Clinical trial NCT05809999: IBD Neoplasia Surveillance RCT
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colonic Neoplasms
Inflammatory Bowel Diseases
Dysplasia
Keywords: Inflammatory Bowel Disease
Dysplasia
Biopsy
Colonoscopy
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 1952
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Proportion of persons with ≥ 1 neoplastic lesion detected
timeFrame: 4 years
Secondary outcomes:
measure: Mean number of neoplastic lesions per person
timeFrame: 4 years
measure: Proportion of persons with ≥ 1 high grade dysplastic lesion or colorectal cancers detected
timeFrame: 4 years
measure: Mean # high grade dysplastic lesions or colorectal cancers per person
timeFrame: 4 years
measure: Mean # tissue samples per person
timeFrame: 4 years
measure: Mean procedure time
timeFrame: 4 years
measure: Rate of major adverse events within 2 weeks of procedure (as per pilot study)
timeFrame: 4 years
measure: Proportion of persons referred for colectomy based on neoplastic findings
timeFrame: 4 years
measure: Mean time to next recommended surveillance examination
timeFrame: 4 years
measure: CRC incidence over five years following study colonoscopy (obtained through patient linkage to provincial cancer registries five years following trial completion)
timeFrame: 4 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba, Health Sciences Centre
state: Manitoba
city: St. John's
country: Canada
facility: Eastern Regional Health Authority
state: NFLD
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
References: