NCT00274209

Brief Summary

Long-standing ulcerative colitis is associated with an increased cancer risk. Chromoendoscopy with dye spraying can detect subtle abnormalities that are not visible with standard endoscopy. The purpose of this study is to determine if chromoendoscopy with fewer "targeted biopsies" can replace standard colonoscopy with multiple "random" biopsies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2005

Longer than P75 for all trials

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

December 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2006

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

5.9 years

First QC Date

January 6, 2006

Last Update Submit

November 21, 2011

Conditions

Ulcerative ColitisCrohn's Disease

Keywords

Ulcerative colitisCrohn's diseaseChromoendoscopyDysplasiaNeoplasia

Outcome Measures

Primary Outcomes (1)

  • Prevalence of dysplastic lesions by white light vs. chromoendoscopy

    12 months

Study Arms (1)

IBD patients at risk for neoplasia

Patients with long-standing ulcerative colitis or Crohn's colitis at risk for neoplasia.

Procedure: Chromoendoscopy with magnification

Interventions

Chromoendoscopy with magnificationPROCEDURE

A blue dye (indigo carmine) will be sprayed prior to imaging the bowel lining using a zoom colonoscope. The dye is not absorbed and is safe for human use.

IBD patients at risk for neoplasia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ulcerative colitis satisfying criteria for surveillance colonoscopy

You may qualify if:

  • Ulcerative colitis, pancolitis \> 8 years; left-sided \> 15 years or
  • history of PSC or
  • history of previous dysplasia on colon biopsies or
  • family history of colon cancer in first degree relative

You may not qualify if:

  • any condition that precludes colonoscopy
  • expected survival less than 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

endoscopic biopsies

MeSH Terms

Conditions

Colitis, UlcerativeCrohn DiseaseNeoplasms

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Michael V Chiorean, MD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

January 6, 2006

First Posted

January 10, 2006

Study Start

December 1, 2005

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 22, 2011

Record last verified: 2011-11

Locations

US(1)