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OpenTrials
Completed

NCT Number: NCT00623883

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

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Naval Medical Center

Bethesda, Maryland, 20889, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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 -

Treatment and study plan

Surgical removal of ACF

Procedure

All ACF removed by either cold or hot colonoscopic biopsy forceps

Colonoscopic evaluation only

Procedure

Stain-enhanced magnification endoscopy performed, ACF quantified at entry and after one year

Primary outcomes

  1. number, size, and location of ACF identified

    Time frame: initially and after one year

Secondary outcomes

  1. complications of stain-enhanced, magnification colonoscopy

    Time frame: initially and after one year

Sponsors and collaborators

Lead sponsor

National Naval Medical Center

Fed

Collaborators

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

Registry information

Official study title

Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention

Important dates

Study start
1999
Primary completion
2007
Study completion
2007
First posted
Feb 26, 2008
Registry last updated
Feb 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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