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.
The proposed study is highly relevant to public health because early detection has great potential to reduce liver cancer burden in United States and worldwide. Rigorous evaluation of biomarker tests for their clinical utility is imperative for public health.
