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

Colorectal Neoplasms Clinical Trial

Official title:

Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623883
• Other study ID #: NNMC.1997.0091
• Status: Completed
• Phase: N/A
• First received: February 15, 2008
• Last updated: February 15, 2008
• Start date: January 1999
• Est. completion date: June 2007

Study information

• Verified date: June 2007
• Source: National Naval Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 -

Study Design

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

Related Conditions & MeSH terms

• Aberrant Crypt Foci
• Colorectal Neoplasms

Intervention

Procedure:
• Surgical removal of ACF
All ACF removed by either cold or hot colonoscopic biopsy forceps
• Colonoscopic evaluation only
Stain-enhanced magnification endoscopy performed, ACF quantified at entry and after one year

Locations

Country	Name	City	State
United States	National Naval Medical Center	Bethesda	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
National Naval Medical Center	National Cancer Institute (NCI), Uniformed Services University of the Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (2)

Glebov OK, Rodriguez LM, Nakahara K, Jenkins J, Cliatt J, Humbyrd CJ, DeNobile J, Soballe P, Simon R, Wright G, Lynch P, Patterson S, Lynch H, Gallinger S, Buchbinder A, Gordon G, Hawk E, Kirsch IR. Distinguishing right from left colon by the pattern of g — View Citation

Glebov OK, Rodriguez LM, Soballe P, DeNobile J, Cliatt J, Nakahara K, Kirsch IR. Gene expression patterns distinguish colonoscopically isolated human aberrant crypt foci from normal colonic mucosa. Cancer Epidemiol Biomarkers Prev. 2006 Nov;15(11):2253-62 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number, size, and location of ACF identified		initially and after one year	No
Secondary	complications of stain-enhanced, magnification colonoscopy		initially and after one year	Yes