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
1 other identifier
interventional
1,411
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2022
CompletedFirst Submitted
Initial submission to the registry
March 30, 2023
CompletedFirst Posted
Study publicly available on registry
April 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedJuly 7, 2026
July 1, 2026
3.4 years
March 30, 2023
July 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of persons with ≥ 1 neoplastic lesion detected
4 years
Secondary Outcomes (7)
Mean number of neoplastic lesions per person
4 years
Proportion of persons with ≥ 1 high grade dysplastic lesion or colorectal cancer
4 years
Mean # high grade dysplastic lesions or colorectal cancers per person
4 years
Mean # non-targeted (random) biopsies per person
4 years
Mean procedure time
4 years
- +2 more secondary outcomes
Study Arms (2)
Experimental: Intervention Group
EXPERIMENTALParticipants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy targeted biopsies (biopsies of any areas suspicious for neoplastic/dysplastic lesions observed by the doctor) and/or removal of any polyps will be undertaken. A limited number of disease staging biopsies from each segment of the colorectum will be permitted.
Control Group
NO INTERVENTIONParticipants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy both random (approximately 32 to 40 non-targeted biopsies) and targeted sampling (biopsies and/or removal of suspicious pre-cancerous lesions) will be undertaken.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of Alberta
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
University of Manitoba, Health Sciences Centre
Winnipeg, Manitoba, Canada
Eastern Regional Health Authority
St. John's, NFLD, A1B 3V6, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Hamilton Health Sciences
Hamilton, Ontario, L8L 8E7, Canada
London Health Sciences Centre, University Hospital
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2023
First Posted
April 12, 2023
Study Start
September 23, 2022
Primary Completion
February 28, 2026
Study Completion
February 28, 2026
Last Updated
July 7, 2026
Record last verified: 2026-07