Clinical trial NCT04921488: Interest of Artificial Intelligence in Cancer Screening Colonoscopy
Official title: Cross-sectional, Multi-center Study Comparing Diagnostic Performance Between the CAD EYE System and the Physician on Histological Prediction of Colonic Polyps in Screening of Colorectal Cancer by Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Colorectal Neoplasms
Intestinal Polyps
Deep Learning
Keywords: Colonoscopy
Colorectal Neoplasms
Computer aided diagnosis
Deep Learning
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with indication for colonoscopy as part of a screening colonoscopy.
Primary purpose: DIAGNOSTIC

Brief summary: Artificial Intelligence (AI) to predict the histology of polyps per colonoscopy, offers a promising solution to reduce variation in colonoscopy performance. This new and innovative non-invasive technology will improve the quality of screening colonoscopies, and reduce the costs of colorectal cancer screening. The aim of the study is to performed a cross-sectional, multi-center study evaluating the diagnostic performance of the CAD EYE automatic characterization system for the histology of colonic polyps in colorectal cancer screening colonoscopy.

Detailed description: Deep learning to predict the histology of polyps per colonoscopy, offers a promising solution to reduce variation in colonoscopy performance. Meanwhile, the concept of 'optical biopsy' where in vivo classification of polyps based on enhanced imaging replaces histopathology has not been incorporated into routine practice, largely limited by inter-observer variability and generally meeting accepted standards only in expert settings. Real-time decision support software has been developed to detect and characterise polyps, whilst also offering feedback on the technical quality of inspection.

This study will evaluate the performance of the CAD EYE automatic characterization system for the histology compared to histological analysis. And secondary aims : the diagnostic performance of the CAD EYE automated detection device compared to a standardized video recording with blind independent review.

Procedure: The screening colonoscopy will be performed by an investigator. The automatic detection and characterization system will be activated at the time of descent of the colonoscopy (after caecal intubation), with video recording (image without CAD EYE and image with CAD EYE). The investigator performing the colonoscopy will be blinded by the results of the CAD EYE.

Follow-up: no specific follow-up is planned after colposcopy

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age with indication for colonoscopy as part of a screening colonoscopy, after a positive immunological test, and/or for personal or family history of colon cancer (before 60 years), personal history of colonic adenoma.
* Patient with at least one polyp detected, resect and removed during colonoscopy, for histological analysis

Exclusion Criteria:

* Guardianship or protection,
* pregnancy,
* not fluent in French or illiterate,
* lack of health care

Primary outcomes:
measure: Estimation of the sensitivity of the automatic characterization system CAD EYE.
timeFrame: Inclusion date (date of the colonoscopy)
Secondary outcomes:
measure: Estimation of the CAD EYE specificity
timeFrame: Inclusion date (date of the colonoscopy)
measure: Comparison of the average number of polyps detected per patient between a colonoscopy assisted by the CAD EYE system and a colonoscopy performed without this assistance.
timeFrame: Inclusion date (date of the colonoscopy)
measure: Compare the diagnostic performance to determine the malignancy of polyps between the automated colonic polyp detection device by the CAD EYE system, and the investigator performing the colonoscopy for colorectal cancer screening.
timeFrame: Inclusion date (date of the colonoscopy)
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Neuilly-sur-Seine
country: France
facility: Hopital Américain
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Talence
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
Study officials:
References: