Status:
ACTIVE_NOT_RECRUITING
NCI COVID-19 in Cancer Patients, NCCAPS Study
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
COVID-19 Infection
Hematopoietic and Lymphatic System Neoplasm
Eligibility:
All Genders
Brief 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 d...
Detailed Description
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 coronavir...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 3 2026
Estimated Enrollment :
1877 Patients enrolled
Trial Details
Trial ID
NCT04387656
Start Date
June 5 2020
End Date
October 3 2026
Last Update
January 9 2026
Active Locations (935)
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1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
Veterans Administration Medical Center - Birmingham
Birmingham, Alabama, United States, 35233
3
USA Health Strada Patient Care Center
Mobile, Alabama, United States, 36604
4
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States, 98508