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Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma

50 Years
80 Years
Open (Enrolling)
Colon Cancer, Rectal Cancer

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Trial Information

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, may also be used to
recruit subjects from the surrounding communities.

Inclusion Criteria:

- Adults 50-80 and undergoing a colonoscopy defined as:

- First time screening or a surveillance procedure

- No complete colon exam (colonoscopy or CT colonography) within 3 years except
as noted. (see section 5.4.1)

- Willing to sign informed consent

- Able to physically tolerate removal of 34ml of blood

- Willing to collect 2 stool samples

Exclusion Criteria:

- Inability to provide informed consent

- History of Inflammatory Bowel Disease

- Overt rectal bleeding within 1 month (30 days) (including due to suspected

- Positive guaiac-based occult blood or fecal immunochemical test (e.g. FOBT, FIT) in
the past 12 months (365 days)

- Undergone resection of the colon for any indication

- Subjects with known HIV or chronic viral hepatitis (Hepatitis B and C)

- Subjects with known or suspected HNPCC (Lynch Syndrome) or FAP

- Any cancer within 5 years of enrollment except any of the following:

- Squamous cell carcinoma of the skin or Basal cell carcinoma of the skin

- Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell
carcinoma of the cervix treated by surgery only. (Excluded if had pelvic

- Stage , 0, I or Ia Grade 1 adenocarcinoma of the endometrium treated with

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Compare biomarkers to colonoscopy as a predictor of CRC risk

Outcome Description:

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.

Outcome Time Frame:


Safety Issue:



United States: Federal Government

Study ID:




Start Date:

October 2011

Completion Date:

Related Keywords:

  • Colon Cancer
  • Rectal Cancer
  • screening colonoscopy
  • colon cancer early detection
  • rectal cancer early detection
  • colorectal cancer prevention
  • biomarker validation
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms



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