NCI COVID-19 in Cancer Patients, NCCAPS Study

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) 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.

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 severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19), including severity and fatality, in cancer patients undergoing treatment.

II. Describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation.

III. Evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics.

CORRELATIVE OBJECTIVES:

I. Future correlative biomarker objectives will include assessment of the development of SARS coronavirus 2 (SARS CoV-2) antibodies, description of the trajectory of cytokine abnormalities, and genome-wide association studies to define polymorphisms associated with severe COVID-19.

II. Future correlative imaging objectives will include assessment of COVID-19 sequelae in cancer patients.

III. Collection and banking of research blood specimens and radiological images for future research.

OUTLINE:

Patients undergo collection of medical information about COVID-19 symptoms, treatments/cancer treatments and outcomes, and results from laboratory tests and imaging scans performed as part of routine care for up to 2 years. Patients also undergo collection of blood samples at up to 9 times at the same times they receive routine bloodwork. Patients who are hospitalized for COVID-19 undergo collection of blood samples at up to 6 additional times.

Trial Phase Phase NA

Trial Type Observational

Lead Organization
National Cancer Institute

Principal Investigator
Larissa A. Korde

• Primary ID NCICOVID
• Secondary IDs NCI-2020-02986
• Clinicaltrials.gov ID NCT04387656