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ColonoscopyIA-COLO 2NCT07299071

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

A study testing Standard colonoscopy and Colonoscopy CADe in people with Colonoscopy and Colorectal Neoplasms, run by University Hospital, Bordeaux at 15 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Standard colonoscopy and Colonoscopy CADe
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
592 participants
Where
15 sitesFrance
Study dates
13 Mar 2026to Mar 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Personal history of inflammatory bowel disease
  • Personal history of genetic predisposition of CRC
  • Personal history of major colorectal surgery involving total or subtotal colectomy

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Arthur BERGER, MD contact

+335 57 67 49 31

arthur.berger@chu-bordeaux.fr

15 sites in 1 country

France15 sites, 15 recruiting

  • CH de la Côte Basque

    Bayonne, 64100

    Felix GOUTORBE, MD, +33 5.59.44.31.36, f.goutorbe@ch-cotebasque.fr

    Félix GOUTORBE, MD

    Not yet recruiting

  • CHU Brest la Cavale Blanche

    Brest, 29200

    Lucille QUENEHERVE, MD, +332.98.34.71.16, lucille.queneherve@chu-brest.fr

    Lucille QUENEHERVE, MD

    Not yet recruiting

  • Hôpital de Carhaix

    Carhaix-Plouguer, 29270

    Rubeshen Pillay ARNACHELUM, MD, rubeshen-pillay.arnachellum@chu-brest.fr

    Rubeshen Pillay ARNACHELUM

    Not yet recruiting

  • Clinique Paris Bercy

    Charenton-le-Pont, 94220

    David KARSENTI, MD, +331.43.96.78.34, karsenti.paris@gmail.com

    David KARSENTI, MD

    Not yet recruiting

  • CHU de Limoges

    Limoges, 87042

    Rémi COLLIN, MD, +335.55.05.55.55, remi.collin@chu-limoges.com

    Rémi COLLIN, MD

    Not yet recruiting

  • Institut Paoli Calmettes

    Marseille, 13009

    Jean-Philippe RATONE, MD, +334 91 22 35 68, ratonej@ipc.unicancer.fr

    Jean-Philippe RATONE, MD

    Not yet recruiting

  • Clinique Jules Verne

    Nantes, 44300

    Bertrand BRIEAU, MD, +332.51.17.34.00, bertrand.brieau@gmail.com

    Bertrand BRIEAU, MD

    Not yet recruiting

  • CHU Nîmes

    Nîmes, 30029

    Ludovic CAILLO, MD, +334.66.68.31.83, ludovic.caillo@chu-nimes.fr

    Ludovic CAILLO, MD

    Not yet recruiting

  • APHP - Hôpital Saint Antoine

    Paris, 75012

    Xavier DRAY, MD, +331.49.28.27.10, xavier.dray@aphp.fr

    Xavier DRAY, MD

    Not yet recruiting

  • Aphp-Hegp

    Paris, 75015

    Guillaume PERROD, MD, +331.56.09.57.00, guillaume.perrod@aphp.fr

    Guillaume PERROD, MD

    Not yet recruiting

  • APHP - Hôpital Tenon

    Paris, 75020

    Antoine GUILLOUX, MD, +331.56.01.63.16, antoine.guilloux@aphp.fr

    Antoine GUILLOUX, MD

    Not yet recruiting

  • CHU Bordeaux - Hôpital Haut Lévêque

    Pessac, 33604

    Arthur BERGER, MD, +335 57 67 49 31, arthur.berger@chu-bordeaux.fr

    Arthur BERGER, MD

    Recruiting

  • CHU de Rennes

    Rennes, 35000

    Timothée WALLENHORST, MD, +332.99.28.43.21, timothee.wallenhorst@chu-rennes.fr

    Timothée WALLENHORST, MD

    Not yet recruiting

  • Clinique Pasteur

    Toulouse, 31076

    Mathieu GUIVARCH, MD, +331.49.28.27.10, mguivarch@clinique-pasteur.com

    Mathieu GUIVARCH, MD

    Not yet recruiting

  • CHRU de Nancy - Hôpital Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

    Marion SCHAEFER, MD, +333.83.15.41.49, m.schaefer@chru-nancy.fr

    Marion SCHAEFER, MD

    Not yet recruiting

Other trials in France

About this study

Official title: 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.

Read the 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

Being tested
Standard colonoscopy, Colonoscopy CADe
Keywords
colonoscopy, colorectal neoplasms, computer aided diagnosis
Medical subject headings
Colorectal Neoplasms, Intestinal Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard colonoscopyProcedure or surgery

    Colonoscopy standard (without CADe)

  • Colonoscopy CADeProcedure or surgery

    colonoscopy with CADe

Study groups in NCT07299071
Study groupRoleWhat they receive
Standard colonoscopyPlacebo 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
Receives: Procedure: Standard colonoscopy
Colonoscopy with CADeActive 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)
Receives: Procedure: Colonoscopy CADe

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 36 months

Secondary outcomes (4)

  1. 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

    Measured: 36 months

  2. 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.

    Measured: Day0, 36 months

  3. 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.

    Measured: DAY 0, 36 months

  4. Cost of CADe and classical colonoscopy

    The cost of CADe and classical colonoscopy will be estimated using a bottom-up micro costing approach

    Measured: Day 0, 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2025
  2. Study start13 Mar 2026
  3. Primary completionMar 2031 (estimated)
  4. Study completionMar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
592 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07299071
Sponsor's protocol ID
CHUBX 2024/48
Acronym
IA-COLO 2
Status last verified
Mar 2026
First submitted
9 Dec 2025
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Standard colonoscopy and Colonoscopy CADe in people with Colonoscopy and Colorectal Neoplasms, run by University Hospital, Bordeaux at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arthur BERGER, MD (+335 57 67 49 31, arthur.berger@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Advanced adenoma (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07299071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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