Interest of Artificial Intelligence in Cancer Screening Colonoscopy

NCT04921488 | Completed

• 1 other identifier: CHUBX 2020/46
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 5

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.

Conditions

Colonoscopy; Colorectal Neoplasms; Intestinal Polyps; Deep Learning

Keywords

Colonoscopy; Colorectal Neoplasms; Computer aided diagnosis; Deep Learning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Estimation of the CAD EYE specificity

  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.

  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.

  Inclusion date (date of the colonoscopy)

Study Arms (1)

Patients with indication for colonoscopy

EXPERIMENTAL

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

Interventions

screening colonoscopy DEVICE

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.

Patients with indication for colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (5)

CHU d'Angers

Angers, 49100, France

Location

Hopital Américain

Neuilly-sur-Seine, 92200, France

Location

Hôpital Saint Antoine

Paris, 75012, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Centre Hospitalier Universitaire de Bordeaux

Talence, 33404, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Intestinal Polyps

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with indication for colonoscopy as part of a screening colonoscopy.

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: October 21, 2021
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)