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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

NCI COVID-19 in Cancer Patients, NCCAPS Study

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.
Miscellaneous
N/A
Both
Not Available
Not Available
Rini, Brian
International
Vanderbilt University
08-20-2020
Other
VICCNCIMDCOVID-19
NCT04387656

Eligibility

0 Years
BOTH
NO
Inclusion Criteria:

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) or will begin receiving treatment within the next 2 weeks for any central nervous system (CNS) or hematologic malignancy or metastatic (stage IV) solid tumor. Eligible treatment types for hematologic malignancy or metastatic cancer 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 * Patient is receiving treatment (defined as current treatment or treatment within the past 6 weeks) or will begin receiving treatment within the next 2 weeks for non-metastatic (stage I-III) solid tumor. Eligible treatment types for non-metastatic cancer patients are intravenous chemotherapy, immunotherapy, targeted therapy, radiation therapy, targeted radionuclide therapy, or monoclonal antibody therapy, except trastuzumab/pertuzumab if not accompanied by chemotherapy; 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 have a pending or known positive viral test result for SARS-CoV-2. Patients with prior negative viral SARS CoV-2 test(s) are eligible if they are being tested again. Patients 18 years of age and older with prior positive viral SARS CoV-2 test(s) more than 14 days prior to enrollment to Step 1 are not eligible

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

STEP 1 ELIGIBILITY CRITERIA: Positive viral SARS CoV-2 test * Patient must have a documented positive viral SARS CoV-2 test ** For patients 18 years of age or older, the specimen collection for the positive test must have occurred no earlier than 14 days prior to enrollment to Step 1 ** For patients under 18 years of age, the specimen collection for the positive test must have occurred after January 31, 2020 * The viral test can be either a nucleic acid (PCR) test or an antigen test. Serological or antibody tests are not allowed. The test must have received Emergency Use Approval (EUA) from the Food and Drug Administration (FDA) and be performed in a Clinical Laboratory Improvement Act (CLIA) certified lab or patient care setting operating under a CLIA Certificate of Waiver. A full list of tests that have been approved under the EUA can be accessed at: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas Any specimen source (e.g., nasopharyngeal swab, oropharyngeal swab, etc.) is allowable for the viral SARS-CoV-2 test.

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