DATA MANAGEMENT FOR CANCER DIAGNOSIS PROGRAM ACTIVITIES

癌症诊断计划活动的数据管理

• 批准号: 10849595
• 负责人: DAVE ANNETTE
• 金额: $ 84.25万
• 依托单位: INFORMATION MANAGEMENT SERVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10849595
• 关键词: 2019-nCoV; Address; Adopted; Biological; Biological Assay; Biological Markers; Biometry; Blood; COVID-19; Cancer Control; Cancer Patient; Characteristics; Clinical; Clinical Data; Clinical Management; Clinical Trials; Clinical Trials Network; Collaborations; Communication; Computers; Consult; Consultations; Contractor; Custom; Data; Data Analyses; Data Collection; Data Commons; Data Element; Data Files; Data Security; Data Set; Databases; Detection; Development; Diagnosis; Disease; Division of Cancer Treatment and Diagnosis; Documentation; Effectiveness; Electronic Mail; Electronics; Enrollment; Ensure; Event; Excision; Extramural Activities; Failure; Frequencies; Generations; Genomics; Grant; Group Meetings; Human Resources; Image; Immune response; Individual; Institution; Laboratories; Laboratory Study; Length; Link; Logic; Logistics; Manuals; Master of Science; Medidata; Methods; Mission; Modification; Molecular Analysis; Monitor; Names; National Cancer Institute; National Cancer Program; Natural History; Online Systems; Outcome; Patients; Performance; Positive Test Result; Preparation; Prevention; Process; Production; Quality Control; Radiation Oncology; Recurrence; Reporting; Research; Research Personnel; Resources; Secure; Serology; Services; Shipping; Specific qualifier value; Specimen; Statistical Data Interpretation; Structure; Support Contracts; System; Techniques; Telephone; Text; Time; United States Dept. of Health and Human Services; United States National Institutes of Health; United States Public Health Service; Update; Virus; anticancer research; application programming interface; biobank; cancer diagnosis; cancer palliative treatment; cancer rehabilitation; clinical database; clinical research site; data acquisition; data de-identification; data exchange; data management; data repository; design; experience; falls; follow-up; individual responsibility; meetings; member; programs; sample collection; statistics; success; symposium; timeline; working group; 2019-nCoV; Address; Adopted; Biological; Biological Assay; Biological Markers; Biometry; Blood; COVID-19; Cancer Control; Cancer Patient; Characteristics; Clinical; Clinical Data; Clinical Management; Clinical Trials; Clinical Trials Network; Collaborations; Communication; Computers; Consult; Consultations; Contractor; Custom; Data; Data Analyses; Data Collection; Data Commons; Data Element; Data Files; Data Security; Data Set; Databases; Detection; Development; Diagnosis; Disease; Division of Cancer Treatment and Diagnosis; Documentation; Effectiveness; Electronic Mail; Electronics; Enrollment; Ensure; Event; Excision; Extramural Activities; Failure; Frequencies; Generations; Genomics; Grant; Group Meetings; Human Resources; Image; Immune response; Individual; Institution; Laboratories; Laboratory Study; Length; Link; Logic; Logistics; Manuals; Master of Science; Medidata; Methods; Mission; Modification; Molecular Analysis; Monitor; Names; National Cancer Institute; National Cancer Program; Natural History; Online Systems; Outcome; Patients; Performance; Positive Test Result; Preparation; Prevention; Process; Production; Quality Control; Radiation Oncology; Recurrence; Reporting; Research; Research Personnel; Resources; Secure; Serology; Services; Shipping; Specific qualifier value; Specimen; Statistical Data Interpretation; Structure; Support Contracts; System; Techniques; Telephone; Text; Time; United States Dept. of Health and Human Services; United States National Institutes of Health; United States Public Health Service; Update; Virus; anticancer research; application programming interface; biobank; cancer diagnosis; cancer palliative treatment; cancer rehabilitation; clinical database; clinical research site; data acquisition; data de-identification; data exchange; data management; data repository; design; experience; falls; follow-up; individual responsibility; meetings; member; programs; sample collection; statistics; success; symposium; timeline; working group

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.

国家癌症研究所（NCI）是美国国立卫生研究院（NIH）的一家研究所，该研究所是卫生与公共服务部（DHHS）组成公共卫生服务（PHS）的八个机构之一。 NCI的任务是计划，进行和协调国家癌症计划，并涉及（a）研究癌症的原因，检测，诊断，预防，治疗，治疗和姑息治疗，以及对癌症患者的康复以及（b）证明癌症控制方法和技术的有效性。 ii。背景 NCI的癌症治疗和诊断（DCTD）启动了一项自然史研究，NCI COVID-19中的癌症患者研究（NCCAPS）：一项纵向自然史研究，研究了SARS-COV-2的癌症患者疾病进程的过程，导致该病毒，该病毒是该病毒 疾病19岁。在NCI的临床试验网络中，注册的患者将拥有临床数据，成像数据和纵向血液或在两年内收集的其他生物素质进行实验室分析。 NCI将使用其现有的Medidata狂欢系统来获取和管理临床数据以及成像和辐射肿瘤核心（IROC）来管理成像数据。计划进行几种不同类型的实验室分析，以研究该疾病的生物学方面，包括但不限于基因组学，血清学和免疫响应，并研究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， 在NCI-Frederick和几个非政府学术和商业实验室。数据分析工作将由DCTD的生物识别研究计划（BRP）领导，并与参与的实验室和研究团队的其他成员合作。