NCT00623883

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
Last Updated

February 26, 2008

Status Verified

June 1, 2007

Enrollment Period

8.4 years

First QC Date

February 15, 2008

Last Update Submit

February 15, 2008

Conditions

Colorectal Neoplasms

Keywords

Human Colonic Aberrant Crypt Foci

Outcome Measures

Primary Outcomes (1)

  • number, size, and location of ACF identified

    initially and after one year

Secondary Outcomes (1)

  • complications of stain-enhanced, magnification colonoscopy

    initially and after one year

Study Arms (2)

1

EXPERIMENTAL

All identified ACF eliminated by cold or hot colonoscopic biopsy forceps

Procedure: Surgical removal of ACF

2

SHAM COMPARATOR

ACF quantified and observed, re-evaluated after one year

Procedure: Colonoscopic evaluation only

Interventions

Surgical removal of ACFPROCEDURE

All ACF removed by either cold or hot colonoscopic biopsy forceps

1
Colonoscopic evaluation onlyPROCEDURE

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Naval Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (2)

  • 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.

    PMID: 17119054RESULT

  • 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.

    PMID: 12917207RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Peter W. Soballe, M.D.

    National Naval Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 26, 2008

Study Start

January 1, 1999

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 26, 2008

Record last verified: 2007-06

Locations

US(1)