IBD Neoplasia Surveillance RCT

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Diseases; Colonic Neoplasms; Dysplasia
• Interventions: Procedure: Standard colonoscopy with targeted biopsies

• Registration Number: NCT05809999
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-23
• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-04-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1952

Inclusion Criteria

• Each potential participant must satisfy all of the following criteria to be enrolled in the study.

  • ≥ 18 years old

  • Historical endoscopic/histologic disease extending beyond the rectum in UC or involving ≥ 1/3 of colorectum in CD> 50% of colon present, with remaining colon meeting above minimum criteria for disease extent (beyond rectum in UC, ≥1/3 colorectum in CD)

  • cIBD ≥ 8 years duration (or at any time after diagnosis if a patient also has primary sclerosing cholangitis)

  • In symptomatic remission at time of colonoscopy

    • For CD: Harvey-Bradshaw Index < 541
    • For UC or IBDU: Partial Mayo Score ≤ 242

  • Major purpose of colonoscopy is neoplasia screening/surveillance

  • Undergoing colonoscopy with high-definition white light endoscopy

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Exclusion Criteria

• Persons who are unable to provide informed consent
• Persons with a history of colorectal cancer
• Persons with prior subtotal or total colectomy (>50% of colon removed)
• Persons undergoing repeat colonoscopy to follow-up on recently diagnosed neoplasia identified within the past year
• Persons undergoing pancolonic chromoendoscopy or pancolonic virtual chromoendoscopy
• Colon mucosa visibility deemed inadequate for surveillance after washing/suctioning (Boston Bowel Preparation Score of 0 or 1 in any segment)
• Incomplete colonoscopy (unable to reach cecum or terminal ileum [if no cecum])
• Moderate-to-severe inflammation (Mayo 2-3) involving ≥ 25% of colorectum or mild inflammation (Mayo 1) involving ≥ 50% of colorectum

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Intervention Group	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.

Primary Outcome Measures

Name	Time	Method
Proportion of persons with ≥ 1 neoplastic lesion detected	4 years

Secondary Outcome Measures

Name	Time	Method
Mean procedure time	4 years
Mean number of neoplastic lesions per person	4 years
Proportion of persons with ≥ 1 high grade dysplastic lesion or colorectal cancers detected	4 years
Mean # tissue samples per person	4 years
Mean # high grade dysplastic lesions or colorectal cancers per person	4 years
Proportion of persons referred for colectomy based on neoplastic findings	4 years
Rate of major adverse events within 2 weeks of procedure (as per pilot study)	4 years
CRC incidence over five years following study colonoscopy (obtained through patient linkage to provincial cancer registries five years following trial completion)	4 years
Mean time to next recommended surveillance examination	4 years

Trial Locations

Locations (11)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

University of Manitoba, Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada

Eastern Regional Health Authority; 🇨🇦 St. John's, NFLD, Canada

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

London Health Sciences Centre, University Hospital; 🇨🇦 London, Ontario, Canada

Nova Scotia Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada

Thunder Bay Regional Health Sciences Centre; 🇨🇦 Thunder Bay, Ontario, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada