Breast Cancer, Preneoplastic Conditions, BRCA Clinical Trial
Official title:
A Single-arm, Multi-center Trial of the ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid in Women 30-55 Years of Age
The purpose of this study is to measure the performance of the ForeCYTE Breast Aspirator for the collection and processing of Nipple Aspirate Fluid (NAF) specimens for cytology. Including collecting, processing and shipping samples, training staff, processing samples, sample interpretation and accurate and timely reporting in a manner resembling routine clinical use. The study will include a subset of patients who are known carriers of a BRCA germline mutation. NAF from this subset will be submitted for molecular testing in addition to cytology.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening