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ACTIVE NOT RECRUITING

NCT04387656

NCI COVID-19 in Cancer Patients, NCCAPS Study

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

1877

Start Date

2020-06-05

Completion Date

2027-10-14

Last Updated

2026-10-26

Healthy Volunteers

Conditions

COVID-19 Infection Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

OTHER

Data Collection

Undergo collection of medical information and imaging

OTHER

Quality-of-Life Assessment

Complete quality of life questionnaires

OTHER

Questionnaire Administration

Complete quality of life questionnaires

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 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

Locations (932)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Veterans Administration Medical Center - Birmingham

Birmingham, Alabama, United States

USA Health Strada Patient Care Center

Mobile, Alabama, United States

Anchorage Associates in Radiation Medicine