Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma
5.0 STUDY DESIGN 5.1 Subject Recruitment 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.
Observational
Observational Model: Case Control, Time Perspective: Prospective
Compare biomarkers to colonoscopy as a predictor of CRC risk
To validate various biomarkers (stool, blood, urine, FIT) as predictive tools for assessing risk of CRC. Ultimately, these markers may increasing screening and compliance with screening recommendations of CRC by triaging those at higher risk of CRC by thesenon-invasive markers. Those at higher risk of CRC based on biomarker results would be referred for colonoscopy. The assumption is that compliance with colonoscopy would increase if biomarkers suggested an increased risk.
baseline
No
United States: Federal Government
GLNE010
NCT01511653
October 2011
Name | Location |
---|---|
University of Michigan | Ann Arbor, Michigan 48109-0624 |
University of Minnesota | Minneapolis, Minnesota 55455 |
University of Washington | Seattle, Washington 98195 |
Columbia University | New York, New York 10032-3784 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
M.D. Anderson Cancer Center | Houston, Texas 77030 |
Mt. Sinai School of Medicine | New York, New York 10029 |
University of Illinois-Chicago | Chicago, Illinois 60612 |