NCT00623883

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

Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: National Naval Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Surgical removal of ACF	All ACF removed by either cold or hot colonoscopic biopsy forceps
PROCEDURE	Colonoscopic evaluation only	Stain-enhanced magnification endoscopy performed, ACF quantified at entry and after one year

Timeline

• Start date: 1999-01-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2008-02-26
• Last updated: 2008-02-26

Locations

1 site across 1 country: United States