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Cytologic features of nipple aspirate fluid using an automated non-invasive collection device: a prospective observational study

DOI: 10.1186/1472-6874-5-10

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Abstract:

A multi-center prospective observational clinical trial involving asymptomatic women designed to assess fluid production, adequacy, safety and patient acceptance of the HALO NAF Collection System (NeoMatrix, Irvine, CA). Cytologic evaluation of all NAF samples was performed using previously described classification categories.500 healthy women were successfully enrolled. Thirty-eight percent (190/500) produced fluid and 187 were available for cytologic analysis. Cytologic classification of fluid producers showed 50% (93/187) Category 0 (insufficient cellular material), 38% (71/187) Category I (benign non-hyperplastic ductal epithelial cells), 10% (18/187) Category II (benign hyperplastic ductal epithelial cells), 3% (5/187) Category III (atypical ductal epithelial cells) and none were Category IV (unequivocal malignancy). Overall, 19% of the subjects produced NAF with adequate cellularity and 1% were found to have cytologic atypia.The HALO system is a simple, safe, rapid, automated method for standardized collection of NAF which is acceptable to patients. Cytologic assessment of HALO-collected NAF showed the ability to detect benign and pre-neoplastic ductal epithelial cells from asymptomatic volunteers.The majority of breast cancers originate in the epithelium lining the milk ducts. It is believed that most breast cancers are slow growing and progress from precancerous cells, which have cellular and nuclear changes that can be identified microscopically. Finding microscopic evidence of ductal epithelial atypia/atypical ductal hyperplasia (ADH) has been shown in previous epidemiologic studies to be a predictor of future breast cancer development in an individual woman. [1-10] This increased risk has been identified using random peri-areolar fine needle aspiration (FNA), tissue biopsy or nipple secretion samples for assessment of cytologic atypia.Nipple fluid or secretions, usually aspirated from the breast ducts, is a protein rich material termed nipple aspirate flu

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