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

Not Applicable

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Procedure: Surgical removal of ACF; Procedure: Colonoscopic evaluation only

• Registration Number: NCT00623883
• Lead Sponsor: National Naval Medical Center

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.

Study Timeline

• Study Start: 1999-01
• Status Verified: 2007-06
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Study First Submitted: 2008-02-15
• Study First Submitted QC: 2008-02-15
• Last Update Submitted: 2008-02-15
• Study First Posted: 2008-02-26
• Last Update Posted: 2008-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

1. Dept.of Defense Healthcare Beneficiaries
2. Age 18 or over, non-pregnant
3. History of colorectal cancer or other indication for colonoscopic screening
4. At least half of large intestine remaining
5. No use of investigational or chemotherapeutic drugs within 6 mos. -

Exclusion Criteria

1. History suggesting familial colon cancer syndrome
2. < 6 mos since colon resection or since treatment for colon cancer
3. Anticipated colon surgery within one year of entry
4. Inability to participate in scheduled followup at one year
5. Medical or psychiatric condition which would make patient a poor candidate -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Surgical removal of ACF	All identified ACF eliminated by cold or hot colonoscopic biopsy forceps
2	Colonoscopic evaluation only	ACF quantified and observed, re-evaluated after one year

Primary Outcome Measures

Name	Time	Method
number, size, and location of ACF identified	initially and after one year

Secondary Outcome Measures

Name	Time	Method
complications of stain-enhanced, magnification colonoscopy	initially and after one year

Trial Locations

Locations (1)

National Naval Medical Center; 🇺🇸 Bethesda, Maryland, United States