IBD Neoplasia Surveillance Pilot RCT
IBDDysplasia
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
1 other identifier
interventional
600
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
Typical duration for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2019
CompletedFirst Posted
Study publicly available on registry
August 26, 2019
CompletedStudy Start
First participant enrolled
November 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2022
CompletedMarch 31, 2023
March 1, 2023
1.9 years
August 7, 2019
March 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Overall Number of Participants Enrolled
Number of participants enrolled within one year from the overall total required.
1 year
Rate of Protocol Adherence
Rate of protocol adherence of major protocol violations on a per-patient basis.
1 year
Rate of overall neoplasia detection
Overall neoplasia detection rate for the definitive trial.
1 year
Adverse Events occurrence
Occurrence of serious and minor post-procedural adverse events within 2 weeks of procedure.
2 weeks
Secondary Outcomes (2)
Rate of Study Variables
1 year
Rate of Missed 2-Week Post-Procedural Assessment for Complications
2 weeks
Study Arms (2)
Intervention Group
EXPERIMENTALParticipants 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.
Control Group
OTHERParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ottawa Hospital Research Institutelead
- Health Sciences Centre, Winnipeg, Manitobacollaborator
- Western University, Canadacollaborator
- University of Torontocollaborator
- Hamilton Health Sciences Corporationcollaborator
- Thunder Bay Regional Health Sciences Centrecollaborator
- Eastern Healthcollaborator
- McGill University Health Centre/Research Institute of the McGill University Health Centrecollaborator
- Providence Health & Servicescollaborator
- Royal Jubilee Hospitalcollaborator
- University of Albertacollaborator
- MOUNT SINAI HOSPITALcollaborator
- Nova Scotia Health Authoritycollaborator
Study Sites (12)
University of Alberta
Edmonton, Alberta, 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, Canada
Eastern Regional Health Authority
St. John's, NFLD, A1B 3V6, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8L 8E7, Canada
London Health Sciences Centre, University Hospital
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Related Publications (1)
Murthy SK, Marderfeld L, Fergusson D, Ramsay T, Bernstein CN, Nguyen GC, Jairath V, Riddell R. A randomized trial evaluating the utility of non-targeted biopsies for colorectal neoplasia detection in adults with inflammatory bowel disease: a pilot study protocol. Pilot Feasibility Stud. 2024 Feb 1;10(1):20. doi: 10.1186/s40814-023-01434-8.
PMID: 38297397DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2019
First Posted
August 26, 2019
Study Start
November 6, 2020
Primary Completion
September 20, 2022
Study Completion
October 6, 2022
Last Updated
March 31, 2023
Record last verified: 2023-03