Great Lakes New England Clinical Validation Center

新英格兰五大湖临床验证中心

• 批准号: 10484455
• 负责人: ROBERT S BRESALIER
• 金额: $ 80.4万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-05-15 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10484455
• 关键词: Address; Adenocarcinoma; Adherence; Adult; African American population; Age; Archives; Biological Markers; Blood; Clinic; Clinical; Clinical Data; Colon Carcinoma; Colonoscopy; Colorectal; Colorectal Cancer; Colorectal Neoplasms; DNA; Development; Diagnostic; Early Detection Research Network; Early Diagnosis; Enrollment; Feces; Future; High grade dysplasia; Incidence; Individual; Industrialization; Institution; Link; Low income; Malignant Neoplasms; Malignant neoplasm of gastrointestinal tract; Methods; Morbidity - disease rate; Neoplasms; New England; Participant; Patients; Performance; Phase; Plasma; Population; Prevalence; Procedures; Proteins; Research; Research Personnel; Risk Assessment; Sampling; Serum; Specimen; Testing; Tissues; Tubulovillous Adenoma; Underserved Population; Urine; Validation; Villous Adenoma; adenoma; base; biomarker discovery; biomarker panel; blood-based biomarker; candidate marker; circulating biomarkers; colorectal cancer screening; cost; early detection biomarkers; early onset colorectal cancer; follow-up; high risk; mortality; point of care; predictive marker; preservation; prospective; response; sample collection; screening; sex; stool sample; underserved community

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.

新英格兰五大湖临床验证中心 (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协作的研究人员小组 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。在第五个竞争性应用中，GLNE 继续测试总体假设，即一组 基于循环和粪便的生物标志物将提高结直肠筛查的依从性，从而减少 结直肠癌引起的死亡。基于成人结直肠癌 (CRC) 发病率的上升 在美国，年龄 <50 岁的人群以及服务不足人群的低依从性和高死亡率，引起了越来越多的重视 被放置在这些人群上。 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 扩大和更新档案 适当保存的粪便、血清、血浆、尿液、组织和 DNA 生物样本供 EDRN 使用 研究人员进行当前和未来的验证和生物标志物发现研究，并扩大了 患有早发性结直肠癌的受试者和服务不足的人群。这将允许评估个人的效用 基于粪便和基于血清的生物标志物和生物标志物组，用于区分个体而无需 肿瘤（罹患结肠癌的平均风险和较高风险的受试者）以及患有结肠癌的受试者 或筛查相关肿瘤（癌症加晚期腺瘤），以及构建标记物组 区分这些群体。 (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） 即时检测血液生物标志物组与血清/血浆样本测试的性能 在为低收入和服务不足的社区提供服务的诊所中获得，并且（b）临床验证已建立的 用于早期诊断 CRC 的 4 重粪便蛋白组合。 (3) 前瞻性地跟踪参加研究的受试者 建立了前瞻性 2 期验证试验，以确定可用于诊断的预诊断样本 开发预测标记。