Utility of Random Biopsies in Patients With Inflammatory Bowel Disease
NCT ID: NCT06560021
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
1642 participants
INTERVENTIONAL
2024-12-11
2029-06-30
Brief Summary
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Detailed Description
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The primary objective of the study is to determine if HDWLC using a limited biopsy strategy is non-inferior to HDWLC using a random biopsy strategy to detect dysplasia or sessile serrated adenoma (SSA) in patients with IBD.
Secondary objectives include:
1. Determine if HDWLC using a limited biopsy strategy is superior to HDWLC with a random biopsy strategy to detect one or more dysplastic or SSA lesion in patients with IBD
2. Determine whether the number of targeted biopsies differs based on the number of random biopsies obtained.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Limited biopsy strategy
Targeted biopsies plus 2 random biopsies in 2 segments to assess for inflammation
Biopsy strategy
Number of random biopsies, in addition to targeted biopsies, taken during colonoscopies where at least one indication for the colonoscopy is surveillance for dysplasia
Random biopsy strategy
Targeted biopsies plus 4 biopsies every 10 cm throughout the colon, at a minimum in all segments of the colon known to have been affected by IBD at any time
Biopsy strategy
Number of random biopsies, in addition to targeted biopsies, taken during colonoscopies where at least one indication for the colonoscopy is surveillance for dysplasia
Interventions
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Biopsy strategy
Number of random biopsies, in addition to targeted biopsies, taken during colonoscopies where at least one indication for the colonoscopy is surveillance for dysplasia
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Principal Investigators
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James D Lewis, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
University of California, Los Angeles
Los Angeles, California, United States
Scripps Health
San Diego, California, United States
University of Colorado
Aurora, Colorado, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
AdventHealth
Orlando, Florida, United States
Northwestern University
Chicago, Illinois, United States
Mercy Medical Center
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
NYU Langone Health
New York, New York, United States
University of Rochester
Rochester, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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15225
Identifier Type: -
Identifier Source: org_study_id