Trial Title:
IBD Neoplasia Surveillance RCT
NCT ID:
NCT05809999
Condition:
Colonic Neoplasms
Inflammatory Bowel Diseases
Dysplasia
Conditions: Official terms:
Colonic Neoplasms
Intestinal Diseases
Inflammatory Bowel Diseases
Conditions: Keywords:
Inflammatory Bowel Disease
Dysplasia
Biopsy
Colonoscopy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Standard colonoscopy with targeted biopsies
Description:
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.
Arm group label:
Experimental: Intervention Group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alberta
Address:
City:
Edmonton
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Frank Hoentjen
Email:
Principal Investigator
Facility:
Name:
St. Paul's Hospital
Address:
City:
Vancouver
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Brian Bressler
Email:
Principal Investigator
Facility:
Name:
University of Manitoba, Health Sciences Centre
Address:
City:
Winnipeg
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Charles Bernstein
Email:
Principal Investigator
Facility:
Name:
Eastern Regional Health Authority
Address:
City:
St. John's
Zip:
A1B 3V6
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Mark Borgaonkar
Email:
Principal Investigator
Facility:
Name:
Nova Scotia Health Authority
Address:
City:
Halifax
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Jennifer Jones
Email:
Principal Investigator
Facility:
Name:
Hamilton Health Sciences
Address:
City:
Hamilton
Zip:
L8L 8E7
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Jane Castelli
Phone:
289-880-3609
Email:
jcast@mcmaster.ca
Investigator:
Last name:
Neeraj Narula, MD
Email:
Principal Investigator
Facility:
Name:
London Health Sciences Centre, University Hospital
Address:
City:
London
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Vipul Jairath
Email:
Principal Investigator
Facility:
Name:
Ottawa Hospital Research Institute
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Sanjay Murthy
Email:
Principal Investigator
Facility:
Name:
Thunder Bay Regional Health Sciences Centre
Address:
City:
Thunder Bay
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Petros Zezos
Email:
Principal Investigator
Facility:
Name:
Mount Sinai Hospital
Address:
City:
Toronto
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Geoff Nguyen
Email:
Principal Investigator
Facility:
Name:
McGill University Health Centre
Address:
City:
Montreal
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Talat Bessissow
Email:
Principal Investigator
Start date:
September 23, 2022
Completion date:
February 28, 2026
Lead sponsor:
Agency:
Ottawa Hospital Research Institute
Agency class:
Other
Source:
Ottawa Hospital Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05809999
