Breast Cancer FemaleELIASNCT06479772
Evaluation of the Potential Impact of an Artificial Intelligence Solution in Second Reading of Organized Screening.
An observational study of Breast Cancer Female, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- How many people
- 55,589 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2023to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Mammography not performed as part of organized screening
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Breast Cancer Female
What is being measured
The primary outcome is the main question the study is designed to answer.
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-).
Measured: Week 8
Secondary outcomes (2)
Percentage of real positives
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).
Measured: Week 8
Percentage of false negatives
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).
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start10 Oct 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 55,589 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Vivactis M2Research
- Responsible party
- Sponsor
- Investigators
- Christophe TOURASSE, MD, Principal investigator, Hôpital Privé Jean Mermoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479772
- Sponsor's protocol ID
- 2021-06-051
- Acronym
- ELIAS
- Status last verified
- Jun 2024
- First submitted
- 15 Dec 2023
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Potential Impact of an Artificial Intelligence Solution in Second Reading of Organized Screening.
- ClinicalTrials.gov ID
- NCT06479772
- Acronym / sponsor ID
- ELIAS / 2021-06-051
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55,589 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Vivactis M2Research
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Mammography not performed as part of organized screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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-).
2 secondary outcomes
Percentage of real positives
Time frame: Week 8
Percentage of false negatives
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe TOURASSE, MD principal investigator
Hôpital Privé Jean Mermoz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of real negatives (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.