NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study
Overview
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.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
STEP 0 ELIGIBILITY CRITERIA
- Patient must have a prior or current cancer diagnosis (e.g., solid tumor or hematologic malignancy) that fits into any one of the following categories:
- Patient is receiving active treatment (defined as current treatment or treatment within the past 6 weeks) for metastatic cancer. Eligible 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, or radiation therapy; or
- Patients is receiving adjuvant treatment for non-metastatic (stage I-III) cancer and has received intravenous chemotherapy, immunotherapy, targeted therapy, or radiation therapy within the past 6 weeks; or
- Patient has received an allogenic stem cell 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 bone marrow transplant within the past 2 years.
- Patient must be undergoing or have undergone testing for SARS CoV-2. Patients with prior negative SARS CoV-2 test(s) are eligible if they are being tested again. Patients with prior positive SARS CoV-2 test(s) more than 14 days prior to enrollment are not eligible
- Human immunodeficiency virus (HIV)-infected patients are eligible
- Patients with brain metastases are eligible
- Co-enrollment on other clinical trials (for cancer or for COVID-19) is allowed
STEP 1 ELIGIBILITY CRITERIA: Positive SARS CoV-2 test within the 14 days prior to enrollment to Step 1.
- Patient must have a documented positive SARS CoV-2 test. The positive test results must have been received no earlier than 14 days prior to enrollment to Step 1. The test must have been ordered by a doctor's office, hospital, or department of public health. Any specimen source (e.g., nasopharyngeal swab, oropharyngeal swab, etc.) is allowable for the SARS CoV-2 test.
Learn More
To learn more, visit ClinicalTrials.Gov
Study Type
Observational
Principal Investigator(s)
Jeremy Kilburn, MD
Sponsor(s)
National Cancer Institute, NCI