Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
1952 participants
INTERVENTIONAL
2022-09-23
2026-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
IBD Neoplasia Surveillance Pilot RCT
NCT04067778
Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease
NCT01819766
Computerized Tomographic Colonography Compared With Standard Diagnostic Procedures in Detecting Colorectal Neoplasia
NCT00005809
Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
NCT02503696
Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of CRC
NCT05530746
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Standard colonoscopy with targeted biopsies
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.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard colonoscopy with targeted biopsies
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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 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
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ottawa Hospital Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alberta
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
University of Manitoba, Health Sciences Centre
Winnipeg, Manitoba, Canada
Eastern Regional Health Authority
St. John's, NFLD, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
London Health Sciences Centre, University Hospital
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTO1769
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.