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Do extra biopsies during colonoscopy help IBD patients? major study aims to find out

NCT ID NCT06560021

Knowledge-focused Sponsor: Abramson Cancer Center at Penn Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This study looks at whether taking extra random biopsies during a colonoscopy helps find precancerous growths in people with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. About 1,600 participants will be randomly assigned to one of two biopsy methods and followed for up to 15 years. The goal is to improve cancer prevention while reducing unnecessary procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,642 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. onset of symptoms of IBD at least 8 years prior 2. diagnosis of IBD at least 8 years prior 3. 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. Exclusion Criteria: * 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: 1. was determined by the endoscopist to be insufficient for dysplasia surveillance and, 2. did not include a diagnosis of dysplasia or sessile serrated adenoma. \*Does not include sigmoidoscopy * Inability to provide informed consent

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Conditions

The condition(s) this trial relates to.

Crohn disease indeterminate colitis inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease Inflammatory bowel diseases Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth

    Orlando, Florida, 32804, United States

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15224, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Mercy Medical Center

    Baltimore, Maryland, 21202, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Scripps Health

    San Diego, California, 92121, United States

  • University of Alabama Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

  • Weill Cornell Medicine

    New York, New York, 10021, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.