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

NCT00623883 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2008-02-26

No results posted yet for this study

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.

Conditions

  • Colorectal Neoplasms

Interventions

PROCEDURE

Surgical removal of ACF

All ACF removed by either cold or hot colonoscopic biopsy forceps

PROCEDURE

Colonoscopic evaluation only

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

Sponsors & Collaborators

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Naval Medical Center

    lead FED

Principal Investigators

  • Peter W. Soballe, M.D. · National Naval Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-01-31
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00623883 on ClinicalTrials.gov