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NCT06560021

Utility of Random Biopsies in Patients With Inflammatory Bowel Disease

Enrolling by Invitation
NAAges 18+InterventionalPrevention
Abramson Cancer Center at Penn Medicine
~1,642 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Biopsy strategy

At a glance

Recruiting sites
0 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
number of dysplastic or SSA lesions detected per colonoscopy
Measured over At index colonoscopy

Conditions

Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis

Explore related trials

Crohn DiseaseInflammatory Bowel DiseaseUlcerative Colitis

Where it's being run

20 sites across 13 states
Florida3
New York3
Pennsylvania3
California2
Alabama1
Colorado1
Illinois1
Maryland1

Study leadership

  • James D Lewis, MD, MSCE · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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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 (defined as 2 segments of the remaining colon; segments include right colon, transverse colon, left colon and rectum).
Disease duration must meet one of the following criteria:
Scheduled to undergo colonoscopy as part of routine care
At least one indication for the index colonoscopy must be to perform dysplasia surveillance.

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
Less than 2 segments of the remaining colon have ever been involved with IBD
Colonoscopy\* in the last 11 months unless the colonoscopy:
Inability to provide informed consent

What this trial measures

  • number of dysplastic or SSA lesions detected per colonoscopyAt index colonoscopy

    The rationale for this as the primary outcome is that it is important to detect and remove all precancerous lesions. For this outcome, the investigators will include low grade dysplasia (LGD), high grade dysplasia (HGD), SSA or CRC but not indefinite for dysplasia (IFD). Dysplasia will include both conventional and nonconventional forms of dysplasia. Although SSAs do not typically have histologic changes of dysplasia, they are considered precancerous lesions and are more difficult to detect than sporadic adenomatous polyps. The number of dysplastic or SSA lesions will be defined as the number of pathology jars containing a specimen with low-grade or high-grade dysplasia (including CRC) or serrated changes consistent with a sessile serrated adenoma-like change. Even if there are more than one biopsy sample in a jar with dysplasia or SSA, it will be counted as one location with dysplasia or SSA.