Page 12 - Delaware Medical Journal - July/August 2020

CANCER CLINICAL TRIAL
NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study
Primary Endpoint:
• Characterize patient factors, such as pre-existing comorbidities, cancer type, and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment.
• Describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation.
• Evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics.
Correlative Objectives:
• Correlative studies will be described and reviewed in a future amendment. Future correlative biomarker objectives will include assessment of the development of SARS CoV-2 antibodies, description of the trajectory of cytokine abnormalities, and genome-wide association studies to define polymorphisms associated with severe COVID-19. Future correlative imaging objectives will include assessment of COVID-19 sequelae in cancer patients.
• Collection and banking of research blood specimens and radiological images for future research.
Eligibility: Note: Patients can proceed immediately from Step 0 registration to Step 1 registration if they already have a positive SARS CoV-2 test result.
Step 0 Eligibility Criteria:
• Patients must be age ≥ 18 years. 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.
• 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
• Patient 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 CAR-T cell or other modified cellular therapy at any time; OR • Patient is currently receiving treatment or prophylaxis for Graft vs. Host Disease; OR
• Patient has received an autologous bone marrow transplant within the past 2 years.
Testing for SARS CoV-2: 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.
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.
For information regarding this clinical trial or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
156 Del Med J | July/August 2020 | Vol. 92 | No. 4