Computer-aided detection during screening colonoscopy to lower advanced adenoma risk at 3 years
Randomized Controlled Trial Evaluating the Efficacy of CAD in Screening Colonoscopy to Reduce the Risk of Advanced Adenoma at 3 Years.
NA · University Hospital, Bordeaux · NCT07299071
This trial tests whether using computer-aided detection (CADe) during screening colonoscopy can lower the chance of developing advanced polyps or interval colorectal cancer over three years in adults having screening after a positive FIT or with personal or family risk factors.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 592 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux (other) |
| Locations | 13 sites (Bayonne and 12 other locations) |
| Trial ID | NCT07299071 on ClinicalTrials.gov |
What this trial studies
Adults referred for screening colonoscopy are enrolled after a pre-colonoscopy consultation and risk assessment, then randomized after confirmed cecal intubation and adequate bowel preparation to either standard colonoscopy or colonoscopy with a CADe system (CAD EYE or GENIUS). Histology results are delivered about one month after the procedure and participants are scheduled for a follow-up visit at three years to organize the next colonoscopy. At the three-year control, all patients receive a colonoscopy performed with the CADe system by an evaluator who is blinded to the initial procedure arm. Low-risk participants will have routine follow-up data collected, including any colonoscopies performed outside the protocol.
Who should consider this trial
Good fit: Adults over 18 who are having screening colonoscopy (for example after a positive FIT, with personal or family history of colorectal cancer, or prior colonic adenomas), who can give informed consent, are covered by health insurance, and are fluent in French are ideal candidates.
Not a fit: Patients with incomplete colonoscopy or inadequate bowel preparation, infiltrative tumors not amenable to endoscopic resection, inflammatory bowel disease, pregnancy, legal guardianship, illiteracy or not fluent in French are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could reduce the number of missed adenomas and lower the rate of advanced polyps or interval colorectal cancers detected at three years.
How similar studies have performed: Prior trials have shown CADe systems improve adenoma detection rates during colonoscopy, but whether that improvement translates into fewer advanced adenomas or interval cancers at multi-year follow-up remains uncertain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 ≤ 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 * 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
Where this trial is running
Bayonne and 12 other locations
- CH de la Côte Basque — Bayonne, France (NOT_YET_RECRUITING)
- CHU Brest la Cavale Blanche — Brest, France (NOT_YET_RECRUITING)
- Clinique Paris Bercy — Charenton-le-Pont, France (NOT_YET_RECRUITING)
- CHU de Limoges — Limoges, France (NOT_YET_RECRUITING)
- Institut Paoli Calmettes — Marseille, France (NOT_YET_RECRUITING)
- Clinique Jules Verne — Nantes, France (NOT_YET_RECRUITING)
- CHU Nîmes — Nîmes, France (NOT_YET_RECRUITING)
- APHP - Hôpital Saint Antoine — Paris, France (NOT_YET_RECRUITING)
- Aphp-Hegp — Paris, France (NOT_YET_RECRUITING)
- CHU Bordeaux - Hôpital Haut Lévêque — Pessac, France (RECRUITING)
- CHU de Rennes — Rennes, France (NOT_YET_RECRUITING)
- Clinique Pasteur — Toulouse, France (NOT_YET_RECRUITING)
- CHRU de Nancy - Hôpital Brabois Adultes — Vandœuvre-lès-Nancy, France (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Arthur BERGER, MD
- Email: arthur.berger@chu-bordeaux.fr
- Phone: +335 57 67 49 31
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colonoscopy, Colorectal Neoplasms, Intestinal Polyps, colonoscopy, colorectal neoplasms, computer aided diagnosis