DATA MANAGEMENT FOR CANCER DIAGNOSIS PROGRAM ACTIVITIES

国家癌症研究所（NCI）是美国国立卫生研究院（NIH）的一个研究所，是组成公共卫生服务（PHS），卫生与人类服务部（DHHS）的八个机构之一。国家癌症研究所的使命是规划、实施和协调国家癌症方案，包括：（a）研究癌症的病因、检测、诊断、预防、治疗和姑息治疗，以及癌症患者的康复;（B）展示癌症控制方法和技术的有效性。 二.背景 NCI的癌症治疗和诊断部门（DCTD）启动了一项自然史研究，NCI COVID-19癌症患者研究（NCCAPS）：纵向自然史研究，以调查SARS-CoV-2检测结果阳性的癌症患者的病程，该病毒导致癌症患者的死亡。 疾病COVID-19。在NCI的临床试验网络中，登记的患者将获得临床数据，成像数据和纵向血液或其他生物标本，这些标本将在两年的时间内收集，用于实验室分析。NCI将使用其现有的Medidata Rave系统采集和管理临床数据，并使用成像和放射肿瘤学核心（IROC）管理成像数据。计划进行几种不同类型的实验室分析，以调查疾病的生物学方面，包括但不限于基因组学，血清学和免疫反应，并检查生物学特征与临床变量和结果的关联。实验室研究将在多个机构进行， 无论是在NCI-Frederick和几个非政府的学术和商业实验室。数据分析工作将由DCTD的生物识别研究计划（BRP）领导，与参与实验室和研究团队的其他成员合作。

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.