RecruitingNot ApplicableNCT05809999

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

Sponsor

Ottawa Hospital Research Institute

Enrollment

1,952 participants

Start Date

Sep 23, 2022

Study Type

INTERVENTIONAL

Conditions

Inflammatory Bowel Diseases Colonic Neoplasms Dysplasia

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two colonoscopy techniques to detect colon cancer early in people who have had inflammatory bowel disease (IBD) for a long time. **You may be eligible if...** - You are 18 or older - You have had ulcerative colitis or Crohn's disease for 8 or more years - Your disease involves a significant portion of your colon - You are currently in remission (no active symptoms) - You are having a colonoscopy for cancer screening **You may NOT be eligible if...** - You have had colorectal cancer before - You have had more than half your colon removed - You recently had neoplasia (abnormal tissue) found on colonoscopy - Your bowel preparation was inadequate or your colonoscopy was incomplete Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStandard 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

View Full Details on ClinicalTrials.gov

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NCT05809999

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