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

February 15, 2008 updated by: National Naval Medical Center

Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • National Naval Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Naval Medical Center

Collaborators

National Cancer Institute (NCI)
Uniformed Services University of the Health Sciences

Investigators

  • Principal Investigator: Peter W. Soballe, M.D., National Naval Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

February 15, 2008

First Submitted That Met QC Criteria

February 15, 2008

First Posted (Estimate)

February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

February 26, 2008

Last Update Submitted That Met QC Criteria

February 15, 2008

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NNMC.1997.0091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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