ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid

NCT02218385 | Completed

• 1 other identifier: GCP003
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Breast Neoplasms

Keywords

Nipple Aspirate Fluid; Breast Health Screening; Cytology

Outcome Measures

Primary Outcomes (1)

• Specimen Acceptance Rate

  A specimen collected, fixated, shipped and received by the reference lab per specification, and rated by the receiving lab as acceptable for cytological testing and interpretation, is deemed acceptable.

  Within 2 weeks after specimen collection

Secondary Outcomes (1)

• Safety / Investigational Device Adverse Effects

  Day of specimen collection

Study Arms (1)

ForeCYTE Breast Aspirator

ForeCYTE Breast Aspirator used for bilateral collection of Nipple Aspirate Fluid (NAF) for cytologic testing

Device: ForeCYTE Breast Aspirator

Interventions

ForeCYTE Breast Aspirator DEVICE

ForeCYTE Breast Aspirator used for bilateral collection of Nipple Aspirate Fluid (NAF) for cytologic testing

ForeCYTE Breast Aspirator

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy women, ages 20 to 75 from whom bi-lateral NAF samples can be obtained.

You may qualify if:

• Healthy, female, age 20-75 years, from whom bi-lateral specimens can be obtained.
• Any woman for whom NAF cytology testing is considered to be beneficial by her physician.
• Non-lactating and non-pregnant (as documented by date of Last Menstrual Period or post-menopausal).
• Good general health as determined by medical history, breast disease/cancer history, and clinical breast exam.
• Willing to give informed consent and follow study procedures as directed.

You may not qualify if:

• Medical condition/psychiatric conditions making subjects a poor candidate for study, as determined by the Principal Investigator.
• Pregnancy or suspicion of pregnancy.
• Open cutaneous wounds or atopic dermatitis in the area of the nipple-areolar complex.
• No or inverted nipple on the breast unfit for fluid collection, or significant prior surgery in the area of the nipple-areolar complex.
• Participation in an investigational drug or device study less than 30 days prior to enrollment in this study.
• Pregnancy, childbirth, or lactation less than 90 days prior to enrollment in this study.
• Acute illness, including taking antibiotics, analgesics, antipyretics and/or cold medications less than 7 days prior to enrollment in this study.

Sponsors & Collaborators

• Atossa Therapeutics, Inc.: lead
• Quest Diagnostics-Nichols Insitute: collaborator
• National Reference Laboratory for Breast Health: collaborator
• Sound Pathology Associates: collaborator
• Puget Sound Institute of Pathology: collaborator

Study Sites (1)

Elite Women's Health

New Hyde Park, New York, 11042, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jonathan D. Herman, MD, FACOG

  Elite Women's Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: August 18, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

US (1)