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.
1 other identifier
interventional
592
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2025
CompletedFirst Posted
Study publicly available on registry
December 23, 2025
CompletedStudy Start
First participant enrolled
March 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2031
March 16, 2026
March 1, 2026
5 years
December 9, 2025
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Number of adenoma
36 months
Estimation of the sensitivity of CADx
Day0, 36 months
Estimation of the specificity of CADx
DAY 0, 36 months
Cost of CADe and classical colonoscopy
Day 0, 36 months
Study Arms (2)
Standard colonoscopy
PLACEBO COMPARATORPatients 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
Colonoscopy with CADe
ACTIVE COMPARATORPatients 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)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
CH de la Côte Basque
Bayonne, 64100, France
CHU Brest la Cavale Blanche
Brest, 29200, France
Clinique Paris Bercy
Charenton-le-Pont, 94220, France
CHU de Limoges
Limoges, 87042, France
Institut Paoli Calmettes
Marseille, 13009, France
Clinique Jules Verne
Nantes, 44300, France
CHU Nîmes
Nîmes, 30029, France
APHP - Hôpital Saint Antoine
Paris, 75012, France
Aphp-Hegp
Paris, 75015, France
CHU Bordeaux - Hôpital Haut Lévêque
Pessac, 33604, France
CHU de Rennes
Rennes, 35000, France
Clinique Pasteur
Toulouse, 31076, France
CHRU de Nancy - Hôpital Brabois Adultes
Vandœuvre-lès-Nancy, 54511, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2025
First Posted
December 23, 2025
Study Start
March 13, 2026
Primary Completion (Estimated)
March 1, 2031
Study Completion (Estimated)
March 1, 2031
Last Updated
March 16, 2026
Record last verified: 2026-03