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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Colonic Neoplasms; Dysplasia
• Intervention / Treatment: Procedure: Standard colonoscopy with targeted biopsies

• Study Type: Interventional
• Enrollment (Estimated): 1952
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sanjay Murthy, MD; Phone Number: 73542 (613)737-8899; Email: smurthy@toh.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Recruiting
      • University of Alberta
      • Principal Investigator: Frank Hoentjen
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Recruiting
      • St. Paul's Hospital
      • Principal Investigator: Brian Bressler
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Recruiting
      • University of Manitoba, Health Sciences Centre
      • Principal Investigator: Charles Bernstein
  • NFLD
    • St. John's, NFLD, Canada, A1B 3V6
      • Recruiting
      • Eastern Regional Health Authority
      • Principal Investigator: Mark Borgaonkar
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Recruiting
      • Nova Scotia Health Authority
      • Principal Investigator: Jennifer Jones
  • Ontario
    • Hamilton, Ontario, Canada, L8L 8E7
      • Recruiting
      • Hamilton Health Sciences
      • Contact: Jane Castelli; Phone Number: 289-880-3609; Email: jcast@mcmaster.ca
      • Principal Investigator: Neeraj Narula, MD
    • London, Ontario, Canada
      • Recruiting
      • London Health Sciences Centre, University Hospital
      • Principal Investigator: Vipul Jairath
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • Ottawa Hospital Research Institute
      • Principal Investigator: Sanjay Murthy
    • Thunder Bay, Ontario, Canada
      • Recruiting
      • Thunder Bay Regional Health Sciences Centre
      • Principal Investigator: Petros Zezos
    • Toronto, Ontario, Canada
      • Recruiting
      • Mount Sinai Hospital
      • Principal Investigator: Geoff Nguyen
  • Quebec
    • Montreal, Quebec, Canada
      • Recruiting
      • McGill University Health Centre
      • Principal Investigator: Talat Bessissow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Intervention Group; 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.	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.
No Intervention: Control Group; Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy both random (approximately 32 to 40) and targeted biopsies (and/or removal of any polyps) will be undertaken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of persons with ≥ 1 neoplastic lesion detected	4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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 # high grade dysplastic lesions or colorectal cancers per person	4 years
Mean # tissue samples per person	4 years
Mean procedure time	4 years
Rate of major adverse events within 2 weeks of procedure (as per pilot study)	4 years
Proportion of persons referred for colectomy based on neoplastic findings	4 years
Mean time to next recommended surveillance examination	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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Biopsy; Inflammatory Bowel Disease; Colonoscopy; Dysplasia
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Inflammatory Bowel Diseases; Intestinal Diseases; Colonic Neoplasms
• Other Study ID Numbers: CTO1769

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No