NCT02539615

Brief Summary

The purpose of this study is to measure the performance of the ForeCYTE Breast Aspirator for the collection and processing of Nipple Aspirate Fluid (NAF) specimens for cytology. Including collecting, processing and shipping samples, training staff, processing samples, sample interpretation and accurate and timely reporting in a manner resembling routine clinical use. The study will include a subset of patients who are known carriers of a BRCA germline mutation. NAF from this subset will be submitted for molecular testing in addition to cytology.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

3 months

First QC Date

September 1, 2015

Last Update Submit

January 21, 2016

Conditions

Breast Cancer, Preneoplastic Conditions, BRCA

Outcome Measures

Primary Outcomes (1)

  • NAF cytological classification(s), according to the modified King Classification.

    1 day (single time point)

Secondary Outcomes (3)

  • The IBIS (Tyrer-Cuzick) risk score (10-year and lifetime breast cancer risk estimate.

    1 day (single time point)

  • Safety, as reported by adverse events experienced after NAF collection with ForeCYTE Breast Aspirator

    1 day (single time point)

  • micro-RNA (subgroup analysis of BRCA mutation carriers only)

    1 day (single time point)

Study Arms (1)

ForeCYTE Breast Aspirator - Nipple Aspirate Fluid Collection

EXPERIMENTAL

Nipple Aspirate is collected using the ForeCYTE Breast Aspirator

Device: ForeCYTE Breast Aspirator

Interventions

ForeCYTE Breast AspiratorDEVICE
ForeCYTE Breast Aspirator - Nipple Aspirate Fluid Collection

Eligibility Criteria

Age30 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, female, age 30-55 years, from whom bi-lateral specimens can be obtained.
  • The following additional considerations apply:
  • Women with prior mastectomy/lumpectomy may be considered for NAF-collection in the contralateral (non-operated) breast only if they were:
  • Stage I or Stage II at the time of surgery;
  • Are considered disease-free (NED- No Evidence of Disease) at the time of study entry;
  • Women under the age 30 may be enrolled if they are within 10 years of the age at diagnosis of breast cancer in a first-degree relative. No subject under the age of 21 may be enrolled.
  • Any woman for whom NAF-cytology testing is considered to be beneficial by her physician. This includes, but is not limited to women with first- and/or second degree relatives with breast- or ovarian cancer. Known presence of a BRCA-1 or BRCA-2 germline mutation is allowed but not required. If known, any such mutation will be noted on the Case Report Form. The protocol does not provide for testing of women without known germ-line mutations.
  • Non-lactating and non-pregnant.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The BARUCH PADEH Medical Center

Poria – Neve Oved, Lower Galilee, 15208, Israel

Location

Ziv Medical Center

Safed, Upper Galilee, 13100, Israel

Location

MeSH Terms

Conditions

Breast NeoplasmsPrecancerous Conditions

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jelle Kylstra

    Atossa Therapeutics, Inc.

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 3, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

January 25, 2016

Record last verified: 2016-01

Locations

IL(2)