NCT05809999Completed
IBD Neoplasia Surveillance RCT
A Randomized Controlled Non-Inferiority Trial Comparing Neoplasia Detection During Colonoscopy Screening With and Without Non-Targeted Biopsies in Adult Colonic Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1411 (actual)
- First submitted
- 30 Mar 2023
- Start date
- 23 Sept 2022
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- Ottawa Hospital Research Institute
- Diseases
- Colorectal cancer
- NCT number
- NCT05809999
What you commit to
- Study type: Interventional
- Participants enrolled: 1411
- From 23 Sept 2022 to the primary completion date, 28 Feb 2026
- 11 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.
Prior treatment
- Persons with prior subtotal or total colectomy (\>50% of colon removed)
Other illness
- Persons with a history of colorectal cancer
Other
- Persons who are unable to provide informed consent
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Nova Scotia Health Authority Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Hamilton Health Sciences Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| London Health Sciences Centre, University Hospital Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Ottawa Hospital Research Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Eastern Regional Health Authority Coordinator of this site? Confirm its status | St. John's | Canada | Unknown status |
| Thunder Bay Regional Health Sciences Centre Coordinator of this site? Confirm its status | Thunder Bay | Canada | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| St. Paul's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| University of Manitoba, Health Sciences Centre Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.