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

Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00623883

Enrollment

Registered

2008-02-26

Start date

1999-01-31

Completion date

2007-06-30

Last updated

2008-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

Human Colonic Aberrant Crypt Foci

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.

Interventions

PROCEDURESurgical removal of ACF

All ACF removed by either cold or hot colonoscopic biopsy forceps

PROCEDUREColonoscopic evaluation only

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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 -

Design outcomes

Primary

Measure	Time frame
number, size, and location of ACF identified	initially and after one year

Secondary

Measure	Time frame
complications of stain-enhanced, magnification colonoscopy	initially and after one year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026