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:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-25 @ 5:18 AM
NCT ID:
NCT00539227
Eligibility Criteria:
Inclusion Criteria:
1. Patients desiring prophylactic mastectomy with immediate reconstruction
2. Patients with Stage 0, I, or II breast cancer who are candidates for and desire skin-sparing mastectomy with immediate reconstruction
3. Tumor location greater than or equal to 2.5 cm from the border of the NAC based on preoperative imaging and/or clinical exam
4. Patients must sign an informed consent and be registered before the procedure is performed
Exclusion Criteria:
1. Patients with cancer involvement of the NAC on clinical exam, defined as induration, retraction, fixation, ulceration, or pathologic nipple discharge
2. Patients with subareolar tumor locations, tumors located \< 2.5 cm from the border of the NAC
3. Patients with Paget's disease of the nipple
4. Patients who have locally advanced breast cancer manifesting as inflammatory breast cancer or gross involvement of the mastectomy skin
5. Patients with history of prior surgery involving a periareolar incision
6. Patients desiring a concomitant ipsilateral reduction mammoplasty at time of mastectomy
7. Patients with macromastia as defined by the plastic surgeon
8. Patients with a body mass index (BMI) greater than 40 kg/m2
9. Patients who actively smoke
10. Patients with known collagen vascular disease
11. Patients with prior ipsilateral chest wall irradiation less than 12 months from their time of surgery
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00539227
Study Brief:
Protocol Section:
NCT00539227