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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT04097366
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to give written informed consent
* Willing and able to comply with the scheduled study visits, tests and other procedures
* Female
* Screening mammogram that is either normal or being recalled for assessment
* Increased breast density identified on current screening mammogram examination (BIRADS C or D)
* If BIRADS C the reporting radiologist should use clinical judgement as to eligibility, there should be a high chance of a cancer being masked in this participant
* All BIRADS D will be eligible
* Aged 50-70 and eligible for 3-yearly NHS breast screening
Exclusion Criteria:
* Known BRCA carrier or ≥50% risk of being a carrier
* Unable to give informed consent
* Breast implant(s)
* Unable to be followed-up for the study duration
* Current participation in another interventional breast screening trial (Including but not limited to MyPeBS)
* Participated in part A of the BRAID study
* Pregnant or breast feeding
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT04097366
Study Brief:
Protocol Section:
NCT04097366