Evaluation of the Potential Impact of an Artificial Intelligence Solution in Second Reading of Organized Screening. (ELIAS)

June 27, 2024 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche

Based on data from a series of patients who underwent screening mammography with a "normal" or "benign" first-reading result. The main objective of the study is to evaluate the possibilities of subtracting from the second reading of breast cancer screening a population of examinations for which the risk of discovering cancer is close to zero, using an AI system (here the MammoScreen™ system).

Study Overview

Status

Completed

Conditions

Breast Cancer Female

Detailed Description

This is a retrospective multicenter study of mammography imaging data contained in the PACS (Picture Archiving and Communication System) of six radiology centers located in the Rhône, Puy de dôme, Cantal and Haute-Loire départements.

In order to be able to collect two-year follow-up data, the files analyzed will concern all women who received a screening mammogram during the years 2015, 2016, 2017, 2018 and 2019. More recent mammograms will be excluded.

Study Type

Observational

Enrollment (Actual)

55589

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Lyon, France, 69008
    - Hôpital privé Jean Mermoz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

As this was a retrospective exploratory study, with no prior hypothesis, the number of subjects required was not calculated.

The study population (n=55,000) represents, for the radiology practices concerned, all mammograms examined in second reading by the Auvergne Rhône Alpes regional cancer screening coordination center between 2015 and 2019.

Description

Inclusion Criteria:

Women aged 50 to 74 participating in the organized screening campaign.
Having had a screening mammogram with a final L1 result of "normal" (ACR 1/ BI-RADS 1) or "benign" (ACR 2/ BI-RADS 2).
For which a second reading interpretation is available
Screening mammograms performed during the years 2015 to2019 (In order to have follow-up data (subsequent mammogram or information on the person's future)

Exclusion Criteria:

- Mammography not performed as part of organized screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of real negatives Time Frame: Week 8	Percentage of cases negatived by MammoScreen (considered benign by the system), and for which no cancer was detected at the end of the L2 (according to the different risk levels of the MammoScreen software - score from 1 to 10). We distinguish two sub-populations: L2- and L2+ with BDD- (in addition to L2-).	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of real positives Time Frame: Week 8	Percentage of MammoScreen-positive cases for which cancer was detected in L2 (according to the different risk levels of the MammoScreen software - score from 1 to 10).	Week 8
Percentage of false negatives Time Frame: Week 8	Percentage of MammoScreen-positive cases with an L2 ultimately considered negative (L2- or L2 + with DBB-), for which interval cancer is detected (according to the different risk levels of the MammoScreen software - score from 1 to 10).	Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Collaborators

Vivactis M2Research

Investigators

Principal Investigator: Christophe TOURASSE, MD, Hôpital privé Jean Mermoz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Actual)