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RECRUITING
NCT05809999
NA

IBD Neoplasia Surveillance RCT

Sponsor: Ottawa Hospital Research Institute

View on ClinicalTrials.gov

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

PROCEDURE

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