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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT04537312
Eligibility Criteria:
Inclusion Criteria:
* Surgical candidates, per standard of care for:
* Nipple sparing resection and reconstruction OR
* Prophylactic mastectomy for risk reduction mastectomy OR
* Treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer
* Surgical candidates for open NSM, per standard of care, with regards to patient anatomic factors and tumor location
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
* Pregnant or nursing women
* Patients with:
* Inflammatory breast cancer
* Skin involvement with tumor
* Pre-operative diagnosis (radiological or pathologic) of nipple-areola complex involvement with tumor
* Grade 3 ptosis of nipple
* Smokers with heavy current use of nicotine (defined as \> 20 cigarettes/day)
* Patients that are high risk for anesthesia, as documented in medical record
* Patients that do not have the ability to give informed consent
* Prisoner status at surgical clinic visit
* Bra cup size greater than C cup
* Previous thoracic radiation history (for any reason)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04537312
Study Brief:
Protocol Section:
NCT04537312