ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to measure the performance characteristics for the collection,
      fixation and transportation of clinical nipple aspirate fluid (NAF) specimens of the ForeCYTE
      Breast Aspirator across 3 independent labs and the National Reference Laboratory for Breast
      Health (NRLBH). The study hypothesis is that each lab will have a specimen acceptability rate
      of at least 90%. If it is assumed that the true level of acceptability testing is
      approximately 96%, then the lower bound of a one-sided 95% confidence interval is expected to
      be at least 90%.
    

Detailed description: 
      A) NAF Collection at physician's office: The Principle Investigator identified and qualified
      the study subjects. He and the assigned study coordinator from his clinic completed all
      entries in the Study Case Report Form related to the collection site. He collected the NAF
      specimens at the Physician Office Collection Sites in accordance with the Instructions for
      Use.

      B) NAF Processing at physician's office: The Principle Investigator's designate processed the
      NAF specimens for shipment to the selected laboratories in accordance with the Instructions
      for Use.

      C) NAF Transport from physician's office to laboratory: The patient specimen collection
      membranes were placed in resealable pouches, packed in shipping boxes (provided) and
      transported by Federal Express to the participating Independent Clinical Laboratories. The
      Federal Express packaging was pre-labeled for the PI within each of the four laboratories and
      the specimens were sent in the order in which they were collected to each of the
      laboratories. Left and right breast specimen from the same subject were sent to the same lab,
      but in a subject based sequence. The shipments will be shipped serially to lab ABCD, ABCD,
      ABCD, ABCD, etc. So specimens from subject 1 went to laboratory A, specimens from subject 2
      to lab B, specimens from subject 3 to lab C, specimens from subject 4 to lab D, specimens
      from subject 5 to lab A, etc. The PI completed the Testing Facility Shipping and Receiving
      Tracking Form for all specimens.

      D) NAF Processing at laboratory: The NAF was processed at the clinical cytology laboratories
      in accordance with the Instructions for Use that accompanied each patient kit.

      E) NAF Cytology Classification: A trained, board-certified pathologist read the slides. The
      data was reported in the Case Report Form according to the format recommended by the College
      of American Pathologists. The criteria for reading and interpreting the slides are contained
      in Table 2 and were adapted from King, et al. The laboratory portion of the Case Report Form
      was completed for each patient.
    

Intervention name(s): ForeCYTE Breast Aspirator
Intervention type(s): Device
Intervention description(s): ForeCYTE Breast Aspirator used for bilateral collection of Nipple Aspirate Fluid (NAF) for cytologic testing
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy women, ages 20 to 75 from whom bi-lateral NAF samples can be obtained.
      
Keywords: Nipple Aspirate Fluid; Breast Health Screening; Cytology