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

NCT06479772 | Completed

• 1 other identifier: 2021-06-051
• Study Type: observational
• Target: 55,589
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• Percentage of real negatives

  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 Outcomes (2)

• Percentage of real positives

  Week 8

• Percentage of false negatives

  Week 8

Eligibility Criteria

• Age: 50 Years - 74 Years
• Gender Eligibility Details: Female breast cancer
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• \- Mammography not performed as part of organized screening

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Vivactis M2Research: collaborator

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

Study Officials

• Christophe TOURASSE, MD

  Hôpital Privé Jean Mermoz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: June 28, 2024
• Study Start: October 10, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

FR (1)