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

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgical removal of ACF
Colonoscopic evaluation only
Sponsored by
National Naval Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Neoplasms focused on measuring Human Colonic Aberrant Crypt Foci

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

  • National Naval Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

All identified ACF eliminated by cold or hot colonoscopic biopsy forceps

ACF quantified and observed, re-evaluated after one year

Outcomes

Primary Outcome Measures

number, size, and location of ACF identified

Secondary Outcome Measures

complications of stain-enhanced, magnification colonoscopy

Full Information

First Posted
February 15, 2008
Last Updated
February 15, 2008
Sponsor
National Naval Medical Center
Collaborators
Uniformed Services University of the Health Sciences, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00623883
Brief Title
Colonoscopic Removal of Aberrant Crypt Foci: a Prospective, Randomized, Blinded Trial
Official Title
Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Human Colonic Aberrant Crypt Foci

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
All identified ACF eliminated by cold or hot colonoscopic biopsy forceps
Arm Title
2
Arm Type
Sham Comparator
Arm Description
ACF quantified and observed, re-evaluated after one year
Intervention Type
Procedure
Intervention Name(s)
Surgical removal of ACF
Intervention Description
All ACF removed by either cold or hot colonoscopic biopsy forceps
Intervention Type
Procedure
Intervention Name(s)
Colonoscopic evaluation only
Intervention Description
Stain-enhanced magnification endoscopy performed, ACF quantified at entry and after one year
Primary Outcome Measure Information:
Title
number, size, and location of ACF identified
Time Frame
initially and after one year
Secondary Outcome Measure Information:
Title
complications of stain-enhanced, magnification colonoscopy
Time Frame
initially and after one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Dept.of Defense Healthcare Beneficiaries Age 18 or over, non-pregnant History of colorectal cancer or other indication for colonoscopic screening At least half of large intestine remaining No use of investigational or chemotherapeutic drugs within 6 mos. - Exclusion Criteria: History suggesting familial colon cancer syndrome < 6 mos since colon resection or since treatment for colon cancer Anticipated colon surgery within one year of entry Inability to participate in scheduled followup at one year Medical or psychiatric condition which would make patient a poor candidate -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter W. Soballe, M.D.
Organizational Affiliation
National Naval Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Naval Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17119054
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.
Results Reference
result
PubMed Identifier
12917207
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.
Results Reference
result

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

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