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 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT00896857
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Agrees to undergo breast surgical procedure AND meets one of the following criteria:
* Scheduled to undergo breast biopsy based on suspicious mammographic or clinical breast examination findings
* Diagnosis of ductal carcinoma in situ (DCIS) or carcinoma in the breast to be studied (opposite breast may also be studied)
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Female
* Pre- or post-menopausal
* Not currently pregnant or pregnant within the past 12 months
* Must not have lactated within the past 12 months
* No active infection or inflammation in the breast to be studied
* No known allergy to lidocaine, prilocaine, or marcaine (bupivacaine)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior subareolar surgery or other breast procedure that may disrupt the ductal system within 2 cm of the nipple in the breast to be studied
* No prior breast implant that disrupts the ductal architecture in the breast to be studied
* No prior silicone injections in the breast to be studied
* No prior radiotherapy to the breast to be studied
* No chemotherapy within the past 6 months
* Concurrent prophylactic chemotherapy allowed
* No concurrent participation in another research study that may conflict with or affect the outcome of this study
Healthy Volunteers:
False
Sex:
FEMALE
Maximum Age:
120 Years
Study:
NCT00896857
Study Brief:
Protocol Section:
NCT00896857