Actively Recruiting
Randomized Controlled Trial Evaluating the Efficacy of CAD in Screening Colonoscopy to Reduce the Risk of Advanced Adenoma at 3 Years
Led by University Hospital, Bordeaux · Updated on 2026-03-16
592
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of computer-aided diagnosis (CAD) systems during colonoscopy to detect colorectal lesions and potentially reduce the risk of advanced adenomas or interval cancers over three years. The study addresses the challenge of missed lesions during colonoscopy and evaluates whether CAD can improve cancer prevention in patients undergoing colorectal cancer screening. Participants will be randomly assigned during their screening colonoscopy to receive either a standard colonoscopy or a colonoscopy assisted by a CAD system (CAD EYE or GENIUS). After the initial procedure, patients will have a follow-up consultation one month later and then a scheduled colonoscopy at three years. For those at higher risk, the three-year follow-up colonoscopy will use the CAD system again, performed by a different investigator who is unaware of previous results. During the study, researchers will monitor outcomes such as the presence of advanced adenomas at 36 months, the number of adenomas detected, and the sensitivity and specificity of the CAD system. They will also evaluate the costs associated with CAD versus standard colonoscopy. Data from routine care colonoscopies will be collected for low-risk patients. The total participation duration extends to at least three years, including follow-up visits and repeat colonoscopies as scheduled.
CONDITIONS
Brief Title
Efficacy of CAD in Screening Colonoscopy to Reduce the Risk of Advanced Adenoma at 3 Years.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Written informed consent signed
- Patients covered by a health-care insurance
You will not qualify if you...
- Failed complete colonoscopy, defined by the absence of cecal intubation and/or the absence of terminal ileum cauterization
- Inadequate bowel preparation (Boston bowel preparation score < 6, and/or least at one part of colon with score 41)
- An infiltrative tumor was diagnosed during colonoscope insertion time, not accessible to endoscopic resection and likely to require surgical management
- Patient under guardianship or protection
- Pregnant women
- Not fluent in French or illiterate
- Personal history of inflammatory bowel disease
- Personal history of genetic predisposition of CRC
- Personal history of colonic surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 pre-colonoscopy consultation visit
Duration - Day 0
Participants undergo a screening colonoscopy and are randomized to receive either standard colonoscopy or colonoscopy with CADe.
1 colonoscopy visit (in-person, randomized after confirmed cecal intubation and bowel preparation)
Duration - 1 month
Participants have a follow-up consultation one month after colonoscopy to receive histological results.
1 follow-up consultation visit
Duration - 3 years
Participants are monitored over 3 years, including a new control colonoscopy for high-risk patients and routine care follow-up for low-risk patients.
1 control colonoscopy visit for high-risk patients and routine follow-up for low-risk patients
Trial Site Locations
Total: 13 locations
1
CH de la Côte Basque
Bayonne, France, 64100
Not Yet Recruiting
2
CHU Brest la Cavale Blanche
Brest, France, 29200
Not Yet Recruiting
3
Clinique Paris Bercy
Charenton-le-Pont, France, 94220
Not Yet Recruiting
4
CHU de Limoges
Limoges, France, 87042
Not Yet Recruiting
5
Institut Paoli Calmettes
Marseille, France, 13009
Not Yet Recruiting
6
Clinique Jules Verne
Nantes, France, 44300
Not Yet Recruiting
7
CHU Nîmes
Nîmes, France, 30029
Not Yet Recruiting
8
APHP - Hôpital Saint Antoine
Paris, France, 75012
Not Yet Recruiting
9
Aphp-Hegp
Paris, France, 75015
Not Yet Recruiting
10
CHU Bordeaux - Hôpital Haut Lévêque
Pessac, France, 33604
Actively Recruiting
11
CHU de Rennes
Rennes, France, 35000
Not Yet Recruiting
12
Clinique Pasteur
Toulouse, France, 31076
Not Yet Recruiting
13
CHRU de Nancy - Hôpital Brabois Adultes
Vandœuvre-lès-Nancy, France, 54511
Not Yet Recruiting
Research Team
A
Arthur BERGER, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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