Efficacy of CAD in Screening Colonoscopy to Reduce the Risk of Advanced Adenoma at 3 Years. (IA-COLO 2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Neoplasms; Intestinal Polyps; Colonoscopy
• Intervention / Treatment: Procedure: Standard colonoscopy; Procedure: Colonoscopy CADe

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 592
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• France
  • Bayonne, France, 64100
    • Not yet recruiting
    • CH de la Côte Basque
    • Contact: Felix GOUTORBE, MD; Phone Number: +33 5.59.44.31.36; Email: f.goutorbe@ch-cotebasque.fr
    • Principal Investigator: Félix GOUTORBE, MD
  • Brest, France, 29200
    • Not yet recruiting
    • CHU Brest la Cavale Blanche
    • Contact: Lucille QUENEHERVE, MD; Phone Number: +332.98.34.71.16; Email: lucille.queneherve@chu-brest.fr
    • Principal Investigator: Lucille QUENEHERVE, MD
  • Charenton-le-Pont, France, 94220
    • Not yet recruiting
    • Clinique Paris Bercy
    • Contact: David KARSENTI, MD; Phone Number: +331.43.96.78.34; Email: karsenti.paris@gmail.com
    • Principal Investigator: David KARSENTI, MD
  • Limoges, France, 87042
    • Not yet recruiting
    • CHU de Limoges
    • Contact: Rémi COLLIN, MD; Phone Number: +335.55.05.55.55; Email: remi.collin@chu-limoges.com
    • Principal Investigator: Rémi COLLIN, MD
  • Marseille, France, 13009
    • Not yet recruiting
    • Institut Paoli Calmettes
    • Principal Investigator: Jean-Philippe RATONE, MD
    • Contact: Jean-Philippe RATONE, MD; Phone Number: +334 91 22 35 68; Email: ratonej@ipc.unicancer.fr
  • Nantes, France, 44300
    • Not yet recruiting
    • Clinique Jules Verne
    • Contact: Bertrand BRIEAU, MD; Phone Number: +332.51.17.34.00; Email: bertrand.brieau@gmail.com
    • Principal Investigator: Bertrand BRIEAU, MD
  • Nîmes, France, 30029
    • Not yet recruiting
    • CHU Nîmes
    • Principal Investigator: Ludovic CAILLO, MD
    • Contact: Ludovic CAILLO, MD; Phone Number: +334.66.68.31.83; Email: ludovic.caillo@chu-nimes.fr
  • Paris, France, 75015
    • Not yet recruiting
    • Aphp-Hegp
    • Contact: Guillaume PERROD, MD; Phone Number: +331.56.09.57.00; Email: guillaume.perrod@aphp.fr
    • Principal Investigator: Guillaume PERROD, MD
  • Paris, France, 75012
    • Not yet recruiting
    • APHP - Hôpital Saint Antoine
    • Contact: Xavier DRAY, MD; Phone Number: +331.49.28.27.10; Email: xavier.dray@aphp.fr
    • Principal Investigator: Xavier DRAY, MD
  • Pessac, France, 33604
    • Recruiting
    • Chu Bordeaux - Hôpital Haut Lévêque
    • Principal Investigator: Arthur BERGER, MD
    • Contact: Arthur BERGER, MD; Phone Number: +335 57 67 49 31; Email: arthur.berger@chu-bordeaux.fr
  • Rennes, France, 35000
    • Not yet recruiting
    • CHU de Rennes
    • Principal Investigator: Timothée WALLENHORST, MD
    • Contact: Timothée WALLENHORST, MD; Phone Number: +332.99.28.43.21; Email: timothee.wallenhorst@chu-rennes.fr
  • Toulouse, France, 31076
    • Not yet recruiting
    • Clinique Pasteur
    • Contact: Mathieu GUIVARCH, MD; Phone Number: +331.49.28.27.10; Email: mguivarch@clinique-pasteur.com
    • Principal Investigator: Mathieu GUIVARCH, MD
  • Vandœuvre-lès-Nancy, France, 54511
    • Not yet recruiting
    • CHRU de Nancy - Hôpital Brabois Adultes
    • Principal Investigator: Marion SCHAEFER, MD
    • Contact: Marion SCHAEFER, MD; Phone Number: +333.83.15.41.49; Email: m.schaefer@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Procedure: Standard colonoscopy; Colonoscopy standard (without CADe)
Active Comparator: 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)	Procedure: Colonoscopy CADe; colonoscopy with CADe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Advanced adenoma	The proportion of patients presenting at least one advanced adenoma detected after a 3-year follow-up period. An advanced adenoma is defined as an adenoma or sessile serrate adenoma (SSL) larger than 1cm (size confirmed by the CAD system and/or size estimation by snare), and/or with high-grade dysplasia or neoplasia (confirmed by histological analysis).	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adenoma	Average number of adenoma or SSL (confirmed by histological analysis) detected in each patient during screening colonoscopy after a 3-year follow-up period	36 months
Estimation of the sensitivity of CADx	Estimated sensitivity of CADx (CAD for characterization is named CADx) for the diagnosis and evaluation of colonic polyp's malignancy, with histologic analysis in each center as a reference diagnosis.	Day0, 36 months
Estimation of the specificity of CADx	Estimated specificity of CADx (CAD for characterization is named CADx) for the diagnosis and evaluation of colonic polyp's malignancy, with histologic analysis in each center as a reference diagnosis.	DAY 0, 36 months
Cost of CADe and classical colonoscopy	The cost of CADe and classical colonoscopy will be estimated using a bottom-up micro costing approach	Day 0, 36 months

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: colonoscopy; colorectal neoplasms; computer aided diagnosis
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Polyps; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Polyps
• Other Study ID Numbers: CHUBX 2024/48

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No