 monthsDescription: Date and cause of death
Measure: Mortality Time: up to 1 and 3 monthsDescription: 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 10Description: 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 monthsDescription: Collection of serum to realize serological tests
Measure: Evaluation of the seroconversion Time: at inclusion, day 10, day 30 and day 90 after treatmentDescription: 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 treatmentDescription: Duration of hospitalisation (conventional, intensive care, reanimation)
Measure: Hospitalisation duration Time: up to 3 monthsDescription: 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 monthsDescription: ECG (using connected machine to allow monitoring at home)
Measure: Monitoring of the QT space Time: at inclusion, day 2, day 5, day 10Description: Dosage of residual concentration of azithromycine and hydroxychloroquine.
Measure: Dosage of residual concentration of azithromycine and hydroxychloroquine. Time: at day 5 and day 10Description: 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 treatmentIn 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.
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 weeksTo evaluate the incidence of patients with a positive test for SARS-CoV-2, performed in the preoperative screening for patients treated at the institution
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 2020Description: 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 daysDescription: Postoperative complications will be recorded, according to the Clavien-Dindo classification.
Measure: Postoperative complications Time: Up to 30 daysDescription: To evaluate the risk of all-cause mortality
Measure: Mortality Time: 30 daysDescription: Assess the impact of delayed cancer treatment
Measure: Delay in the cancer treatment Time: May 2020- March 2021This 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.
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 monthsDescription: 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 monthsDescription: 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 monthsThis 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.
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 registrationDescription: 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 daysDescription: 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 daysDescription: 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 monthsDescription: 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 daysDescription: 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 monthsDescription: 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 monthsThis 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.
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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsThis 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.
Description: Retrospective chart review of health care utilization of both groups
Measure: Health Care Utilization Comparison Time: 5 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: Hospital Anxiety and Depression Scale (HADS) measurement of psychological distress in non-psychiatric patients.
Measure: Patient Anxiety/Depression Time: Monthly 5 monthsDescription: 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 baselineDescription: 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.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.
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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsThis 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.
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 treatmentDescription: Will be based on the assessment of dose limiting toxicity (DLT).
Measure: Maximum tolerated dose (MTD) (Phase 1) Time: During the 28-day treatment periodDescription: 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 28Description: 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 daysDescription: Defined as time from start of treatment to death from any cause
Measure: Overall Survival Time: Up to 90 daysDescription: Time from start of treatment to peripheral capillary oxygen saturation (SpO2) > 93% on room air
Measure: Oxygen Saturation improvement Time: Up to 90 daysDescription: 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 daysDescription: Hospitalized within first 90 days following start of treatment assessed as yes/no
Measure: Hospitalization Time: Up to 90 daysDescription: 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 daysDescription: If the subject required mechanical ventilation, indicate number of days for first occurrence; measured in days.
Measure: Mechanical Ventilation duration Time: Up to 90 daysDescription: Vital status will be reported as yes/no
Measure: Vital status (alive/dead) Time: Up to 90 daysDescription: If vital status is dead, cause of death will be documented.
Measure: Vital status (cause of death) Time: Up to 90 daysDescription: Measured by PCR assay of viral ribonucleic acid (RNA) from nasopharyngeal swab.
Measure: Viral load Time: from start of treatment to 90 daysThe aim is to analyze the feasibility and effect of an online Therapeutic Exercise and Education programme (TEEP) in cancer patient and survivors
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 monthsDescription: 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 monthsDescription: Total of days of attendance
Measure: Total attendance Time: After intervention, an average of 3 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsThe 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.
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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsThis 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.
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 registrationDescription: 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 registrationDescription: 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 registrationDescription: 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 registrationDescription: 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 registrationDescription: 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 registrationDescription: 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 registrationDescription: 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 registrationStudy 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.
Description: Deep venous thrombosis and/or pulmonary embolism.
Measure: Rate of venous thromboembolism Time: From Day 9 to Day 42Description: Rate of hospitalization
Measure: Hospitalization due to venous thromboembolism Time: Day 23Description: Time between the date of inclusion and the date of death for any reason.
Measure: Overall Survival Time: Day 23Description: Time between the date of inclusion and the date of death for venous thromboembolism.
Measure: Specific survival Time: Day 23Description: 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 23Description: 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 23Description: 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 23Description: 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 23This study evaluates the effects of the Survivorship Wellness Group Program following active treatment, as well as to learn from Survivorship Wellness participants about their concerns regarding the current COVID-19 pandemic. This study may help to evaluate the impact of the survivorship program on patient well-being, provide evidence for use in grant application and publications, and ultimately inform the continued improvement of survivorship care.
