Great Lakes New England Clinical Validation Center

新英格兰五大湖临床验证中心

基本信息

批准号：
10698103
负责人：
ROBERT S BRESALIER
金额：
$ 101.69万
依托单位：
UNIVERSITY OF TX MD ANDERSON CAN CTR
依托单位国家：
美国
项目类别：
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/10698103
关键词：
Address Adenocarcinoma Adherence Adult African American population Age Archives Biological Markers Blood Clinic Clinical Clinical Data Collaborations Colon 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 biomarker discovery biomarker panel biomarker validation 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

项目摘要

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。

项目成果

期刊论文数量（27）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Preferential isolation of fragmented DNA enhances the detection of circulating mutated k-ras DNA.

优先分离 DNA 片段可增强循环突变 k-ras DNA 的检测。

DOI：
发表时间：
2004-01
期刊：
影响因子：
9.3
作者：
Wang, Mengjun;Block, Timothy M;Steel, Laura;Brenner, Dean E;Su, Ying
通讯作者：
Su, Ying

Detecting K-ras mutations in stool from fecal occult blood test cards in multiphasic screening for colorectal cancer.

在结直肠癌多相筛查中通过粪便潜血检测卡检测粪便中的 K-ras 突变。

DOI：
10.1016/j.canlet.2007.01.023
发表时间：
2007-08-18
期刊：
Cancer letters
影响因子：
9.7
作者：
G. Rennert;D. Kislitsin;D. Brenner;H. Rennert;Z. Lev
通讯作者：
Z. Lev

Detection of a K-ras mutation in urine of patients with colorectal cancer.

结直肠癌患者尿液中 K-ras 突变的检测。

DOI：
发表时间：
2005
期刊：
影响因子：
0
作者：
Su, Ying;Wang, Mengjun;Aiamkitsumrit, Benjamas;Brenner, Dean E;Block, Timothy M
通讯作者：
Block, Timothy M

Missed adenomas during colonoscopic surveillance in individuals with Lynch Syndrome (hereditary nonpolyposis colorectal cancer).

在林奇综合征（遗传性非息肉病性结直肠癌）个体的结肠镜监测中遗漏了腺瘤。

DOI：
发表时间：
2008-11
期刊：
影响因子：
0
作者：
Stoffel, Elena M;Turgeon, D Kim;Stockwell, David H;Zhao, Lili;Normolle, Daniel P;Tuck, Missy K;Bresalier, Robert S;Marcon, Norman E;Baron, John A;Ruffin, Mack T;Brenner, Dean E;Syngal, Sapna;Great Lakes
通讯作者：
Great Lakes

Detection of mutated K-ras DNA in urine, plasma, and serum of patients with colorectal carcinoma or adenomatous polyps.

检测结直肠癌或腺瘤性息肉患者的尿液、血浆和血清中突变的 K-ras DNA。