<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/NCT02243397</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-29691</org_study_id>
    <secondary_id>BRS0040</secondary_id>
    <nct_id>NCT02243397</nct_id>
  </id_info>
  <brief_title>Molecular and Cellular Analysis of Breast Cancer</brief_title>
  <official_title>Molecular and Cellular Analysis of Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate the different types and subtypes of cells found in&#xD;
      breast tumors. The investigators will do this using a variety of molecular analysis tools&#xD;
      that may allow for improved tests. The different types of cells in breast cancer impacts the&#xD;
      way individuals respond to various treatments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Safety&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>levels of GM-CSF in plasma</measure>
    <time_frame>10 years</time_frame>
    <description>We will be measuring levels of GM-CSF (Granulocyte-macrophayge colony stimulating factor) from the plasma of the patient before during and after the irradiation treatment to study if there is any increase in the GM-CSF production</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Breast - Female</condition>
  <condition>Breast - Male</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood, cerebrospinal fluid, abdominal fluid, chest fluid&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        breast cancer patients at Stanford Cancer Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically proven diagnosis of breast cancer or a carcinoma of unknown primary&#xD;
             consistent with the presentation of a primary breast malignancy.&#xD;
&#xD;
          2. 18 years of age or older.&#xD;
&#xD;
          3. Ability to understand and the willingness to sign a written informed consent do&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Minutes</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen Horst</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University Cancer Institute</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02243397
org study id: IRB-29691
secondary id: BRS0040
nct id: NCT02243397
lead sponsor: 
has dmc: No
The purpose of the study is to investigate the different types and subtypes of cells found in
      breast tumors. The investigators will do this using a variety of molecular analysis tools
      that may allow for improved tests. The different types of cells in breast cancer impacts the
      way individuals respond to various treatments.
observational model: Cohort
time perspective: Prospective
measure: levels of GM-CSF in plasma
time frame: 10 years
description: We will be measuring levels of GM-CSF (Granulocyte-macrophayge colony stimulating factor) from the plasma of the patient before during and after the irradiation treatment to study if there is any increase in the GM-CSF production
blood, cerebrospinal fluid, abdominal fluid, chest fluid
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Minutes
maximum age: N/A
healthy volunteers: No
last name: Kathleen Horst
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Sponsor