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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Study Completion Date

2007-06-30

Brief Summary

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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.

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Detailed Description

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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

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

All identified ACF eliminated by cold or hot colonoscopic biopsy forceps

Group Type EXPERIMENTAL

Surgical removal of ACF

Intervention Type PROCEDURE

All ACF removed by either cold or hot colonoscopic biopsy forceps

2

ACF quantified and observed, re-evaluated after one year

Group Type SHAM_COMPARATOR

Colonoscopic evaluation only

Intervention Type PROCEDURE

Stain-enhanced magnification endoscopy performed, ACF quantified at entry and after one year

Interventions

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Surgical removal of ACF

All ACF removed by either cold or hot colonoscopic biopsy forceps

Intervention Type PROCEDURE

Colonoscopic evaluation only

Stain-enhanced magnification endoscopy performed, ACF quantified at entry and after one year

Intervention Type PROCEDURE

Eligibility Criteria

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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 -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes