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

NCT ID: NCT06479772

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55589 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-10

Study Completion Date

2024-03-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Breast Cancer Female

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Vivactis M2Research

INDUSTRY

Sponsor Role collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe TOURASSE, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Privé Jean Mermoz

Locations

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Hôpital Privé Jean Mermoz

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2021-06-051

Identifier Type: -

Identifier Source: org_study_id