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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT00859157
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following:
* Invasive (ductal or lobular) breast cancer
* In situ (ductal) breast cancer
* Stage 0-III disease
* Localized disease
* Candidate for curative mastectomy and selected mastectomy or modified radical mastectomy for surgical option of treatment at the University of California Davis Medical Center
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* WBC ≥ 1,500/mm\^3
* Platelet count ≥ 90,000/mm\^3
* PT/PTT ≤ upper limit of normal (ULN)
* Creatinine ≤ 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* No NYHA cardiac disease class III-IV
* Cancer survivors must have undergone potentially curative therapy for all prior malignancies with no evidence of prior malignancy within the last 5 years, except for effectively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix treated by surgery alone, or lobular carcinoma in situ of the breast treated by surgery alone
* Body Mass Index ≤ 40
PRIOR CONCURRENT THERAPY:
* No prior major breast surgery, including breast augmentation or reduction surgery
* No preoperative chemotherapy or radiotherapy
* No concurrent immediate breast reconstruction
* No concurrent bilateral mastectomy
* No concurrent narcotic pain medication
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00859157
Study Brief:
Protocol Section:
NCT00859157