Inflammatory Bowel Diseases Clinical Trial
— IBDDysplasiaOfficial title:
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
Verified date | March 2023 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 600 |
Est. completion date | October 6, 2022 |
Est. primary completion date | September 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - = 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 cannot or are unwilling to provide informed consent - Persons with a history of colorectal cancer - Persons with prior subtotal or total colectomy (> 50% of colon removed) - Persons undergoing colonoscopy to follow-up on recently diagnosed neoplasia identified within the past year - Persons undergoing pancolonic 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) - Moderate-to-severe inflammation (Mayo 2-3) involving = 25% of colorectum or mild inflammation (Mayo 1) involving = 50% of colorectum |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Canada | Nova Scotia Health Authority | Halifax | Nova Scotia |
Canada | Hamilton Health Sciences Corporation | 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 | Pacific Digestive Health / Royal Jubilee Hospital | Victoria | British Columbia |
Canada | University of Manitoba, Health Sciences Centre | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute | Eastern Health, Hamilton Health Sciences Corporation, Health Sciences Centre, Winnipeg, Manitoba, McGill University Health Centre/Research Institute of the McGill University Health Centre, MOUNT SINAI HOSPITAL, Nova Scotia Health Authority, Providence Health & Services, Royal Jubilee Hospital, Thunder Bay Regional Health Sciences Centre, University of Alberta, University of Toronto, Western University, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Number of Participants Enrolled | Number of participants enrolled within one year from the overall total required. | 1 year | |
Primary | Rate of Protocol Adherence | Rate of protocol adherence of major protocol violations on a per-patient basis. | 1 year | |
Primary | Rate of overall neoplasia detection | Overall neoplasia detection rate for the definitive trial. | 1 year | |
Primary | Adverse Events occurrence | Occurrence of serious and minor post-procedural adverse events within 2 weeks of procedure. | 2 weeks | |
Secondary | Rate of Study Variables | 1 year | ||
Secondary | Rate of Missed 2-Week Post-Procedural Assessment for Complications | 2 weeks |
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