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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
1,952
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.
University of Alberta
Edmonton, Alberta, Canada
RECRUITINGSt. Paul's Hospital
Vancouver, British Columbia, Canada
RECRUITINGProportion of persons with ≥ 1 neoplastic lesion detected
Time frame: 4 years
Mean number of neoplastic lesions per person
Time frame: 4 years
Proportion of persons with ≥ 1 high grade dysplastic lesion or colorectal cancers detected
Time frame: 4 years
Mean # high grade dysplastic lesions or colorectal cancers per person
Time frame: 4 years
Mean # tissue samples per person
Time frame: 4 years
Mean procedure time
Time frame: 4 years
Rate of major adverse events within 2 weeks of procedure (as per pilot study)
Time frame: 4 years
Proportion of persons referred for colectomy based on neoplastic findings
Time frame: 4 years
Mean time to next recommended surveillance examination
Time frame: 4 years
CRC incidence over five years following study colonoscopy (obtained through patient linkage to provincial cancer registries five years following trial completion)
Time frame: 4 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Manitoba, Health Sciences Centre
Winnipeg, Manitoba, Canada
RECRUITINGEastern Regional Health Authority
St. John's, NFLD, Canada
RECRUITINGNova Scotia Health Authority
Halifax, Nova Scotia, Canada
RECRUITINGHamilton Health Sciences
Hamilton, Ontario, Canada
RECRUITINGLondon Health Sciences Centre, University Hospital
London, Ontario, Canada
RECRUITINGOttawa Hospital Research Institute
Ottawa, Ontario, Canada
RECRUITINGThunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
RECRUITINGMount Sinai Hospital
Toronto, Ontario, Canada
RECRUITING...and 1 more locations