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肺 EDRN-CVC 对 1 期、2 期和 3 期生物标志物验证研究的影响。

The impact of the lung EDRN-CVC on Phase 1, 2, & 3 biomarker validation studies.

机构信息

Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.

Department of Thoracic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.

出版信息

Cancer Biomark. 2022;33(4):449-465. doi: 10.3233/CBM-210382.

DOI:10.3233/CBM-210382
PMID:35491773
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10860588/
Abstract

The Early Detection Research Network's (EDRN) purpose is to discover, develop and validate biomarkers and imaging methods to detect early-stage cancers or at-risk individuals. The EDRN is composed of sites that fall into four categories: Biomarker Developmental Laboratories (BDL), Biomarker Reference Laboratories (BRL), Clinical Validation Centers (CVC) and Data Management and Coordinating Centers. Each component has a crucial role to play within the mission of the EDRN. The primary role of the CVCs is to support biomarker developers through validation trials on promising biomarkers discovered by both EDRN and non-EDRN investigators. The second round of funding for the EDRN Lung CVC at Vanderbilt University Medical Center (VUMC) was funded in October 2016 and we intended to accomplish the three missions of the CVCs: To conduct innovative research on the validation of candidate biomarkers for early cancer detection and risk assessment of lung cancer in an observational study; to compare biomarker performance; and to serve as a resource center for collaborative research within the Network and partner with established EDRN BDLs and BRLs, new laboratories and industry partners. This report outlines the impact of the VUMC EDRN Lung CVC and describes the role in promoting and validating biological and imaging biomarkers.

摘要

早期检测研究网络(EDRN)的目的是发现、开发和验证生物标志物和成像方法,以检测早期癌症或高危个体。EDRN 由四个类别中的站点组成:生物标志物开发实验室(BDL)、生物标志物参考实验室(BRL)、临床验证中心(CVC)和数据管理与协调中心。每个组成部分在 EDRN 的使命中都发挥着至关重要的作用。CVC 的主要作用是通过对 EDRN 和非 EDRN 研究人员发现的有前途的生物标志物进行验证试验,为生物标志物开发人员提供支持。范德比尔特大学医学中心(VUMC)的 EDRN 肺癌 CVC 的第二轮资金于 2016 年 10 月获得资助,我们旨在完成 CVC 的三个任务:在观察性研究中对候选生物标志物进行创新性研究,以验证早期癌症检测和肺癌风险评估;比较生物标志物的性能;并作为网络内协作研究的资源中心,并与已建立的 EDRN BDL 和 BRL、新实验室和行业合作伙伴合作。本报告概述了 VUMC EDRN 肺癌 CVC 的影响,并描述了其在促进和验证生物和成像生物标志物方面的作用。

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