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

This study has been completed.
Sponsor:
Collaborators:
Uniformed Services University of the Health Sciences
Information provided by:
National Naval Medical Center
ClinicalTrials.gov Identifier:
NCT00623883
First received: February 15, 2008
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Colorectal Neoplasms
Procedure: Surgical removal of ACF
Procedure: Colonoscopic evaluation only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention

Resource links provided by NLM:


Further study details as provided by National Naval Medical Center:

Primary Outcome Measures:
  • number, size, and location of ACF identified [ Time Frame: initially and after one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complications of stain-enhanced, magnification colonoscopy [ Time Frame: initially and after one year ] [ Designated as safety issue: Yes ]

Enrollment: 98
Study Start Date: January 1999
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 -
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00623883

Locations
United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
National Naval Medical Center
Uniformed Services University of the Health Sciences
Investigators
Principal Investigator: Peter W. Soballe, M.D. National Naval Medical Center
  More Information

Publications:
Responsible Party: Peter W. Soballe, CAPT, MC, USN, National Naval Medical Center
ClinicalTrials.gov Identifier: NCT00623883     History of Changes
Other Study ID Numbers: NNMC.1997.0091
Study First Received: February 15, 2008
Last Updated: February 15, 2008
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Naval Medical Center:
Human Colonic Aberrant Crypt Foci

Additional relevant MeSH terms:
Colorectal Neoplasms
Aberrant Crypt Foci
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on September 16, 2014