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Completed

NCT Number: NCT05809999

IBD Neoplasia Surveillance RCT

We will conduct a multicenter, parallel-group, non-inferiority RCT in persons with IBD undergoing colorectal neoplasia screening with high-definition white light colonoscopy, comparing a strategy of sampling visible lesions alone to a conventional strategy of sampling both visible lesions as well as normal-appearing mucosa using non-targeted biopsies. The primary outcome is the neoplasia detection rate. The required sample size to demonstrate non-inferiority is 1952 persons.

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Key information

Conditions

Colonic Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Dysplasia Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard colonoscopy with targeted biopsies

Procedure

Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy targeted biopsies (biopsies of any pre-cancerous lesions observed by the doctor) and/or removal of any polyps will be undertaken.

Primary outcomes

  1. Proportion of persons with ≥ 1 neoplastic lesion detected

    Time frame: 4 years

Secondary outcomes

  1. Mean number of neoplastic lesions per person

    Time frame: 4 years

  2. Proportion of persons with ≥ 1 high grade dysplastic lesion or colorectal cancer

    Time frame: 4 years

  3. Mean # high grade dysplastic lesions or colorectal cancers per person

    Time frame: 4 years

  4. Mean # non-targeted (random) biopsies per person

    Time frame: 4 years

  5. Mean procedure time

    Time frame: 4 years

  6. Rate of major adverse events within 2 weeks of procedure (as per pilot study)

    Time frame: 4 years

  7. Mean time to next recommended surveillance examination

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

A Randomized Controlled Non-Inferiority Trial Comparing Neoplasia Detection During Colonoscopy Screening With and Without Non-Targeted Biopsies in Adult Colonic Inflammatory Bowel Disease

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 12, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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