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
- Diseases
- Crohn's disease, Ulcerative colitis
- 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
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Mercy Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Alabama Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| AdventHealth Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Allegheny Health Network Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Scripps Health Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.