A Randomized, Parallel-Group, Non-Inferiority Trial Comparing Random AND Targeted Biopsies to Targeted Biopsies Alone for Neoplasia Screening in Adult Persons With Colonic Inflammatory Bowel Diseases: A Pilot Study

Status: Completed
Location: See all (12) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To determine if random biopsies can be safely eliminated from screening of average risk persons with IBD, the investigators propose to carry out a pilot randomized control trial in which targeted biopsies in combination with random biopsies will be compared to targeted biopsies alone in terms of pre-cancerous lesion capture rate, side-effects and CRC risk. The pilot study will aim to capture 20% of the overall study population in order to evaluate the feasibility of recruiting the needed number of participants in the specified time frame, while maintaining high quality of data collection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 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

Locations
Other Locations
Canada
University of Alberta
Edmonton
Nova Scotia Health Authority
Halifax
Hamilton Health Sciences Corporation
Hamilton
London Health Sciences Centre, University Hospital
London
McGill University Health Centre
Montreal
Ottawa Hospital Research Institute
Ottawa
Eastern Regional Health Authority
St. John's
Thunder Bay Regional Health Sciences Centre
Thunder Bay
Mount Sinai Hospital
Toronto
St. Paul's Hospital
Vancouver
Pacific Digestive Health / Royal Jubilee Hospital
Victoria
University of Manitoba, Health Sciences Centre
Winnipeg
Time Frame
Start Date: 2020-11-06
Completion Date: 2022-10-06
Participants
Target number of participants: 600
Treatments
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.
Other: 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.
Sponsors
Collaborators: Health Sciences Centre, Winnipeg, Manitoba, McGill University Health Centre/Research Institute of the McGill University Health Centre, Thunder Bay Regional Health Sciences Centre, Providence Health & Services, Eastern Health, Hamilton Health Sciences Corporation, University of Alberta, University of Toronto, Western University, Canada, MOUNT SINAI HOSPITAL, Nova Scotia Health Authority, Royal Jubilee Hospital
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov