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

Study Overview
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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.

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.

Official Title
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Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Procedure: Surgical removal of ACF
* Procedure: Colonoscopic evaluation only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dept.of Defense Healthcare Beneficiaries Age 18 or over, non-pregnant History of colorectal cancer or other indication for colonoscopic screening At least half of large intestine remaining No use of investigational or chemotherapeutic drugs within 6 mos. - Exclusion Criteria: History suggesting familial colon cancer syndrome < 6 mos since colon resection or since treatment for colon cancer Anticipated colon surgery within one year of entry Inability to participate in scheduled followup at one year Medical or psychiatric condition which would make patient a poor candidate -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>All identified ACF eliminated by cold or hot colonoscopic biopsy forceps | Procedure: Surgical removal of ACF<br>* All ACF removed by either cold or hot colonoscopic biopsy forceps<br>|
| Sham Comparator: 2<br>ACF quantified and observed, re-evaluated after one year | Procedure: Colonoscopic evaluation only<br>* Stain-enhanced magnification endoscopy performed, ACF quantified at entry and after one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number, size, and location of ACF identified |  | initially and after one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications of stain-enhanced, magnification colonoscopy |  | initially and after one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Colonic Aberrant Crypt Foci