Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT05800132
Eligibility Criteria:
Inclusion Criteria:
* Affiliated to the French social security system
* Whose mammograms meet the following characteristics: 4 (2 per breast, CC and MLO) meeting local regulatory standards and with correct DICOM metadata,
* Whose mammograms have been determined to be normal or to have benign lesions by the radiologist who performed the first reading of the images (L1) in the framework of the organized breast cancer screening program
* Having expressed her willingness to participate in the study, to undergo all the procedures and to make herself available for the expected duration of their participation,
* Having completed and signed the informed consent form.
Exclusion Criteria:
* Woman with breast implants,
* With clinical symptoms of breast cancer,
* With a history of breast surgery (breast reduction or surgery for benign lesion),
* Pregnant or breastfeeding,
* With medical conditions that may interfere with her ability to understand the requirements of the protocol or give informed consent,
* Deprived of liberty by judicial or administrative order,
* Participant whose mammogram images have at least one of the following defects: poor quality of the images, non-standard mammography (projection, magnification, compression), ML/LM/SIO/XCCL or XCCM view.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
74 Years
Study:
NCT05800132
Study Brief:
Protocol Section:
NCT05800132