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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT03383835
Eligibility Criteria:
Inclusion Criteria:
* Women age 21 - 40 must be pre-menopausal as defined as having intact ovaries with regular menses or if not menstruating, have a premenopausal status confirmed by serum follicle-stimulating hormone (FSH) and estradiol.
* Women must be considered at high risk for breast cancer based on family history (first or second degree relative diagnosed with breast cancer under the age of 60), prior precancerous biopsy or a 5-year Gail model risk estimate of ≥ 1.7% or 10 year Tyrer-Cuzick risk of 2x population risk as listed in the model.
* Women must indicate that they are still considering future pregnancy and childbearing.
* Women must be one year from pregnancy and breast-feeding.
* Women must be willing to take supplemental omega-3 fatty acids provided by the study.
Exclusion Criteria:
* Women actively undergoing in-vitro fertilization or fertility treatments are excluded.
* Women currently pregnant or breast-feeding at time of study consent.
* Women with an active malignancy.
* Women on anticoagulation.
* Women with bilateral breast implants or tram flap reconstruction.
* Women who have had radiation to both breasts.
* Women with current mammographic or clinical breast exam mass which is suspicious for breast cancer and malignancy has not been ruled out.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
40 Years
Study:
NCT03383835
Study Brief:
Protocol Section:
NCT03383835