Fact CheckerSign in

NCT06560021Enrolling by invitation

Utility of Random Biopsies in Patients With Inflammatory Bowel Disease

A Randomized Trial of the Utility of Random Biopsies in Patients With Inflammatory Bowel Disease

Source: ClinicalTrials.gov · Last updated 17 Aug 2026

Brief summary (registry, in English)

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 (HDWLC) with targeted biopsies plus 2 random biopsies in 4 segments to assess for inflammation (limited biopsy strategy) or HDWLC with 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, regardless of the extent of disease (random biopsy strategy). Participants will be followed until total proctocolectomy or the end of the study period to determine whether the two methods of surveillance colonoscopy are associated with detection of dysplasia or sessile serrated adenoma at follow-up colonoscopy. Follow-up via chart review may continue for up to 15 years from enrollment.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
1642 (estimated)
First submitted
15 Aug 2024
Start date
3 Jan 2025
Primary completion date
31 Dec 2028
Lead sponsor
Abramson Cancer Center at Penn Medicine
NCT number
NCT06560021

What you commit to

  • Study type: Interventional
  • Planned participants: 1642
  • From 3 Jan 2025 to the primary completion date, 31 Dec 2028
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • Less than 2 segments of the remaining colon have ever been involved with IBD
  • Colonoscopy\* in the last 11 months unless the colonoscopy:
    • was determined by the endoscopist to be insufficient for dysplasia surveillance and,
    • did not include a diagnosis of dysplasia or sessile serrated adenoma. \*Does not include sigmoidoscopy
  • Inability to provide informed consent

Who the study is looking for

  • 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:
    • onset of symptoms of IBD at least 8 years prior
    • diagnosis of IBD at least 8 years prior
    • diagnosis of IBD for any duration if other risk factors for colon cancer are present including: concomitant diagnosis of primary sclerosing cholangitis, personal history of dysplasia, sessile serrated adenoma or right sided hyperplastic polyps greater than 10mm in diameter, or a family history of colon cancer in a first degree relative or two second degree relatives.
  • Scheduled to undergo colonoscopy as part of routine care
  • At least one indication for the index colonoscopy must be to perform dysplasia surveillance.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
University of Colorado
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
Mercy Medical Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
University of Alabama Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
University of North Carolina
Coordinator of this site? Confirm its status
Chapel HillUnited StatesUnknown status
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Houston Methodist Hospital
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Mayo Clinic- Jacksonville
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
University of California, Los Angeles
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
University of Miami
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Weill Cornell Medicine
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
NYU Langone Health
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
AdventHealth
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
University of Pittsburgh
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status
Allegheny Health Network
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status
University of Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Mayo Clinic - Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status
Scripps Health
Coordinator of this site? Confirm its status
San DiegoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.