Efficacy of CAD in Screening Colonoscopy to Reduce the Risk of Advanced Adenoma at 3 Years.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux
About this trial
The occurrence of interval cancers after colonoscopy raises the possibility of missed lesions. High- performance computer aided diagnosis (CAD) systems have been specially designed for the detection of colorectal lesions (CAD for detection is named CADe). The use of CADe improves adenoma detection in screening colonoscopy. The potential of CADe system in reducing the rate of progression to advanced polyps or interval cancer between two colonoscopies remains still uncertain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 18 years of age with indication for colonoscopy as part of a screening program, after a positive immunological (FIT) test, and/or for personal or family history of colorectal cancer and/or personal history of colonic adenomas and/or sessile serrated polyp,
Written informed consent signed
Patients covered by a health-care insurance.
Disqualifiers
Failed complete colonoscopy, defined by the absence of cecal intubation or identification of the terminal ileum.
Inadequate bowel preparation (Boston bowel preparation score < 6, and/or least at one part of colon with score ≤ 1)
An infiltrative tumor was diagnosed during colonoscope insertion time, not accessible to endoscopic resection and likely to require surgical management (a procedure where part of the colon may need to be removed).
Patient under guardianship or protection
Trial design
Design model
Parallel
Treatments tested in this trial
Standard colonoscopy
Procedure/SurgeryColonoscopy standard (without CADe)
Colonoscopy CADe
Procedure/Surgerycolonoscopy with CADe
Treatment groups
592 Participants
are divided into 2 treatment groupsGroup A: Standard colonoscopyPlacebo comparator 1 intervention
Group B: Colonoscopy with CADeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Advanced adenoma
The proportion of patients presenting at least one advanced adenoma detected after a 3-year follow-up period. An advanced adenoma is defined as an adenoma or sessile serrate adenoma (SSL) larger than 1cm (size confirmed by the CAD system and/or size estimation by snare), and/or with high-grade dysplasia or neoplasia (confirmed by histological analysis).
Time frame
36 monthsSecondary outcomes
1
Number of adenoma
Average number of adenoma or SSL (confirmed by histological analysis) detected in each patient during screening colonoscopy after a 3-year follow-up period
Time frame
36 months2
Estimation of the sensitivity of CADx
Estimated sensitivity of CADx (CAD for characterization is named CADx) for the diagnosis and evaluation of colonic polyp's malignancy, with histologic analysis in each center as a reference diagnosis.
Time frame
Day0, 36 months3
Estimation of the specificity of CADx
Estimated specificity of CADx (CAD for characterization is named CADx) for the diagnosis and evaluation of colonic polyp's malignancy, with histologic analysis in each center as a reference diagnosis.
Time frame
DAY 0, 36 months4
Cost of CADe and classical colonoscopy
The cost of CADe and classical colonoscopy will be estimated using a bottom-up micro costing approach
Time frame
Day 0, 36 monthsSponsors and contacts
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Source ClinicalTrials.gov