NCT05809999

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,952 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colonic Neoplasms
• Inflammatory Bowel Diseases
• Dysplasia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-23
• Primary completion: 2025-12-31
• Completion: 2026-02-28
• First posted: 2023-04-12
• Last updated: 2024-04-03

Locations

11 sites across 1 country: Canada