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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
The BARUCH PADEH Medical Center
Poria – Neve Oved, Lower Galilee, Israel
Ziv Medical Center
Safed, Upper Galilee, Israel
NAF cytological classification(s), according to the modified King Classification.
Time frame: 1 day (single time point)
The IBIS (Tyrer-Cuzick) risk score (10-year and lifetime breast cancer risk estimate.
Time frame: 1 day (single time point)
Safety, as reported by adverse events experienced after NAF collection with ForeCYTE Breast Aspirator
Time frame: 1 day (single time point)
micro-RNA (subgroup analysis of BRCA mutation carriers only)
development of micro-RNA panel that signals the transition to breast cancer
Time frame: 1 day (single time point)
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