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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT04151368
Eligibility Criteria:
Inclusion Criteria:
* Women of any age with invasive breast cancer (BC), ductal carcinoma in situ (DCIS), BRCA or other breast cancer genetic mutation carriers or high risk BC female patients who are otherwise candidates for NSM with IPBR will be eligible for the study. For those patients, RNSM-IPBR will be offered. Those who, after thorough discussion of risks and benefits, choose and consent to undergo RNSM-IPBR will be included in the study.
Exclusion Criteria:
* Heavy smokers (\>20 cigarettes a day)
* Uncompensated Diabetes Mellitus
* High risk for anesthesia (ASA 4)
* Inflammatory Breast Cancer
* Previous thoracic radiation therapy for any reason
* Pregnancy
* Psychiatric, addictive, or any disorder which compromises ability to give informed consent for participation in this study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT04151368
Study Brief:
Protocol Section:
NCT04151368