Efficacy of CAD in Screening Colonoscopy to Reduce the Risk of Advanced Adenoma at 3 Years.

Last updated: March 13, 2026
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer Screening

Polyps

Treatment

Standard colonoscopy

Colonoscopy CADe

Clinical Study ID

NCT07299071
CHUBX 2024/48
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Patients over 18 years of age with indication for colonoscopy as part of a screeningprogram, after a positive immunological (FIT) test, and/or for personal or familyhistory of colorectal cancer and/or personal history of colonic adenomas,

  • Written informed consent signed

  • Patients covered by a health-care insurance.

Exclusion

Exclusion Criteria:

  • Failed complete colonoscopy, defined by the absence of cecal intubation and/or theabsence of terminal ileum cauterization

  • Inadequate bowel preparation (Boston bowel preparation score < 6, and/or least atone part of colon with score ≤ 1)

  • An infiltrative tumor was diagnosed during colonoscope insertion time, notaccessible to endoscopic resection and likely to require surgical management (aprocedure 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

Study Design

Total Participants: 592
Treatment Group(s): 2
Primary Treatment: Standard colonoscopy
Phase:
Study Start date:
March 13, 2026
Estimated Completion Date:
March 31, 2031

Study Description

Patients will be enrolled after a pre-colonoscopy consultation and risk-assessment for colorectal cancer. The screening colonoscopy will be performed by an investigator. Patients will be randomized in the endoscopy room after confirmed cecal intubation and quality of bowel preparation. Randomization into two groups: standard colonoscopy vs. colonoscopy with CADe (CAD EYE or GENIUS) (1:1). A follow-up consultation will be scheduled one-month postcolonoscopy for delivery of histological results and then at 3 years in order to organize the next colonoscopy. As part of the study, a new control colonoscopy will be scheduled for patients with high risk of CRC at 3 years. The 3-year control colonoscopy will be performed with the CAD system for all patients. The colonoscopy will be performed by another investigator who does not know the results nor the type of the first colonoscopy (evaluator blinded). In the low-risk group, we will collect follow-up data as part of routine care, including the results of colonoscopies performed outside of the protocol

Connect with a study center

  • CH de la Côte Basque

    Bayonne, 64100
    France

    Site Not Available

  • CH de la Côte Basque

    Bayonne 3034475, 64100
    France

    Site Not Available

  • CHU Brest la Cavale Blanche

    Brest, 29200
    France

    Site Not Available

  • CHU Brest la Cavale Blanche

    Brest 3030300, 29200
    France

    Site Not Available

  • Clinique Paris Bercy

    Charenton-le-Pont, 94220
    France

    Site Not Available

  • Clinique Paris Bercy

    Charenton-le-Pont 3026637, 94220
    France

    Site Not Available

  • CHU de Limoges

    Limoges, 87042
    France

    Site Not Available

  • CHU de Limoges

    Limoges 2998286, 87042
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille, 13009
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille 2995469, 13009
    France

    Site Not Available

  • Clinique Jules Verne

    Nantes, 44300
    France

    Site Not Available

  • Clinique Jules Verne

    Nantes 2990969, 44300
    France

    Site Not Available

  • CHU Nîmes

    Nîmes, 30029
    France

    Site Not Available

  • CHU Nîmes

    Nîmes 2990363, 30029
    France

    Site Not Available

  • APHP - Hôpital Saint Antoine

    Paris, 75012
    France

    Site Not Available

  • Aphp-Hegp

    Paris, 75015
    France

    Site Not Available

  • APHP - Hôpital Saint Antoine

    Paris 2988507, 75012
    France

    Site Not Available

  • Aphp-Hegp

    Paris 2988507, 75015
    France

    Site Not Available

  • CHU Bordeaux - Hôpital Haut Lévêque

    Pessac, 33604
    France

    Active - Recruiting

  • CHU Bordeaux - Hôpital Haut Lévêque

    Pessac 2987805, 33604
    France

    Site Not Available

  • CHU de Rennes

    Rennes, 35000
    France

    Site Not Available

  • CHU de Rennes

    Rennes 2983990, 35000
    France

    Site Not Available

  • Clinique Pasteur

    Toulouse, 31076
    France

    Site Not Available

  • Clinique Pasteur

    Toulouse 2972315, 31076
    France

    Site Not Available

  • CHRU de Nancy - Hôpital Brabois Adultes

    Vandœuvre-lès-Nancy, 54511
    France

    Site Not Available

  • CHRU de Nancy - Hôpital Brabois Adultes

    Vandœuvre-lès-Nancy 2970797, 54511
    France

    Site Not Available

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