A Randomized, Parallel-Group, Non-Inferiority Trial Comparing Random AND Targeted Biopsies to Targeted Biopsies Alone for Neoplasia Detection During Screening Colonoscopy in Adult Persons with Colonic Inflammatory Bowel Diseases: A Pilot Study (Short: “IBD-Dysplasia”)
PI: Sanjay Murthy, Ottawa Hospital Research Institute
Co-Investigators
Dr. Dean Fergusson, Ottawa Hospital Research Institute
Dr. Charles Bernstein, University of Manitoba
Dr. Geoffrey Nguyen, University of Toronto
Dr. Robert Riddell, University of Toronto
Dr. Vipul Jairath, Western University, London, Ontario
Dr. James Conner, University of Toronto
Purpose
To evaluate the feasibility of conducting a full-scale trial regarding the utility of interval random biopsies during neoplasia screening in colonic IBD (cIBD).
Study Design
We will conduct a multi-centre, parallel-group, non-inferiority RCT. Patients will be randomized 1:1 using a central randomization scheme, stratified by study site. The intervention group will comprise persons undergoing screening using HD-WLE with targeted sampling of visible lesions and the control group (standard of care) will comprise persons undergoing screening using HD-WLE with both random (32 to 40 interval random biopsies) and targeted sampling. Samples interpreted as having neoplasia will be shipped to Mount Sinai Hospital in Toronto for central adjudication. The primary metrics will be feasibility (recruitment, protocol violations, completion of documentation) for the pilot study and efficacy and safety (dysplasia, cancer) for the larger study.
Participating Sites
Ottawa Hospital Research Institute, ON
Mount Sinai Hospital, Toronto, ON
London Health Sciences Centre, ON
Hamilton Health Sciences Centre, ON
Thunder Bay Regional Health Sciences Centre, ON
Eastern Regional Health Authority, St. John’s, NL
Nova Scotia Health Authority, Halifax, NS
McGill University Health Centre, QC
Winnipeg Regional Health Authority – Health Sciences Centre
University of Alberta, Edmonton, AB
University of British Columbia; St. Paul’s Hospital/Providence Health Care
Pacific Digestive Health / Royal Jubilee Hospital, Victoria, BC
For more information on Inclusion & Exclusion Criteria, click here.
Targets
Anticipated sample size: 400 (PILOT); 2000 (FULL STUDY)
Anticipated start: Fall 2020
Anticipated end: Spring 2022 (PILOT); 2025 (FULL STUDY)
Additional sites are welcome! Please contact Sanjay Murthy at smurthy@toh.ca or Jane Castelli at jcast@mcmaster.ca.