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 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT03715959
Eligibility Criteria:
Inclusion Criteria:
* BREAST CANCER: Must be \> 1 year from pregnancy, lactation.
* BREAST CANCER: Must be currently diagnosed with known breast cancer in breast.
* BREAST CANCER: Must not be currently diagnosed with cancers other than breast cancer.
* BREAST CANCER: Must not have been gone through surgery, radiotherapy or chemotherapy within 30 days of enrollment.
* HEALTHY SUBJECTS: No history of breast cancer and must not be currently diagnosed with any other cancer.
* HEALTHY SUBJECTS: Must be \> 1 year from pregnancy, lactation.
* HEALTHY SUBJECTS: Must be willing to have a clinical breast exam and/or mammogram performed or reviewed by an Ohio State University (OSU) radiologist at the James Cancer Hospital within the past 90 days prior to their NAF procedure. The clinical breast exam result and/or mammograms must be read as not suspicious for breast cancer.
* HEALTHY SUBJECTS: Must be willing to keep the clinic informed of their breast health status for 1 year.
Exclusion Criteria:
* Subjects who are currently pregnant, lactating, or within a year of pregnancy/lactation. Pregnancy testing will not be required of any patients over 60 years of age, or any patient who has undergone bilateral oophorectomy.
* Subjects who currently are diagnosed with cancers other than breast cancer.
* Subjects who cannot give an informed consent.
* Male gender of any age.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT03715959
Study Brief:
Protocol Section:
NCT03715959