DATA MANAGEMENT FOR CANCER DIAGNOSIS PROGRAM ACTIVITIES

The National Cancer Institute (NCI) is an institute within the National Institutes of Health (NIH), one of eight agencies that compose the Public Health Service (PHS), Department of Health and Human Services (DHHS). The mission of the NCI is to plan, conduct, and coordinate the National Cancer program and involves (a) research on the causes, detection, diagnosis, prevention, treatment, and palliative care of cancers and on rehabilitation of the cancer patient and (b) demonstration of the effectiveness of cancer control methods and techniques.

II. Background

The Division of Cancer Treatment and Diagnosis (DCTD) of the NCI has initiated a natural history study, NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study to investigate the course of disease in cancer patients with positive test results for SARS-CoV-2, the virus that causes the

disease COVID-19. Across the NCI’s clinical trials networks, patients who enroll will have clinical data, imaging data and longitudinal blood or other biospecimens collected over a two-year period for laboratory analysis. NCI will use its existing Medidata Rave system to acquire and manage the clinical data and the Imaging and Radiation Oncology Core (IROC) to manage the imaging data.

Several different kinds of laboratory analyses are planned to investigate biological aspects of the disease, including but not limited to genomics, serology, and immune response, and to examine associations of biological features with clinical variables and outcomes. Laboratory studies will take place at multiple institutions,

both at NCI-Frederick and at several non-government academic and commercial laboratories. The data analysis effort will be led by the Biometric Research Program (BRP) in DCTD, in collaboration with the participating laboratories and other members of the study team.