Description: The PROMIS Anxiety Short form consists of 2 items addressing patient anxiety with item response scores ranging from 1 (never) to 5 (Always). Raw scores are converted to scaled T-scores with higher scores indicating a greater level of anxiety. Significant changes over time and trends in patient reported outcomes will be analyzed via student's T-test.
Measure: Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Anxiety Short Form over time Time: Baseline, Week 9, and Week 15, up to 15 weeks totalDescription: The PROMIS Depression Short form consists of 4 items addressing patient depression with item response scores ranging from 1 (never) to 5 (Always). Raw scores are converted to scaled T-scores with higher scores indicating a greater level of depression. Significant changes over time and trends in patient reported outcomes will be analyzed via student's T-test.
Measure: Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form over time Time: Baseline, Week 9, and Week 15, up to 15 weeks totalDescription: The FACT-G is a 27-item questionnaire designed to measure four domains of health related quality of life (HRQOL) in cancer patients with 4 domains of interest: Physical, social, emotional, and functional well-being. Each tem response score ranges from 0 (not at all) to 5 (very much). The total score is a sum of the subscale scores, with a range from 0 - 108. The higher the score, the better the HRQOL.
Measure: Changes in the Functional Assessment of Cancer Therapy (FACT-G) scores Time: Baseline, Week 9, and Week 15, up to 15 weeks totalTo examine perceptions and determinants of physical activity during the COVID-19 pandemic among cancer survivors.
Description: Godin Leisure-Time Exercise Questionnaire
Measure: Physical Activity Time: 14 daysDescription: COVID-19 Pandemic Psychosocial Functioning Measure
Measure: Psychosocial Function during COVID-19 Time: 14 daysDescription: The Exercise Self-efficacy Scale will be used to measure confidence in ability to exercise. A higher score indicated a higher confidence.
Measure: Self-Efficacy Time: 14 daysDescription: The Pittsburgh Sleep Quality Index will be used to measure sleep quality and disturbances. A higher score indicates a higher sleep disturbance.
Measure: Sleep Quality Time: 14 daysDescription: The Functional Assessment in Chronic Illness Therapy - Fatigue (FACIT-F) will be used to measure fatigue as well. Higher scores indicate less fatigue.
Measure: Fatigue Time: 14 daysDescription: The Hospital Anxiety and Depression Scale (HADS) will be used to produce an anxiety score. Higher scores indicate higher symptoms of anxiety.
Measure: Anxiety Time: 14 daysDescription: The Hospital Anxiety and Depression Scale (HADS) will be used to produce an anxiety score. Higher scores indicate higher symptoms of depression.
Measure: Depression Time: 14 daysDescription: The UCLA Loneliness Scale will be used to measure feelings of loneliness and isolation. Higher scores indicate higher degrees of loneliness.
Measure: Loneliness Time: 14 daysDescription: The Rosenberg Self-Esteem Scale (RSE) will be used to measure global self-esteem. Items are used to calculate an esteem score, higher scores are indicative of higher esteem.
Measure: Global Self-Esteem Time: 14 daysDescription: The Functional Assessment in Cancer Therapy- Cognition (FACT-Cog) measures levels of cognitive impairment, quality of life and perceived cognitive ability. Items are summed up to calculate scores from each subsection.
Measure: Subjective Cognitive Impairment Time: 14 daysDescription: The Social Support of Exercise scale is aimed to assess the degree in which family and friends demonstrate support for exercise behavior. Higher scores indicate a higher level of support.
Measure: Social Support Time: 14 daysDescription: The Satisfaction of Life Scale (SWLS) is developed to assess global satisfaction is various age groups.
Measure: Satisfaction of Life Time: 14 daysDescription: The Perceived Stress Scale is a 10-item scale developed to measure the perceptions of a person's stress.
Measure: Stress Time: 14 daysDescription: A qualitative interview will be performed to measure the perceptions and barriers of exercise during the COVID-19 pandemic. This interview is comprised of items designed by the research team.
Measure: Perceptions of Exercise Time: up to one month after enrollmentCancer patients are among the most vulnerable individuals, whose health-related quality of life (HRQOL) may be substantially impacted by the COVID19 pandemic. We want to study how the COVID-19 pandemic influences the life of cancer patients and how these patients cope with the additional distress with the aim to facilitate the development of improved future interventional strategies to maintain resilience and HRQOL
Description: evaluation via questionnaire
Measure: Influence of the COVID-19 pandemic on cancer patient's daily life Time: single timeThis study investigates the experiences of cancer patients with neuropathy during the COVID-19 pandemic to learn how the COVID-19 pandemic affects their quality of life and clinical outcomes. This study will also explore whether there are differences between patients who received neurofeedback (NFB, a type of therapy that is thought to help normalize brain activity) and those who did not. Learning about quality of life in cancer patients with neuropathy during the COVID-19 pandemic may help guide development of programs and policies to improve chronic pain patient care and outcomes during a major global healthcare crisis.
