- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02218385
ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid
A Single-arm, Multi-laboratory Clinical Trial of the ForeCYTE Breast Aspirator for Sample Collection, Processing and Cytological Testing of Nipple Aspirate Fluid
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New Hyde Park, New York, United States, 11042
- Elite Women's Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ForeCYTE Breast Aspirator
ForeCYTE Breast Aspirator used for bilateral collection of Nipple Aspirate Fluid (NAF) for cytologic testing
|
ForeCYTE Breast Aspirator used for bilateral collection of Nipple Aspirate Fluid (NAF) for cytologic testing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specimen Acceptance Rate
Time Frame: Within 2 weeks after specimen collection
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety / Investigational Device Adverse Effects
Time Frame: Day of specimen collection
|
Investigational Device Adverse Effects
|
Day of specimen collection
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonathan D. Herman, MD, FACOG, Elite Women's Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCP003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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