Status:

COMPLETED

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

Lead Sponsor:

National Naval Medical Center

Collaborating Sponsors:

Uniformed Services University of the Health Sciences

National Cancer Institute (NCI)

Conditions:

Colorectal Neoplasms

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 t...

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 perso...

Eligibility Criteria

Inclusion

  • 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

  • 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 -

Key Trial Info

Start Date :

January 1 1999

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2007

Estimated Enrollment :

98 Patients enrolled

Trial Details

Trial ID

NCT00623883

Start Date

January 1 1999

End Date

June 1 2007

Last Update

February 26 2008

Active Locations (1)

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National Naval Medical Center

Bethesda, Maryland, United States, 20889