Clinical trial NCT00623883: Colonoscopic Removal of Aberrant Crypt Foci: a Prospective, Randomized, Blinded Trial
Official title: Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: Human Colonic Aberrant Crypt Foci
Lead sponsor: National Naval Medical Center
Sponsor class: FED
Collaborators: name: Uniformed Services University of the Health Sciences
name: National Cancer Institute (NCI)
First posted: 2008-02-26
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 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.

Eligibility criteria: 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 -

Primary outcomes:
measure: number, size, and location of ACF identified
timeFrame: initially and after one year
Secondary outcomes:
measure: complications of stain-enhanced, magnification colonoscopy
timeFrame: initially and after one year
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Naval Medical Center
state: Maryland
Study officials:
affiliation: National Naval Medical Center
name: Peter W. Soballe, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1158/1055-9965.EPI-05-0694.
citation: 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 gene expression. Cancer Epidemiol Biomarkers Prev. 2003 Aug;12(8):755-62.