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

项目摘要 肝脏早期检测转化研究联盟成功的关键 癌症（联盟）在于多学科科学家之间的良好沟通;高效 评估和优先考虑有前途的生物标志物;和严格的验证研究， 证明它们在改善肝癌监测和早期发现方面的临床效用 并对肝硬化患者患肝癌的风险进行分层。建议的总体目标 数据管理和协调中心（DMCC）将（i）加强沟通， （二）协调联合会合作研究 （iii）发展和维持一个综合研究数据库， （四）帮助企业发展和 实施生物标记物翻译路径的策略。 在联合体指导委员会的指导下，DMCC将1）执行网络 通过提供支持来协调并促进科学研究人员之间的合作 联合会会议，开发和维护联合会安全网站和邮件列表服务器，以及 制作和维护所有的联合体文件; 2）支持联合体的协作 通过与联盟研究者合作进行研究设计、方案制定、数据 表格和研究手册;协调和监测研究;跟踪样本共享， 设盲和随机化;进行QA/QC和研究评价; 3）制定和 维护一个联合体综合信息管理系统，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 患者登记、临床数据采集、生物样本管理、成像数据 存储库、文档管理和信息工具;以及4）使用分阶段生物标志物 发展指南和PRoBE研究设计标准，以帮助财团制定一个 路线图和战略，并确保联盟协作第二阶段的严格性和效率 以及使用来自异质性队列的现有和新采集标本的III期研究。

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.