Interest of Artificial Intelligence in Cancer Screening Colonoscopy (IA COLO)

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Intestinal Polyps; Colonoscopy; Deep Learning
• Intervention / Treatment: Device: 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

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arthur BERGER; Phone Number: 05 57 65 64 39; Email: arthur.berger@chu-bordeaux.fr
• Study Contact Backup: Name: Camille DUCERF; Phone Number: 05 57 62 34 47; Email: camille.ducerf@chu-bordeaux.fr

Study Locations

• France
  • Angers, France, 49100
    • CHU d'Angers
  • Neuilly-sur-Seine, France, 92200
    • Hôpital Américain
  • Paris, France, 75015
    • Hopital Europeen Georges Pompidou
  • Paris, France, 75012
    • Hopital Saint Antoine
  • Talence, France, 33404
    • Centre Hospitalier Universitaire de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with indication for colonoscopy; 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.

Device: screening colonoscopy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of the sensitivity of the automatic characterization system CAD EYE.	Estimation of the sensitivity of the automatic characterization system CAD EYE for the diagnosis of the malignant character of colonic polyps. The sensitivity is calculated as the proportion of polyps detected by the CAD EYE characterization system among all the polyps that will be classified as malignant by the pathological analysis.The sensitivity estimate will be accompanied by its two-sided 95% confidence interval according to the exact binomial distribution. The estimated proportion will be compared with the theoretical value of 85% (minimum level from which this new technique is considered to be of interest) by a unilateral Chi2 test if the validity conditions are met or by an exact Fisher test, at 2.5% alpha threshold.	Inclusion date (date of the colonoscopy)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of the CAD EYE specificity	proportion of polyps not detected by the CAD EYE characterization system among all polyps that will be classified as benign by pathological analysis calculated, as with two-sided 95% confidence interval according to the exact binomial distribution	Inclusion date (date of the colonoscopy)
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.	the average number of polyps detected per patient with the CAD EYE system will be compared to that observed by the investigator performing the colorectal cancer screening colonoscopy using a Student's t test or Wilcoxon rank test according to the distribution of the judgment criterion.	Inclusion date (date of the colonoscopy)
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.	the reference test is the pathological examination of colonic polyps. The sensitivity of the CAD EYE system will be compared to that observed with the investigator performing the colonoscopy for colorectal cancer screening using a Chi2 test or Fisher's exact test (depending on the conditions of validity of the tests).	Inclusion date (date of the colonoscopy)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): January 25, 2023
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Colonoscopy; Colorectal Neoplasms; Deep Learning; Computer aided diagnosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Polyps; Intestinal Polyps
• Other Study ID Numbers: CHUBX 2020/46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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