NCI COVID-19 in Cancer Patients, NCCAPS Study

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVES: I. Characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of coronavirus 2019 (COVID-19), including symptoms, severity, and fatality, in adult and pediatric cancer patients undergoing treatment. II. Describe cancer treatment modifications made in response to COVID-19 in adult and pediatric patients, including dose adjustments, changes in symptom management, or temporary or permanent cessation. III. Evaluate the association of COVID-19 with cancer outcomes in adult patient subgroups defined by clinico-pathologic characteristics and in pediatric patients. EXPLORATORY CORRELATIVE OBJECTIVES: I. Study the immune response to COVID-19 in patients with cancer by assessing cytokines by Olink profiling and the cellular compartment of the immune system using mass cytometry (CyTOF). II. Describe coagulation abnormalities in COVID-19 cancer patients. III. Describe the development of severe acute respiratory syndrome (SARS) coronavirus 2 (SARS CoV-2) antibodies and neutralizing antibodies in cancer patients. IV. Investigate both common and rare genetic variants associated with differences in disease outcome using a case-case design to increase understanding of COVID-19 disease in cancer patients using large-scale genome-wide association studies and whole genome sequencing. V. Characterize the development and longevity of vaccine-induced immunity using serology (ligand-binding assays) and neutralizing antibodies. VI. Collect and bank research blood specimens and radiological images for future research. PATIENT-REPORTED HEALTH-RELATED QUALITY OF LIFE OBJECTIVES: I. Describe patient-reported short-and long-term physical health, defined as a composite of physical function, pain interference and intensity, and ability to participate in social roles and activities, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-29 version (v)2.0 profile in adult cancer patients diagnosed with COVID-19. (Primary) II. Describe patient-reported short-and long-term symptoms (anxiety, depression, and dyspnea) and function (cognitive function and social isolation) in adult cancer patients diagnosed with COVID-19. (Secondary) III. Assess how patient-reported physical health (primary objective) and symptoms and function (secondary objective) in adult cancer patients vary by COVID-19 symptom burden, cancer type, cancer treatment, comorbidities, tobacco use, body mass index, and demographic characteristics. (Exploratory) PEDIATRIC COVNET COHORT OBJECTIVE (FOR PATIENTS < 18 YEARS OLD): I. Investigate both common and rare variants associated with differences in disease outcome using a case-case design for children and adolescents, < 18 years old to increase understanding of COVID-19 in pediatric cancer patients. OUTLINE: Patients undergo collection of medical information about COVID-19 symptoms, treatments/cancer treatments and outcomes, and results from laboratory tests and imaging scans performed as part of routine care for up to 2 years. Patients also undergo collection of blood samples at the same times they receive routine bloodwork up to 8 times for adults and up to 5 times for children. Patients who are hospitalized for COVID-19 undergo collection of blood samples at up to 6 additional times for adults and up to 3 additional times for children. Adult patients also complete quality of life questionnaire.

Official Title
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NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study

Conditions
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COVID-19 Infection, Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Data Collection
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NCCAPS STUDY ELIGIBILITY CRITERIA: Patient must have a prior or current cancer diagnosis (e.g., solid tumor or hematologic malignancy) and cancer treatment that fits into one of the three following categories: Metastatic (stage IV) solid tumor, any hematologic malignancy, or any central nervous system (CNS) malignancy, and: Patient is receiving eligible active treatment (defined as current treatment or treatment within the 6 weeks prior to their first positive SARS-CoV-2 test collection) or is expected to begin receiving treatment within 2 weeks of study enrollment Eligible active treatment types are chemotherapy, immunotherapy, monoclonal antibody therapy (e.g., rituximab, trastuzumab, cetuximab), targeted therapy (e.g., BRAF/MEK inhibitor, EGF-R inhibitor), endocrine therapy, radiation therapy, or targeted radionuclide therapy; OR Non-metastatic (Stage I-III) solid tumor and: Patient is receiving eligible active treatment (defined as current treatment or treatment within past 6 weeks prior to their first positive SARS-CoV-2 test collection) or is expected to begin receiving treatment within 2 weeks of study enrollment Eligible active treatment types for non-metastatic solid tumor patients are intravenous chemotherapy, immunotherapy, targeted therapy, radiation therapy, targeted radionuclide therapy, or monoclonal antibody therapy (except as noted below) HER2-targeted therapy (trastuzumab, pertuzumab, neratinib, ado-trastuzumab) that is not accompanied by chemotherapy is NOT considered an eligible active treatment Patients on endocrine therapy alone are not eligible; OR Prior or current transplant for the treatment of cancer: Patient has received an allogenic stem cell/bone marrow transplant or chimeric antigen receptor (CAR)-T cell or other modified cellular therapy at any time; or Patient is currently receiving treatment or prophylaxis for graft graft versus (vs.) host disease; or Patient has received an autologous stem cell/bone marrow transplant within the past 2 years Patient must have documented positive viral test result for SARS-CoV-2 For patients 18 years of age or older, the specimen collection for the patient's FIRST positive test must have occurred no earlier than 14 days prior to enrollment For patients under 18 years of age, the specimen collection for the patient's first positive test must have occurred after January 31, 2020 The viral test can be either a nucleic acid (polymerase chain reaction [PCR]) test or an antigen test. Serological or antibody tests are not allowed Any specimen source (e.g., nasopharyngeal swab, oropharyngeal swab, etc.) is allowable for the viral SARS-CoV-2 test Patients with prior negative viral SARS-CoV-2 test(s) are eligible if they are being tested again The SARS-CoV-2 test must be a validated diagnostic assay performed in accordance with the most recent guidance issued by the Food and Drug administration (FDA) in the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. This policy is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised Human immunodeficiency virus (HIV)-infected patients are eligible Patients with CNS metastases are eligible Co-enrollment on other clinical trials (for cancer or for COVID-19) is allowed PEDIATRIC COVNET COHORT ELIGIBILITY CRITERIA: Patients should only be enrolled in the pediatric COVNET cohort if they are not eligible for the main NCCAPS Study cohort or decline to participate in the main study Patient must be < 18 years of age Patient must have a positive SARS-CoV-2 viral test after January 31, 2020 Patient must have a current or prior diagnosis of cancer. Active cancer treatment is not required Note: Patients who enroll on Pediatric COVNET cohort will not be followed longitudinally; study data collection involves only a single questionnaire and research blood collection. A separate consent document is provided for the Pediatric COVNET cohort
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational Cohort (data collection, biospecimen collection)<br>Patients undergo collection of medical information about COVID-19 symptoms, treatments/cancer treatments and outcomes, and results from laboratory tests and imaging scans performed as part of routine care for up to 2 years. Patients also undergo collection of blood samples at the same times they receive routine bloodwork up to 8 times for adults and up to 5 times for children. Patients who are hospitalized for COVID-19 undergo collection of blood samples at up to 6 additional times for adults and up to 3 additional times for children. Adult patients also complete quality of life questionnaire. | Procedure: Biospecimen Collection<br>* Undergo collection of blood samples<br>* Other names: Specimen Collection;Other: Data Collection<br>* Undergo collection of medical information and imaging<br>Other: Quality-of-Life Assessment<br>* Complete quality of life questionnaires<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Complete quality of life questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity | 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. | Up to 2 years | 
| Effects of COVID-19 on cancer therapy and association with clinical outcomes | 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. | Up to 2 years | 
| Physical health (patient-reported health-related quality of life) | Will be measured using items from the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Profile. | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19