Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma

The investigators are undertaking a multi-center, 13000 subject validation study of several biomarkers for early detection of colon cancer. There are stool based biomarkers and blood based biomarkers being validated in this study. The biomarkers will be compared with colonoscopy and with FIT (fecal immunohistochemistry) tests which are the current standards for colon cancer screening. This is an NCI-early Detection Research Network funded project. The population targeted for this study are those persons undergoing colonoscopy for screening. Prior to colonoscopy or even prepping for colonoscopy, subjects will provide blood and stool samples as well as specific data regarding their GI and general medical history and concomitant medications. If subjects are interested in participating, arrangements will be made to see them. The informed consent process will take place, blood will be obtained, data will be obtained, and the stool kit described and given to the subject to take home. Stool samples will be sent back to the University of Michigan using prepaid mailing labels.

本研究团队正在开展一项多中心、纳入13000名受试者的结直肠癌早期检测多生物标志物验证研究。本研究将对粪便源生物标志物与血液源生物标志物进行验证，并以结肠镜检查与目前结直肠癌筛查的金标准FIT（粪便免疫化学试验，fecal immunohistochemistry）作为对照，对上述生物标志物的性能进行评估。本项目由NCI早期检测研究网络（NCI-Early Detection Research Network）资助。本研究的目标人群为接受结直肠癌筛查结肠镜检查的受试者。在结肠镜检查前甚至肠道准备前，受试者需提供血液与粪便样本，并填写有关胃肠道（gastrointestinal, GI）病史、全身病史以及合并用药情况的详细资料。若受试者有意参与本研究，将安排专人对接相关事宜。研究团队将完成知情同意流程，采集血液样本与受试者相关数据，并向受试者发放粪便采集套件以供带回家使用。受试者可使用预付费邮寄标签将粪便样本寄回密歇根大学。