IBD Neoplasia Surveillance RCT

Inflammatory Bowel Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05809999
• Other study ID #: CTO1769
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: April 2024
• Source: Ottawa Hospital Research Institute
• Contact: Sanjay Murthy, MD
• Phone: (613)737-8899
• Email: smurthy[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1952
• Est. completion date: February 28, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Dysplasia
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	London Health Sciences Centre, University Hospital	London	Ontario
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	Eastern Regional Health Authority	St. John's	NFLD
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	University of Manitoba, Health Sciences Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

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