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IBD Neoplasia Surveillance RCT
Sponsor: Ottawa Hospital Research Institute
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.
Official 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
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
1952
Start Date
2022-09-23
Completion Date
2026-02-28
Last Updated
2024-04-03
Healthy Volunteers
No
Interventions
Standard colonoscopy with targeted biopsies
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.
Locations (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, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
London Health Sciences Centre, University Hospital
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada