Spots Global Cancer Trial Database for Colonoscopic Removal of Aberrant Crypt Foci: a Prospective, Randomized, Blinded Trial

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Trial Identification

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

Official Title: Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention

Study ID: NCT00623883

Conditions

Colorectal Neoplasms

Interventions

Surgical removal of ACF

Colonoscopic evaluation only

Study Description

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 Description: 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.