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

NCT ID: NCT07299071

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

592 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2031-03-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Colonoscopy Colorectal Neoplasms Intestinal Polyps

Keywords

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colonoscopy colorectal neoplasms computer aided diagnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Standard colonoscopy

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. Patient has standard colonoscopy

Group Type PLACEBO_COMPARATOR

Standard colonoscopy

Intervention Type PROCEDURE

Colonoscopy standard (without CADe)

Colonoscopy with CADe

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. Patient has colonoscopy with CADe (CAD EYE or GENIUS)

Group Type ACTIVE_COMPARATOR

Colonoscopy CADe

Intervention Type PROCEDURE

colonoscopy with CADe

Interventions

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Standard colonoscopy

Colonoscopy standard (without CADe)

Intervention Type PROCEDURE

Colonoscopy CADe

colonoscopy with CADe

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CH de la Côte Basque

Bayonne, , France

Site Status

CHU Brest la Cavale Blanche

Brest, , France

Site Status

Clinique Paris Bercy

Charenton-le-Pont, , France

Site Status

CHU de Limoges

Limoges, , France

Site Status

Institut Paoli Calmettes

Marseille, , France

Site Status

Clinique Jules Verne

Nantes, , France

Site Status

CHU Nîmes

Nîmes, , France

Site Status

APHP - Hôpital Saint Antoine

Paris, , France

Site Status

Aphp-Hegp

Paris, , France

Site Status

CHU Bordeaux - Hôpital Haut Lévêque

Pessac, , France

Site Status

CHU de Rennes

Rennes, , France

Site Status

Clinique Pasteur

Toulouse, , France

Site Status

CHRU de Nancy - Hôpital Brabois Adultes

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Central Contacts

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Arthur BERGER, MD

Role: CONTACT

Phone: +335 57 67 49 31

Email: [email protected]

Facility Contacts

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Felix GOUTORBE, MD

Role: primary

Lucille QUENEHERVE, MD

Role: primary

David KARSENTI, MD

Role: primary

Rémi COLLIN, MD

Role: primary

Jean-Philippe RATONE, MD

Role: primary

Bertrand BRIEAU, MD

Role: primary

Ludovic CAILLO, MD

Role: primary

Xavier DRAY, MD

Role: primary

Guillaume PERROD, MD

Role: primary

Arthur BERGER, MD

Role: primary

Timothée WALLENHORST, MD

Role: primary

Mathieu GUIVARCH, MD

Role: primary

Marion SCHAEFER, MD

Role: primary

Other Identifiers

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CHUBX 2024/48

Identifier Type: -

Identifier Source: org_study_id