Great Lakes New England Clinical Validation Center

五大湖新英格兰临床验证中心(GLNE CVC)，一个临床验证联盟 早期检测研究网络(EDRN)的组成部分是一个高度合作的调查小组 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记物 一条小路。在这第五个竞争性应用中，GLNE继续测试总体假设，即 循环和粪便生物标记物将增加对结直肠筛查的依从性，并在这样做的过程中减少 结直肠癌导致的死亡率。基于成人结直肠癌(CRC)发病率的上升 美国的50岁，以及服务不足的人群中的低依从性和高死亡率，越来越受到重视 被放在这些种群身上。GLNE还建议继续其对EDRN发现的持续支持 优先事项。我们建议实现以下目标：(1)主要目标是扩大和更新 EDRN使用的适当保存的粪便、血清、血浆、尿液、组织和DNA生物检验品 当前和未来验证和生物标记物发现研究的调查人员，扩大纳入 患有早发性结直肠癌和服务不足人群的受试者。这将允许评估个人的效用 基于粪便和血清的生物标记物和生物标记物面板，用于区分没有 肿瘤(患结肠癌的风险中等和较高的人)，以及结肠癌患者 或筛查相关肿瘤(癌症和晚期腺瘤)，以及构建标记物面板以 对这些群体进行区别对待。(2)对EDRN发现的有前景的生物标志物进行验证试验 调查人员、外部合作机构和EDRN行业合作伙伴早期发现 结直肠肿瘤。在这种情况下，我们建议(A)临床验证(通过方法比较研究) 一种基于血液护理点的生物标志物面板的性能与血清/血浆样本的测试 在为低收入和服务不足的社区提供服务的诊所获得，以及(B)在临床上验证已建立的 4-复合式粪便蛋白板早期诊断大肠癌。(3)跟踪预期登记的科目 建立了前瞻性第二阶段验证试验，以确定可能用于 开发预测性标记。

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.