Clinical Trial: Colonoscopic Removal of Aberrant Crypt Foci: a Prospective, Randomized, Blinded Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention

Brief Summary: We hypothesized that aberrant crypt foci (ACF) are precursors of colon cancer; their prevention would correlate with cancer risk and their elimination would reduce that risk. In this study we wished to (1) establish the feasibility of stain-enhanced magnification colonoscopy, (2) determine whether colorectal cancer is asociated with increased numbers of ACF, and (3) investigate the natural history of ACF and the durability of their elimination.

Detailed Summary: Subjects are randomly assigned at the time of stain-enhanced magnification colonoscopy to have any ACF removed or merely observed. Subjects are evenly divided into those with and those without a personal history of colon cancer. ACF are tabulated by an observer blinded to the subject's personal history. All subjects are then re-evaluated after one year by an observer blinded to the original procedure.
Sponsor: National Naval Medical Center

Current Primary Outcome: number, size, and location of ACF identified [ Time Frame: initially and after one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: complications of stain-enhanced, magnification colonoscopy [ Time Frame: initially and after one year ]

Original Secondary Outcome: Same as current

Information By: National Naval Medical Center

Dates:
Date Received: February 15, 2008
Date Started: January 1999
Date Completion:
Last Updated: February 15, 2008
Last Verified: June 2007