Consortium on Translational Research in Early Detection of Liver Cancer: Data Management and Coordinating Center (DMCC)

肝癌早期检测转化研究联盟：数据管理和协调中心 (DMCC)

• 批准号: 10006517
• 负责人: Ziding Feng
• 金额: $ 55.37万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-17 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10006517
• 关键词: Bioinformatics; Biological Markers; Biological Specimen Banks; Biometry; Cancer Burden; Cancer Detection; Center for Translational Science Activities; Cirrhosis; Clinical; Clinical Data; Collaborations; Collection; Common Data Element; Communication; Computer Analysis; Consultations; Data; Data Collection; Data Set; Databases; Discipline; Early Diagnosis; Ensure; Evaluation; Evaluation Studies; Guidelines; Image; Information Technology; Infrastructure; Logistics; Malignant neoplasm of liver; Management Information Systems; Manuals; Medicine; Monitor; Patients; Phase; Prospective Studies; Protocols documentation; Public Health; Randomized; Research; Research Design; Research Personnel; Research Support; Retrospective Studies; Risk; Sampling; Scientist; Screening for Hepatocellular Cancer; Screening for cancer; Secure; Specimen; Statistical Data Interpretation; Statistical Methods; System; Testing; Translational Research; United States; University of Texas M D Anderson Cancer Center; Work; anticancer research; biobank; biomarker development; biomarker evaluation; cancer biomarkers; cohort; college; computerized data processing; data management; data sharing; data warehouse; experience; improved; informatics tool; innovation; instrument; meetings; operation; phase 3 study; protocol development; research study; success; symposium; validation studies; web site

Project Summary The key for the success of the Consortium on Translational Research in Early Detection of Liver Cancer (Consortium) lies in good communication among scientists in multiple disciplines; efficient evaluation and prioritization of promising biomarkers; and rigorous validation studies to demonstrate their clinical utilities in improving the surveillance and early detection of liver cancer and stratifying the risk of liver cancer in patients with cirrhosis. The overall aims of the proposed Data Management and Coordinating Center (DMCC) are to (i) enhance communication and collaboration among Consortium investigators; (ii) coordinate Consortium collaborative research and provide statistical support; (iii) develop and maintain an integrated research database and biorepository database for Consortium studies; and (iv) help the Consortium develop and implement strategies for biomarker translational paths. Under the direction of the Consortium Steering Committee, the DMCC will 1) perform network coordination and promote collaborations among scientific investigators by providing support for Consortium meetings, developing and maintaining Consortium secure websites and listservs, and producing and maintaining all Consortium documents; 2) support Consortium collaborative studies by working with Consortium investigators on study design, protocol development, data forms, and study manuals; coordinating and monitoring studies; tracking specimen sharing, blinding, and randomization; and performing QA/QC and study evaluation; 3) develop and maintain a Consortium integrated information management system that provides online, end-to- end data management solutions, including study communications, regulatory compliance, remote patient registration, clinical data capture, biospecimen sample management, imaging data repository, document management, and informatic tools; and 4) use the phased biomarker development guidelines and PRoBE study design standards to help the Consortium develop a roadmap and strategies and ensure rigor and efficiency of the Consortium collaborative phase-2 and phase-3 studies using existing and newly collected specimens from heterogeneous cohorts.

项目摘要 在早期检测肝的转化研究联盟成功的关键 癌症（财团）在多个学科中的科学家之间进行良好的沟通；高效的 有希望的生物标志物的评估和优先级；和严格的验证研究 证明他们在改善肝癌的监测和早期检测方面的临床实用性 并分层肝硬化患者患肝癌的风险。提议的总体目标 数据管理和协调中心（DMCC）将（i）增强通信和 财团调查员之间的合作； （ii）协调联盟合作研究 并提供统计支持； （iii）开发和维护一个集成的研究数据库和 用于财团研究的生物验证数据库； （iv）帮助财团发展和 实施生物标志物翻译路径的策略。 在财团指导委员会的指导下，DMCC将1）执行网络 通过提供支持，协调和促进科学研究人员之间的合作 财团会议，开发和维护财团安全的网站和列表服务以及 生产和维护所有财团文件； 2）支持联盟合作 通过与财团研究人员研究研究设计，协议开发，数据的研究 形式和学习手册；协调和监测研究；跟踪标本共享， 盲和随机化；并进行质量检查/QC和研究评估； 3）发展和 维护联盟综合信息管理系统，该系统可在线提供，端对时到 结束数据管理解决方案，包括研究通信，法规合规性，遥控 患者注册，临床数据捕获，生物测得样本管理，成像数据 存储库，文档管理和信息工具； 4）使用分阶段的生物标志物 开发指南和调查研究设计标准，以帮助联盟发展 路线图和策略，并确保财团协作阶段2的严格和效率 以及使用现有和新收集的异质队列标本的研究。