Spots Global Cancer Trial Database for A Trial of the ForeCYTE Breast Aspirator for Cytological Testing of Nipple Aspirate Fluid in Women 30-55 Years Old
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Trial Identification
Brief Title: A Trial of the ForeCYTE Breast Aspirator for Cytological Testing of Nipple Aspirate Fluid in Women 30-55 Years Old
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
Study ID: NCT02539615
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 30 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
The BARUCH PADEH Medical Center, Poriya, Lower Galilee, Israel
Ziv Medical Center, Zefat, Upper Galilee, Israel
Contact Details
Name: Jelle Kylstra
Affiliation: Atossa Therapeutics, Inc.
Role: STUDY_DIRECTOR
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