<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02218385</url>
  </required_header>
  <id_info>
    <org_study_id>GCP003</org_study_id>
    <nct_id>NCT02218385</nct_id>
  </id_info>
  <brief_title>ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Atossa Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quest Diagnostics-Nichols Insitute</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Reference Laboratory for Breast Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sound Pathology Associates</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Puget Sound Institute of Pathology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Atossa Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to measure the performance characteristics for the collection,&#xD;
      fixation and transportation of clinical nipple aspirate fluid (NAF) specimens of the ForeCYTE&#xD;
      Breast Aspirator across 3 independent labs and the National Reference Laboratory for Breast&#xD;
      Health (NRLBH). The study hypothesis is that each lab will have a specimen acceptability rate&#xD;
      of at least 90%. If it is assumed that the true level of acceptability testing is&#xD;
      approximately 96%, then the lower bound of a one-sided 95% confidence interval is expected to&#xD;
      be at least 90%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A) NAF Collection at physician's office: The Principle Investigator identified and qualified&#xD;
      the study subjects. He and the assigned study coordinator from his clinic completed all&#xD;
      entries in the Study Case Report Form related to the collection site. He collected the NAF&#xD;
      specimens at the Physician Office Collection Sites in accordance with the Instructions for&#xD;
      Use.&#xD;
&#xD;
      B) NAF Processing at physician's office: The Principle Investigator's designate processed the&#xD;
      NAF specimens for shipment to the selected laboratories in accordance with the Instructions&#xD;
      for Use.&#xD;
&#xD;
      C) NAF Transport from physician's office to laboratory: The patient specimen collection&#xD;
      membranes were placed in resealable pouches, packed in shipping boxes (provided) and&#xD;
      transported by Federal Express to the participating Independent Clinical Laboratories. The&#xD;
      Federal Express packaging was pre-labeled for the PI within each of the four laboratories and&#xD;
      the specimens were sent in the order in which they were collected to each of the&#xD;
      laboratories. Left and right breast specimen from the same subject were sent to the same lab,&#xD;
      but in a subject based sequence. The shipments will be shipped serially to lab ABCD, ABCD,&#xD;
      ABCD, ABCD, etc. So specimens from subject 1 went to laboratory A, specimens from subject 2&#xD;
      to lab B, specimens from subject 3 to lab C, specimens from subject 4 to lab D, specimens&#xD;
      from subject 5 to lab A, etc. The PI completed the Testing Facility Shipping and Receiving&#xD;
      Tracking Form for all specimens.&#xD;
&#xD;
      D) NAF Processing at laboratory: The NAF was processed at the clinical cytology laboratories&#xD;
      in accordance with the Instructions for Use that accompanied each patient kit.&#xD;
&#xD;
      E) NAF Cytology Classification: A trained, board-certified pathologist read the slides. The&#xD;
      data was reported in the Case Report Form according to the format recommended by the College&#xD;
      of American Pathologists. The criteria for reading and interpreting the slides are contained&#xD;
      in Table 2 and were adapted from King, et al. The laboratory portion of the Case Report Form&#xD;
      was completed for each patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Specimen Acceptance Rate</measure>
    <time_frame>Within 2 weeks after specimen collection</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety / Investigational Device Adverse Effects</measure>
    <time_frame>Day of specimen collection</time_frame>
    <description>Investigational Device Adverse Effects</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">52</enrollment>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>ForeCYTE Breast Aspirator</arm_group_label>
    <description>ForeCYTE Breast Aspirator used for bilateral collection of Nipple Aspirate Fluid (NAF) for cytologic testing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ForeCYTE Breast Aspirator</intervention_name>
    <description>ForeCYTE Breast Aspirator used for bilateral collection of Nipple Aspirate Fluid (NAF) for cytologic testing</description>
    <arm_group_label>ForeCYTE Breast Aspirator</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy women, ages 20 to 75 from whom bi-lateral NAF samples can be obtained.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy, female, age 20-75 years, from whom bi-lateral specimens can be obtained.&#xD;
&#xD;
          2. Any woman for whom NAF cytology testing is considered to be beneficial by her&#xD;
             physician.&#xD;
&#xD;
          3. Non-lactating and non-pregnant (as documented by date of Last Menstrual Period or&#xD;
             post-menopausal).&#xD;
&#xD;
          4. Good general health as determined by medical history, breast disease/cancer history,&#xD;
             and clinical breast exam.&#xD;
&#xD;
          5. Willing to give informed consent and follow study procedures as directed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Medical condition/psychiatric conditions making subjects a poor candidate for study,&#xD;
             as determined by the Principal Investigator.&#xD;
&#xD;
          2. Pregnancy or suspicion of pregnancy.&#xD;
&#xD;
          3. Open cutaneous wounds or atopic dermatitis in the area of the nipple-areolar complex.&#xD;
&#xD;
          4. No or inverted nipple on the breast unfit for fluid collection, or significant prior&#xD;
             surgery in the area of the nipple-areolar complex.&#xD;
&#xD;
          5. Participation in an investigational drug or device study less than 30 days prior to&#xD;
             enrollment in this study.&#xD;
&#xD;
          6. Pregnancy, childbirth, or lactation less than 90 days prior to enrollment in this&#xD;
             study.&#xD;
&#xD;
          7. Acute illness, including taking antibiotics, analgesics, antipyretics and/or cold&#xD;
             medications less than 7 days prior to enrollment in this study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan D. Herman, MD, FACOG</last_name>
    <role>Principal Investigator</role>
    <affiliation>Elite Women's Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Elite Women's Health</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>October 18, 2016</last_update_submitted>
  <last_update_submitted_qc>October 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nipple Aspirate Fluid</keyword>
  <keyword>Breast Health Screening</keyword>
  <keyword>Cytology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02218385
org study id: GCP003
nct id: NCT02218385
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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%.
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.
time perspective: Prospective
measure: Specimen Acceptance Rate
time frame: Within 2 weeks after specimen collection
description: 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.
measure: Safety / Investigational Device Adverse Effects
time frame: Day of specimen collection
description: Investigational Device Adverse Effects
arm group label: ForeCYTE Breast Aspirator
description: ForeCYTE Breast Aspirator used for bilateral collection of Nipple Aspirate Fluid (NAF) for cytologic testing
intervention type: Device
intervention name: ForeCYTE Breast Aspirator
description: ForeCYTE Breast Aspirator used for bilateral collection of Nipple Aspirate Fluid (NAF) for cytologic testing
arm group label: ForeCYTE Breast Aspirator
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan D. Herman, MD, FACOG
role: Principal Investigator
affiliation: Elite Women's Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Undecided