Great Lakes New England Clinical Validation Center

五大湖新英格兰临床验证中心（GLNE CVC），临床验证联盟 早期发现研究网络（EDRN）的一个组成部分是一个高度合作的研究小组 其目的是验证用于胃肠道癌症早期检测和风险评估的生物标志物， 道。在这第五个竞争性应用程序中，GLNE继续测试整体假设， 基于循环和粪便的生物标志物将增加对结肠直肠筛查的依从性， 结直肠癌导致的死亡率。基于成年人结直肠癌（CRC）发病率的上升， 在美国，年龄<50岁，以及服务不足人群的低依从性和高死亡率， 都是针对这些人的GLNE还建议继续支持EDRN发现 优先事项我们建议实现以下目标：（1）主要目标 EDRN使用的适当保存的粪便、血清、血浆、尿液、组织和DNA生物标本 研究人员对当前和未来的验证和生物标志物发现研究进行了扩展， 早发CRC受试者和服务不足人群。这将有助于评估个人的效用。 基于粪便和基于血清的生物标志物和生物标志物组，用于区分个体， 肿瘤（处于结肠癌平均风险和较高风险的受试者）和结肠癌患者 或筛查相关瘤形成（癌症加晚期腺瘤），以及构建标记物组， 区别对待这些群体。(2)对EDRN发现的有前景的生物标志物进行验证试验 研究人员、外部合作机构和EDRN工业合作伙伴，以进行早期检测 结直肠肿瘤在这种情况下，我们建议（a）进行临床验证（通过方法比较研究） 基于血液的即时生物标志物面板在检测血清/血浆样本时的性能 在服务于低收入和服务不足社区的诊所中获得，以及（B）临床验证已建立的 4-复合粪便蛋白检测对结直肠癌早期诊断的价值(3)前瞻性随访入组的受试者， 已建立的前瞻性II期验证试验，以确定可用于 开发预测标记。

The Great Lakes New England Clinical Validation Center (GLNE CVC), a Clinical Validation Consortium component of the Early Detection Research Network (EDRN) is a highly collaborative group of investigators whose aims to validate biomarkers for the early detection and risk assessment of cancers of the gastrointestinal tract. In this fifth competitive application, the GLNE continues to test the overall hypothesis that a panel of circulating and stool based biomarkers will increase the adherence to colorectal screening and in doing so reduce mortality caused by colorectal cancers. Based on the rising incidence of colorectal cancer (CRC) among adults age <50 in the US, and the low compliance and high mortality in underserved populations, increased emphasis is placed on these populations. The GLNE also proposes to continue its ongoing support of EDRN discovery priorities. We propose to address the following aims: (1) Primary Aim To expand and renew the archive of appropriately preserved stool, serum, plasma, urine, tissue and DNA biospecimens to be used by EDRN investigators for current and future validation and biomarker discovery research with expanded inclusion of subjects with early-onset CRC and underserved populations. This will allow assessment of the utility of individual stool-based, and serum-based biomarkers and biomarker panels for discriminating between individuals without neoplasia (subjects both at average and higher risk for developing colon cancer), and those with colon cancer or screen-relevant neoplasia (cancer plus advanced adenoma), and construction of panels of markers to discriminate between these groups. (2) To perform validation trials of promising biomarkers discovered by EDRN investigators, external collaborating institutions and collaborating EDRN industrial partners for the early detection of colorectal neoplasia. In this context we propose to (a) to clinically validate (via a methods comparison study) the performance of a point-of-care blood- based biomarker panel with the testing of serum/plasma samples obtained in clinics serving low-income and underserved communities and (b) to clinically validate an established 4-plex stool protein panel for early diagnosis of CRC. (3) To follow prospectively subjects enrolled in an established prospective Phase 2 validation trial to identify pre-diagnostic specimens which may be used to develop predictive markers.