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NCI COVID-19 in Cancer Patients, NCCAPS Study (NCI COVID, N-CCaPS)

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

Overview

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

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

Learn More

To learn more, visit ClinicalTrials.Gov

Study Type

Observational

Principal Investigator(s)

Jeremy Kilburn, MD

Sponsor(s)

National Cancer Institute, NCI

Contact Us

Contact Us

To participate in this study, please contact Emily Collins at
864-530-6520
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