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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard colonoscopy | Placebo Comparator | 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 |
|
| Colonoscopy with CADe | Active Comparator | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard colonoscopy | Procedure | Colonoscopy standard (without CADe) |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arthur BERGER, MD | Contact | +335 57 67 49 31 | arthur.berger@chu-bordeaux.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH de la Côte Basque | Not yet recruiting | Bayonne | 64100 | France |
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| Colonoscopy CADe |
| Procedure |
colonoscopy with CADe |
|
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 |
| CHU Brest la Cavale Blanche | Not yet recruiting | Brest | 29200 | France |
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| Clinique Paris Bercy | Not yet recruiting | Charenton-le-Pont | 94220 | France |
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| CHU de Limoges | Not yet recruiting | Limoges | 87042 | France |
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| Institut Paoli Calmettes | Not yet recruiting | Marseille | 13009 | France |
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| Clinique Jules Verne | Not yet recruiting | Nantes | 44300 | France |
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| CHU Nîmes | Not yet recruiting | Nîmes | 30029 | France |
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| APHP - Hôpital Saint Antoine | Not yet recruiting | Paris | 75012 | France |
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| Aphp-Hegp | Not yet recruiting | Paris | 75015 | France |
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| CHU Bordeaux - Hôpital Haut Lévêque | Recruiting | Pessac | 33604 | France |
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| CHU de Rennes | Not yet recruiting | Rennes | 35000 | France |
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| Clinique Pasteur | Not yet recruiting | Toulouse | 31076 | France |
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| CHRU de Nancy - Hôpital Brabois Adultes | Not yet recruiting | Vandœuvre-lès-Nancy | 54511 | France |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007417 | Intestinal Polyps |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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