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Could skipping random biopsies during colonoscopy be just as safe for IBD patients?

NCT ID NCT05809999

Knowledge-focused Sponsor: Ottawa Hospital Research Institute 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study compares two ways of doing colonoscopy in people with inflammatory bowel disease (IBD) who are at higher risk for colon cancer. One method takes biopsies only from visible abnormal areas, while the other also takes random biopsies from normal-looking tissue. The goal is to see if the simpler approach misses any pre-cancerous growths. About 1,400 adults with IBD will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If skipping random biopsies proves non-inferior, future IBD surveillance could be faster and less invasive without missing dangerous growths.
What could go wrong
This is a non-inferiority trial, so it may show that skipping random biopsies misses some pre-cancerous lesions. Results may not apply to all IBD patients.

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

1,411 people

The number who actually took part.

Started

Sep 2022

Finished

Feb 2026

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 to 100 years

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: * Each potential participant must satisfy all of the following criteria to be enrolled in the study. * ≥ 18 years old * Historical endoscopic/histologic disease extending beyond the rectum in UC or involving ≥ 1/3 of colorectum in CD\> 50% of colon present, with remaining colon meeting above minimum criteria for disease extent (beyond rectum in UC, ≥1/3 colorectum in CD) * cIBD ≥ 8 years duration (or at any time after diagnosis if a patient also has primary sclerosing cholangitis) * In symptomatic remission at time of colonoscopy * For CD: Harvey-Bradshaw Index \< 541 * For UC or IBDU: Partial Mayo Score ≤ 242 * Major purpose of colonoscopy is neoplasia screening/surveillance * Undergoing colonoscopy with high-definition white light endoscopy Exclusion Criteria: * Persons who are unable to provide informed consent * Persons with a history of colorectal cancer * Persons with prior subtotal or total colectomy (\>50% of colon removed) * Persons undergoing repeat colonoscopy to follow-up on recently diagnosed neoplasia identified within the past year * Persons undergoing pancolonic chromoendoscopy or pancolonic virtual chromoendoscopy * Colon mucosa visibility deemed inadequate for surveillance after washing/suctioning (Boston Bowel Preparation Score of 0 or 1 in any segment) * Incomplete colonoscopy (unable to reach cecum or terminal ileum \[if no cecum\]) * Moderate-to-severe inflammation (Mayo 2-3) involving ≥ 25% of colorectum or mild inflammation (Mayo 1) involving ≥ 50% of colorectum

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Conditions

The condition(s) this trial relates to.

colonic neoplasm inflammatory bowel disease

As listed by the trial registrant

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

Colonic neoplasms Dysplasia Inflammatory bowel diseases

Contacts and locations

Locations

  • Eastern Regional Health Authority

    St. John's, NFLD, A1B 3V6, Canada

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L 8E7, Canada

  • London Health Sciences Centre, University Hospital

    London, Ontario, Canada

  • McGill University Health Centre

    Montreal, Quebec, Canada

  • Mount Sinai Hospital

    Toronto, Ontario, Canada

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, Canada

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6, Canada

  • St. Paul's Hospital

    Vancouver, British Columbia, Canada

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, Canada

  • University of Alberta

    Edmonton, Alberta, Canada

  • University of Manitoba, Health Sciences Centre

    Winnipeg, Manitoba, Canada

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