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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT01501656
Eligibility Criteria:
Inclusion Criteria:
* Women between the ages of 30 and 79.
* Untreated stage 1 - 3 invasive breast cancer or a woman never diagnosed with breast cancer.
* BI-RADS 1, 2, or 3 breast imaging within 12 months for women \>40 years of age recruited into the control group.
Exclusion Criteria:
* \<30 or \>80 years of age
* Unable to provide informed consent
* Presence of an undefined palpable or mammographic breast lesion suspicious for malignancy (BIRADS 4 or 5)
* Breast implants
* Bilateral prophylactic mastectomy
* Any prior breasts irradiation
* Any systemic chemotherapy in the past
* Performance status that restricted normal activity for a significant portion of the day
* Use of luteinizing-hormone-releasing-hormone (LHRH) analogs, prolactin inhibitors, antiandrogens, or systemic glucocorticoids within three months
* Ever use of tamoxifen, raloxifene, or other SERMs
* Ever use of aromatase inhibitors
* Pregnancy or lactation within six months
* Bleeding diathesis of any kind
1. Inherited coagulation disorder
2. Current coumadin use
3. Use of drugs that inhibit platelet aggregation within 10 days
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
79 Years
Study:
NCT01501656
Study Brief:
Protocol Section:
NCT01501656