Comparing biopsy methods for colorectal cancer screening in IBD patients
A Randomized Controlled Non-Inferiority Trial Comparing Neoplasia Detection During Colonoscopy Screening With and Without Non-Targeted Biopsies in Adult Colonic Inflammatory Bowel Disease
This study is testing if a new way of taking biopsies during colonoscopies can find colorectal cancer as effectively as the standard method in patients with inflammatory bowel disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1952 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 11 sites (Edmonton, Alberta and 10 other locations) |
| Trial ID | NCT05809999 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a targeted biopsy strategy during high-definition white light colonoscopy in patients with inflammatory bowel disease (IBD) who are undergoing colorectal neoplasia screening. It will compare the detection rates of neoplasia when sampling only visible lesions versus the conventional method of sampling both visible lesions and normal-appearing mucosa. The study will involve approximately 1952 participants and is designed as a multicenter, parallel-group, non-inferiority randomized controlled trial. The primary outcome will focus on the neoplasia detection rate to determine if the targeted approach is as effective as the conventional method.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a history of inflammatory bowel disease and symptomatic remission who are undergoing colonoscopy for neoplasia screening.
Not a fit: Patients who have a history of colorectal cancer or have undergone significant bowel resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more efficient and less invasive approach to colorectal cancer screening in patients with IBD.
How similar studies have performed: Other studies have shown promising results with targeted biopsy approaches in similar patient populations, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edmonton, Alberta and 10 other locations
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
- St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)
- University of Manitoba, Health Sciences Centre — Winnipeg, Manitoba, Canada (Recruiting)
- Eastern Regional Health Authority — St. John's, Nfld, Canada (Recruiting)
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Recruiting)
- Hamilton Health Sciences — Hamilton, Ontario, Canada (Recruiting)
- London Health Sciences Centre, University Hospital — London, Ontario, Canada (Recruiting)
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (Recruiting)
- Thunder Bay Regional Health Sciences Centre — Thunder Bay, Ontario, Canada (Recruiting)
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
- McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Sanjay Murthy, MD
- Email: smurthy@toh.ca
- Phone: (613)737-8899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.