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:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT02197000
Eligibility Criteria:
Inclusion Criteria:
* Women who carrier the BRCA 1\\2 mutation.
* No history of breast or ovarian malignancy.
* i. Baseline mammographic breast density is more than 10% OR ii. Baseline breast MRI with density or enhancement ≤ 2.
* Age 18-70.
* Absence of any psychological, familial, sociological or geographical situation potentially hampering adherence to the study protocol and follow-up schedule.
* Informed written consent must be signed according to ICH/EU GCP, before subject registration.
Exclusion Criteria:
* Women who have undergone preventive breast reduction.
* Breast imaging demonstrating a lesion suspected to be cancerous.
* Breast feeding or Pregnancy or planning to get pregnant.
* Known allergy to DIM and its ingredients.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02197000
Study Brief:
Protocol Section:
NCT02197000