Clinical Validation of an Artificial Intelligence Algorithm to Help Interpret Mammograms (ALGO-MAMMO)

November 7, 2023 updated by: University Hospital, Strasbourg, France

This aims to clinically validate, on a large population, a tumor detection aid software which has already been trained on a representative French population (from several hospital centers and liberals from several departments in the west and east of France).

This population consists of 1000 patients who have been treated for breast cancer (histologically proven by breast biopsy) and whose investigators have mammograms performed at the time of diagnosis. The control population consists of the unaffected breast of each patient (with the exception of the rare cases of bilateral cancers).

This innovative software has the main feature of recognizing healthy breast tissue, allowing the radiologist to focus on breast tissue at risk, improving the management of medical time and the management of "difficult" files.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1000

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
      • Strasbourg, France, 67091
        • Service de Radiologie 1 - CHU de Strasbourg - France

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

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult woman (40 to 75 years old) treated at the University Hospitals of Strasbourg between 2010 and 2020 for breast cancer

Description

Inclusion Criteria:

  • Adult woman (40 to 75 years old)
  • Treatment at the University Hospitals of Strasbourg between 2010 and 2020 for breast cancer
  • including mammography and histological evidence available
  • Patient who has already given her consent for the reuse of her anonymous data for research purposes

Exclusion Criteria:

  • Woman who expressed her opposition to participating in the study

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the diagnostic performance (sensitivity, specificity) for operator tumor detection assisted by mammographic diagnostic aid software, and compare it to the diagnostic performance of an unassisted operator.
Time Frame: Files analysed retrospectively from January 01, 2010 to January 01, 2020 will be examined
This assessment is based on contouring the tumor area on mammograms.
Files analysed retrospectively from January 01, 2010 to January 01, 2020 will be examined

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

April 20, 2021

Primary Completion (Actual)

March 20, 2023

Study Completion (Actual)

May 20, 2023

Study Registration Dates

First Submitted

November 25, 2022

First Submitted That Met QC Criteria

November 25, 2022

First Posted (Actual)

December 7, 2022

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7964

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe