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Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention

18 Years
Not Enrolling
Colorectal Neoplasms

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Trial Information

Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention

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.

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 -

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

number, size, and location of ACF identified

Outcome Time Frame:

initially and after one year

Safety Issue:


Principal Investigator

Peter W. Soballe, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Naval Medical Center


United States: Federal Government

Study ID:




Start Date:

January 1999

Completion Date:

June 2007

Related Keywords:

  • Colorectal Neoplasms
  • Human Colonic Aberrant Crypt Foci
  • Neoplasms
  • Colorectal Neoplasms
  • Aberrant Crypt Foci



National Naval Medical Center Bethesda, Maryland  20889