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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT06512350
Eligibility Criteria:
Inclusion Criteria:
* Female (sex as assigned at birth);
* Aged 40 - 74 years;
* Mammography confirmed dense breast tissue (BI-RADS density score of C or D);
* Scheduled for standard of care biopsy or MRI;
* Fluent in language of consent (English, Spanish, or French);
* Ability to give informed consent;
* Able to provide a breath sample.
Exclusion Criteria:
* Mammography confirmed fatty breast tissue (BI-RADS A or B);
* Prior history of breast cancer;
* Previous surgical biopsy or surgical excision of breast cancer in the past six months;
* History of cancer (except basal cell or squamous cell carcinoma of the skin) in the past year;
* Acute respiratory infection and/or symptoms in the past seven days;
* MRI BI-RADS 3 undergoing active surveillance (MRI requiring six-month follow-up).
* Pregnant or become pregnant during the study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
74 Years
Study:
NCT06512350
Study Brief:
Protocol Section:
NCT06512350