Status:
ENROLLING_BY_INVITATION
Utility of Random Biopsies in Patients With Inflammatory Bowel Disease
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Inflammatory Bowel Diseases
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The proposed study is a multicenter parallel group clinical trial that will include 821 evaluable patients per group who will be randomly assigned to either high definition white light colonoscopy (HD...
Detailed Description
To maximize the yield of surveillance colonoscopy, minimize risk to patients, and deliver cost-effective care, it is imperative to resolve whether random biopsies are warranted for patients with long ...
Eligibility Criteria
Inclusion
- Diagnosis of left-sided (greater than 15 cm of disease but not beyond the splenic flexure) or extensive (extending beyond the splenic flexure) ulcerative colitis or IBD-U or colonic Crohn's disease involving at least 1/3 of the colon for at least 8 years
- Patients who are scheduled to undergo colonoscopy as part of routine care.
- At least one indication for the index colonoscopy must be to perform dysplasia surveillance.
- Has not had a colonoscopy in the last 11 months
Exclusion
- Any condition that the endoscopist feels is a contraindication to random biopsies
- History of visible (high or low grade) dysplasia not completely removed
- History of sessile serrated adenoma not completely removed
- History of colorectal cancer
- Any condition for which the endoscopist feels that pancolonic contrast or virtual chromoendoscopy is mandatory
- Inability to provide informed consent
Key Trial Info
Start Date :
December 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
1642 Patients enrolled
Trial Details
Trial ID
NCT06560021
Start Date
December 11 2024
End Date
June 30 2029
Last Update
November 6 2025
Active Locations (17)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35233
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
3
Scripps Health
San Diego, California, United States, 92121
4
University of Colorado
Aurora, Colorado, United States, 80045