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: 10734730
• 负责人: Ziding Feng
• 金额: $ 73.8万
• 依托单位: FRED HUTCHINSON CANCER 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 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10734730
• 关键词: Address; Artificial Intelligence; Bioinformatics; Biological Markers; Biological Specimen Banks; Biological Specimen database; Biometry; Cancer Burden; Cancer Center; Cancer Detection; Center for Translational Science Activities; Cirrhosis; Clinical; Clinical Data; Cohort Studies; Collaborations; Collection; Common Data Element; Communication; Computer Analysis; Consultations; Country; Dana-Farber Cancer Institute; Data; Data Collection; Data Coordinating Center; Data Management Resources; Data Science; Data Set; Databases; Discipline; Early Detection Research Network; Early Diagnosis; Ensure; Evaluation; Evaluation Studies; Image; Information Technology; Infrastructure; Lead; Leadership; Liver; Malignant Neoplasms; Malignant neoplasm of liver; Manuals; Mission; Modeling; Monitor; Nodule; Output; Patients; Procedures; Prospective Studies; Prospective, cohort study; Protocols documentation; Public Health; Qualifying; Randomized; Research; Research Design; Research Personnel; Research Support; Retrospective Studies; Risk; Sampling; Science; Scientist; Screening for Hepatocellular Cancer; Secure; Services; Specimen; Statistical Data Interpretation; Statistical Methods; System; Testing; Time; Translational Research; United States; University of Texas M D Anderson Cancer Center; Work; anticancer research; artificial intelligence method; biomarker evaluation; cancer biomarkers; computational intelligence; computerized data processing; data management; data repository; data sharing; experience; improved; informatics tool; innovation; instrument; meetings; operation; programs; protocol development; research study; risk stratification; success; symposium; validation studies; web site

PROJECT SUMMARY ABSTRACT The key to 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 potential 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 integrated research and biorepository databases for Consortium studies; and (iv) support and facilitate trans-Consortium collaborative research. 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 and conference calls, developing and maintaining all Consortium documents, including the Manual of Operations and Procedures (MOP), and by maintaining and enhancing the Consortium’s secure website; 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) maintain and enhance the COMPASS Data Management System (CDMS) used to facilitate Consortium collaborative activities. CDMS provides online, end- to-end data management solutions, including investigator and study coordinator communications, regulatory compliance, remote subject registration, clinical data capture, biospecimen sample management, imaging data repository, and document management. CDMS can provide online visibility of analytical datasets for all participating researchers, and statistical and informatic tools relevant to Consortium research; 4) support and facilitate trans-Consortium collaborative studies by promoting team science, monitoring study procedures, and using cutting edge statistical, computational, and Artificial Intelligence methods to ensure efficient yet rigorous study design and maximize research outputs. Our research strategy is built from this guiding principle: provide the highest quality service to the Consortium while remaining innovative and providing scientific leadership to help the Consortium achieve its mission. Our qualifications include being the DMCC for the Early Detection Research Network since its inception, serving as lead statisticians for the two largest ongoing cirrhosis cohort studies in this country, and being responsible for two FDA-cleared Imaging AI products and many statistical innovations in early detection research.

项目摘要 肝癌早期检测转化研究联盟（Consortium on Translational Research in Early Detection of Liver Cancer） 在于多学科科学家之间的良好沟通，有效的评估和优先考虑 有前途的生物标志物，以及严格的验证研究，以证明它们在改善 肝癌的监测和早期发现以及肝硬化患者患肝癌的风险分层。 拟议的数据管理和协调中心的总体目标是：（i）加强 （二）研究人员之间的沟通和协作;（二）协调研究人员之间的协作 研究和提供统计支持; ㈢发展和维持综合研究和生物储存库 数据库的联盟研究;及（iv）支持和促进跨联盟合作研究。 在联合体指导委员会的指导下，DMCC将1）执行网络协调， 通过为联合会会议提供支持，促进科学调查人员之间的合作， 电话会议，开发和维护所有联合体文件，包括操作手册， 程序（MOP），并通过维护和加强联盟的安全网站; 2）支持联盟 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）维护和增强COMPASS数据 管理系统（CDMS）用于促进联合体的合作活动。CDMS提供在线、端- 端到端数据管理解决方案，包括研究者和研究协调员通信、监管 合规性、远程受试者注册、临床数据采集、生物标本样本管理、成像数据 存储库和文档管理。CDMS可以为所有人提供分析数据集的在线可见性 参与研究人员，以及与联盟研究相关的统计和信息工具; 4）支持和 通过促进团队科学，监测研究程序，促进跨联盟合作研究， 使用尖端的统计、计算和人工智能方法，确保高效而严格的 研究设计和最大限度地提高研究成果。 我们的研究战略是建立在这样一个指导原则：为财团提供最高质量的服务 同时保持创新并提供科学领导，以帮助该联盟实现其使命。我们 资格包括自成立以来一直是早期探测研究网络的DMCC， 在这个国家，两个最大的正在进行的肝硬化队列研究的主要统计学家， 两个FDA批准的成像AI产品和早期检测研究中的许多统计创新。