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

项目摘要 翻译研究联合体在肝脏早期检测中取得成功的关键 癌症(联盟)在于多学科科学家之间的良好沟通；高效 有前景的生物标志物的评估和优先顺序；以及严格的验证研究，以 展示它们在改善对肝癌的监测和早期发现方面的临床效用 以及对肝硬变患者患肝癌的风险进行分层。拟议方案的总体目标 数据管理和协调中心(DMCC)将(I)加强沟通和 财团调查人员之间的合作；(2)协调财团合作研究 并提供统计支助；(3)开发和维护一个综合研究数据库和 用于财团研究的生物信息库数据库；以及(Iv)帮助财团开发和 实施生物标记物翻译路径的策略。 在财团指导委员会的指导下，DMCC将1)实施网络 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网站和列表服务器，以及 制作和维护所有财团文件；2)支持财团协作 通过与联合会调查人员在研究设计、方案开发、数据方面的合作进行研究 表格和研究手册；协调和监测研究；跟踪标本共享， 盲法和随机化；以及执行QA/QC和研究评估；3)开发和 维护财团集成信息管理系统，提供在线、端到端的 终端数据管理解决方案，包括研究通信、法规遵从性、远程 患者注册、临床数据捕获、生物样品管理、成像数据 存储库、文档管理和信息工具；以及4)使用阶段性生物标志物 开发指南和探索性研究设计标准，以帮助财团制定 路线图和战略，并确保财团协作阶段2的严谨和高效 以及第三阶段研究，使用现有的和新收集的来自不同队列的样本。

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.