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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
National Cancer Institute (NCI)
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

February 15, 2008
February 15, 2008
January 1999
June 2007   (final data collection date for primary outcome measure)
number, size, and location of ACF identified [ Time Frame: initially and after one year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
complications of stain-enhanced, magnification colonoscopy [ Time Frame: initially and after one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Colonoscopic Removal of Aberrant Crypt Foci: a Prospective, Randomized, Blinded Trial
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Colorectal Neoplasms
  • Procedure: Surgical removal of ACF
    All ACF removed by either cold or hot colonoscopic biopsy forceps
  • Procedure: Colonoscopic evaluation only
    Stain-enhanced magnification endoscopy performed, ACF quantified at entry and after one year
  • Experimental: 1
    All identified ACF eliminated by cold or hot colonoscopic biopsy forceps
    Intervention: Procedure: Surgical removal of ACF
  • Sham Comparator: 2
    ACF quantified and observed, re-evaluated after one year
    Intervention: Procedure: Colonoscopic evaluation only

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
June 2007
June 2007   (final data collection date for primary outcome measure)

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 -
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00623883
NNMC.1997.0091
Yes
Peter W. Soballe, CAPT, MC, USN, National Naval Medical Center
National Naval Medical Center
  • Uniformed Services University of the Health Sciences
  • National Cancer Institute (NCI)
Principal Investigator: Peter W. Soballe, M.D. National Naval Medical Center
National Naval Medical Center
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP