Last updated on January 2019

Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma


Brief description of study

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.

Detailed Study Description

The clinical research associate or study nurse (hereafter "CRA") at each clinical site will identify subjects with appointments for screening colonoscopy via IRB-approved HIPAA-compliant site-specific methods (Appendix B-tailored to each site). Recruitment methods could include letters from the primary care physicians and gastroenterologists, direct referrals to the study team by physicians, in-clinic recruitment advertisements, and presentations. Interested subjects will be asked to participate in a baseline visit prior to initiation of colonoscopy preparative procedures, either at the local Center or during a visit to the subject's home by a CRA. Advertisements (e.g., newspapers, AARP Magazine, Clinicaltrials.gov) may also be used to recruit subjects from the surrounding communities.

Clinical Study Identifier: NCT01511653

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Recruitment Status: Open


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