DATA MANAGEMENT FOR CANCER DIAGNOSIS PROGRAM ACTIVITIES

国家癌症研究所(NCI)是国家卫生研究院(NIH)内的一个研究所，NIH是组成公共卫生服务(PHS)、卫生和公共服务部(DHHS)的八个机构之一。NCI的任务是计划、实施和协调国家癌症计划，包括(A)研究癌症的原因、检测、诊断、预防、治疗和姑息治疗以及癌症患者的康复，以及(B)展示癌症控制方法和技术的有效性。 二、背景资料 美国国立卫生研究院癌症治疗与诊断部发起了一项自然历史研究，即NCI新冠肺炎在癌症患者中的研究：一项纵向自然历史研究，旨在调查SARS-CoV-2阳性检测结果为癌症患者的病程。 新冠肺炎。在NCI的临床试验网络中，登记的患者将在两年内收集临床数据、成像数据和纵向血液或其他生物样本进行实验室分析。NCI将使用其现有的Medidata Rave系统获取和管理临床数据，并使用成像和放射肿瘤学核心(IROC)来管理成像数据。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系。实验室研究将在多个机构进行， 在NCI-Frederick以及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，并与参与实验室和研究小组的其他成员合作。

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.