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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00623883
First Posted: February 26, 2008
Last Update Posted: February 26, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Uniformed Services University of the Health Sciences
National Cancer Institute (NCI)
Information provided by:
National Naval Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
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
First Submitted: February 15, 2008
First Posted: February 26, 2008
Last Update Posted: February 26, 2008
Last Verified: June 2007

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