Description: We will use the COVID-19 Specific questionnaire. This scale will ask 15 questions that are organized into three sections: (a) Questions specific to the COVID-19 pandemic such as testing, serostatus, risk factors, loss of family or friends, isolation; (b) Thoughts, experiences and emotions regarding the COVID-19 pandemic; and (c) Health-related quality of life. This assessment was developed by Lorenzo Cohen (MD Anderson), in collaboration with investigators from the University of Miami and UCLA and is a comprehensive assessment of COVID-19 experiences.
Measure: Health-related quality of life and coronavirus disease 2019 (COVID-19)-specific domains of interest Time: through study completion, an average of 6 monthsDescription: Will evaluate bivariate associations between COVID-19 experiences and COVID-19-specific distress, HRQOL and clinical outcomes, using Pearson product-moment correlation coefficients, chi-squared tests, or analyses of variance (ANOVA) where appropriate.
Measure: COVID-19 experiences and COVID-19 specific distress Time: through study completion, an average of 6 monthsDescription: Will use linear regression (or generalized linear models, as applicable) to assess differences in the outcomes of interest between neuropathic pain patients who received neurofeedback (NFB) from either of the two NFB trials (principal investigator [PI]: Dr. Prinsloo) and the neuropathic pain patients who participated in Dr. Gibby-Reyes' trial (who, consequently, did not receive NFB).
Measure: Differences in outcomes between neuropathic pain patients Time: through study completion, an average of 6 monthsDescription: Will preliminarily test the interaction effect between each of the coping and resilience factors and COVID-19 experiences on COVID-19-specific distress, HRQOL and clinical outcomes.
Measure: Coping and resilience factors Time: through study completion, an average of 6 monthsThis study determines how the threat of the coronavirus has affected the mental health and physical well-being of cancer patients seen at the psychiatric oncology clinic, and how they have coped with any related stress. Questionnaires that assess coping strategies and behaviors for decreasing disease transmission may help researchers create recommendations for future public health crises and pandemics.
Description: sum score on the Patient Health Questionnaire, a 9-item scale with a sumscore ranging between 0 and 27, with a higher score indicating more-severe depression.
Measure: Patient-reported severity of depression Time: BaselineDescription: sum score on the generalized anxiety disorder questionnaire, a 7-item scale with sumscore range between 0 and 21. A higher score indicates higher severity of anxiety.
Measure: Patient-reported severity of anxiety Time: BaselineDescription: score on the National Comprehensive Cancer Network Distress Thermometer, a one-item 0-10 scale. A higher score indicates higher distress.
Measure: Patient-reported severity of distress Time: BaselineDescription: Physical symptoms are assessed with individual-item response on the Edmonton Symptom Assessment Scale by the clinic. The ESAS includes 6 somatic symptom items, each of which is to be rated on a 0-10 scale, with higher scores indicating higher severity of the symptom.
Measure: Patient-reported physical symptoms Time: BaselineDescription: Substance use is documented by the treating physician and will be abstracted from clinic notes.
Measure: Substance use Time: BaselineDescription: Assessed using the brief COPE questionnaire. Will examine active versus avoidant coping. Active coping, planning, positive reframing, acceptance, humor, religion, emotional support-seeking, and instrumental support-seeking will be considered active coping strategies. Self-distraction, denial, venting, substance use, behavioral disengagement, and self-blame will be considered maladaptive coping strategies.
Measure: Patient-reported coping strategy Time: BaselineDescription: The Apathy evaluation Scale is an 18-item scale with a sum score ranging between 18 and 72. A higher scores indicates higher apathy..
Measure: Patient-reported levels of apathy Time: BaselineDescription: Patients indicate how often during the pandemic they engaged in the following 5 behaviors endorsed by the World Health Organization to decrease the transmission of coronavirus disease 2019 (COVID-19): washing hands regularly for 20 seconds with soap and water or alcohol-based hand rub, covering nose and mouth with a disposable tissue or flexed elbow when you cough or sneeze, avoiding close contact with people who are unwell, staying home and self-isolating from others in the household when feeling unwell, avoiding touching eyes, nose, and mouth when hands are unclean. The behaviors will be assessed on a Likert scale of 1-5, with 1 being "never" and 5 being "always". A not available (N/A) option will be given for staying home and self-isolating from others when feeling unwell, since participants may not experience a period of feeling unwell.
Measure: Patient-reported engagement in the 5 health behaviors endorsed by World Health Organization intended to curb the spread of the coronavirus Time: BaselineAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 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