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) 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.

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 coronavirus 2 (COVID-19), including symptoms, severity, and fatality, in adult and pediatric cancer patients undergoing treatment.

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

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

CORRELATIVE OBJECTIVES:

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

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

PATIENT-REPORTED HEALTH-RELATED QUALITY OF LIFE OBJECTIVES:

I. Describe patient-reported short-and long-term physical health, defined as a composite of physical function, pain interference and intensity, and ability to participate in social roles and activities, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-29 version (v)2.0 profile in adult cancer patients diagnosed with COVID-19. (Primary)

II. Describe patient-reported short-and long-term symptoms (anxiety, depression, and dyspnea) and function (cognitive function and social isolation) in adult cancer patients diagnosed with COVID-19. (Secondary)

III. Assess how patient-reported physical health (primary objective) and symptoms and function (secondary objective) in adult cancer patients vary by COVID-19 symptom burden, cancer type, cancer treatment, comorbidities, tobacco use, body mass index, and demographic characteristics. (Exploratory)

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 the same times they receive routine bloodwork up to 9 times for adults and up to 6 times for children. Patients who are hospitalized for COVID-19 undergo collection of blood samples at up to 6 additional times for adults and up to 3 additional times for children. Adult patients also complete quality of life questionnaire.

Trial Phase Phase NA

Trial Type Registry

Lead Organization
National Cancer Institute

Principal Investigator
Larissa A. Korde

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