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.

大湖新英格兰临床验证中心（GLNE CVC），一个临床验证财团 早期检测研究网络（EDRN）的组成部分是一个高度协作的研究者小组 旨在验证生物标志物以对胃肠道癌的早期检测和风险评估进行验证 道。在第五次竞争应用中，GLNE继续检验了一个总体假设 循环和基于凳子的生物标志物将增加对结直肠筛查的依从性，并减少 结直肠癌引起的死亡率。基于成年人结直肠癌（CRC）的发病率上升 在美国，年龄<50岁，在服务不足的人群中的依从性低和高死亡率，重点越来越大 放在这些人群上。 Glne还建议继续其对Edrn Discovery的持续支持 优先事项。我们建议解决以下目的：（1）主要目的扩展和更新档案 适当保存的凳子，血清，血浆，尿液，组织和DNA生物测量可用于EDRN 当前和未来验证和生物标志物发现研究的研究者随着扩展的包括 患有早期CRC和服务不足的受试者。这将允许评估个人的效用 基于凳子的基于凳子，基于血清的生物标志物和生物标志物面板，用于区分没有 肿瘤（平均受试者的结肠癌风险和更高的风险），以及结肠癌的患者 或与筛查相关的肿瘤（癌症和晚期腺瘤），并建造标记面板 区分这些群体。 （2）执行EDRN发现的有前途的生物标志物的验证试验 调查人员，外部合作机构以及与EDRN工业合作伙伴合作进行早期检测 结直肠肿瘤。在这种情况下，我们建议（a）在临床上验证（通过方法比较研究） 使用血清/等离子体样品测试的基于血液的生物标志物面板的性能 在为低收入和服务不足的社区提供服务的诊所中获得的，（b）在临床上验证已建立的 4型粪便蛋白面板，用于早期诊断CRC。 （3）跟随前瞻性的受试者参加 已建立的前瞻性阶段验证试验，以识别诊断前标本，可用于 开发预测标记。