Computer-aided detection during screening colonoscopy to lower advanced adenoma risk at 3 years

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 and/or sessile serrated polyp,
* Written informed consent signed
* Patients covered by a health-care insurance.

Exclusion Criteria:

* 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
* Pregnant women
* Not fluent in French or illiterate
* Personal history of inflammatory bowel disease
* Personal history of genetic predisposition of CRC
* Personal history of major colorectal surgery involving total or subtotal colectomy

Where it's running

• CHU Bordeaux - Hôpital Haut Lévêque
  Pessac, France Recruiting
• CH de la Côte Basque
  Bayonne, France Not yet recruiting
• CHU Brest la Cavale Blanche
  Brest, France Not yet recruiting
• Hôpital de Carhaix
  Carhaix-Plouguer, France Not yet recruiting
• Clinique Paris Bercy
  Charenton-le-Pont, France Not yet recruiting
• CHU de Limoges
  Limoges, France Not yet recruiting

Study contacts

• Study coordinator: Arthur BERGER, MD
• Email: arthur.berger@chu-bordeaux.fr
• Phone: +335 57 67 49 31

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.