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

Breast Neoplasms Clinical Trial

Official title:

A Single-arm, Multi-laboratory Clinical Trial of the ForeCYTE Breast Aspirator for Sample Collection, Processing and Cytological Testing of Nipple Aspirate Fluid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218385
• Other study ID #: GCP003
• Status: Completed
• Phase: N/A
• First received: July 30, 2014
• Last updated: October 18, 2016
• Start date: August 2014
• Est. completion date: August 2014

Study information

• Verified date: October 2016
• Source: Atossa Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Healthy, female, age 20-75 years, from whom bi-lateral specimens can be obtained.

2. Any woman for whom NAF cytology testing is considered to be beneficial by her physician.

3. Non-lactating and non-pregnant (as documented by date of Last Menstrual Period or post-menopausal).

4. Good general health as determined by medical history, breast disease/cancer history, and clinical breast exam.

5. Willing to give informed consent and follow study procedures as directed.

Exclusion Criteria:

1. Medical condition/psychiatric conditions making subjects a poor candidate for study, as determined by the Principal Investigator.

2. Pregnancy or suspicion of pregnancy.

3. Open cutaneous wounds or atopic dermatitis in the area of the nipple-areolar complex.

4. No or inverted nipple on the breast unfit for fluid collection, or significant prior surgery in the area of the nipple-areolar complex.

5. Participation in an investigational drug or device study less than 30 days prior to enrollment in this study.

6. Pregnancy, childbirth, or lactation less than 90 days prior to enrollment in this study.

7. Acute illness, including taking antibiotics, analgesics, antipyretics and/or cold medications less than 7 days prior to enrollment in this study.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Elite Women's Health	New Hyde Park	New York

Sponsors (5)

Lead Sponsor	Collaborator
Atossa Genetics, Inc.	National Reference Laboratory for Breast Health, Puget Sound Institute of Pathology, Quest Diagnostics, Sound Pathology Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety / Investigational Device Adverse Effects	Investigational Device Adverse Effects	Day of specimen collection	Yes