Inflammatory Bowel DiseasesURBINCT06560021
Utility of Random Biopsies in Patients With Inflammatory Bowel Disease
A study testing Biopsy strategy in people with Inflammatory Bowel Diseases and Crohn Disease, run by Abramson Cancer Center at Penn Medicine at 21 sites in United States.
Trial 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 (HDWLC) with targeted biopsies plus 2 random biopsies in 4 segments to assess for inflammation (limited biopsy strategy)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Biopsy strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,642 participants
- Where
- 21 sitesUnited States
- Study dates
- 3 Jan 2025to 30 Jun 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
United States21 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
Mercy Medical Center
Baltimore, Maryland, 21202
University of Alabama Birmingham
Birmingham, Alabama, 35233
University of North Carolina
Chapel Hill, North Carolina, 27599
Northwestern University
Chicago, Illinois, 60611
Houston Methodist Hospital
Houston, Texas, 77030
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
University of California, Los Angeles
Los Angeles, California, 90095
University of Miami
Miami, Florida, 33136
NYU Langone Health
New York, New York, 10016
Weill Cornell Medicine
New York, New York, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
AdventHealth
Orlando, Florida, 32804
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
University of Utah
Salt Lake City, Utah, 84112
Scripps Health
San Diego, California, 92121
About this study
Official title: A Randomized Trial of the Utility of Random Biopsies in Patients With Inflammatory Bowel Disease
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.
Read the 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 standing Inflammatory Bowel Disease (IBD) undergoing dysplasia and colorectal cancer (CRC) surveillance with high-definition white light colonoscopy (HDWLC). For this protocol, dysplasia surveillance refers to the process of identifying precancerous dysplasia, sessile serrated adenoma (SSA) or CRC. This protocol describes a pragmatic, multicenter randomized trial of patients with IBD undergoing dysplasia surveillance with HDWLC, the most common type of surveillance colonoscopy performed in the US, to definitively answer this question.
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:
- 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
- Determine whether the number of targeted biopsies differs based on the number of random biopsies obtained.
- Being tested
- Biopsy strategy
- Keywords
- IBD, UC, inflammatory bowel diseases, colonoscopy, random biopsies, Crohn's disease, ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy strategyOther
Number of random biopsies, in addition to targeted biopsies, taken during colonoscopies where at least one indication for the colonoscopy is surveillance for dysplasia
| Study group | Role | What they receive |
|---|---|---|
| Limited biopsy strategy | Active comparator | Targeted biopsies plus 2 random biopsies in 2 segments to assess for inflammation Receives: Other: Biopsy strategy |
| Random biopsy strategy | Active comparator | 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 Receives: Other: Biopsy strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of dysplastic or SSA lesions detected per 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.
Measured: At index colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start3 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter parallel group clinical trial
- Masking
- None (open label)
- Enrolment
- 1,642 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James D Lewis, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560021
- Sponsor's protocol ID
- 15225
- Other IDs
- U01DK138901
- Acronym
- URBI
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes