xml: <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/NCT06011824</url>
    </required_header>
    <id_info>
      <org_study_id>23-004958</org_study_id>
      <nct_id>NCT06011824</nct_id>
    </id_info>
    <brief_title>A Study of Effect of Megakaryocytes and Platelets in Breast Cancer</brief_title>
    <official_title>Megakaryocytes and Platelets, Harmful or Helpful in Breast Cancer Cell Metastasis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Determining if Megakaryocytes and Platelets are Harmful or Helpful in Breast Cancer Cell&#xD;
        Metastasis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to determine how megakaryocytes (cells in the bone marrow&#xD;
        responsible for making platelets, which are necessary for blood clotting) affect the survival&#xD;
        and growth/division patterns of breast cancer stem cells, and the effects of breast cancer&#xD;
        cells on megakaryocyte survival and function. Through chart review, the study team will look&#xD;
        at the relationship between different blood components and different breast cancer diagnoses.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2028</completion_date>
    <primary_completion_date type="Anticipated">September 2028</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>Platelet Counts</measure>
      <time_frame>Baseline</time_frame>
      <description>Measure of the number of platelets in the blood, reported as platelets per microliter of blood.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean Corpuscular Volume (MCV)</measure>
      <time_frame>Baseline</time_frame>
      <description>Measures the average size of red blood cells, reported as femtoliters (fl).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lymphocyte to neutrophil ratio</measure>
      <time_frame>Baseline</time_frame>
      <description>Ratio between the neutrophil and lymphocyte counts measured in peripheral blood.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Levels of tumor educated platelets</measure>
      <time_frame>Baseline</time_frame>
      <description>Number of tumor educated platelets, measured by the analysis of cell surface markers for expression of certain markers such as VEGF, PDGFR, MMP1, TGFb, and or other cell adhesion molecules.</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Biopsy Negative</arm_group_label>
      <description>Female age 18 and above with negative breast biopsy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Biopsy positive for carcinoma in situ (ductal, lobular, or other)</arm_group_label>
      <description>Females age 18 and above with any subtype of breast cancer (ductal, lobular, or other)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)</arm_group_label>
      <description>Females age 18 and above with any subtype of breast cancer (HER2+, ER/PR, TNBC, BRCA1 +/-, other).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Metastatic Stage IV</arm_group_label>
      <description>Females age 18 and above with any subtype of breast cancer, including metastases</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Blood draw</intervention_name>
      <description>10-12mL of blood will be drawn one time, unless a redraw is needed, in which case up to 24 mL will be drawn (10-12 mL each draw)</description>
      <arm_group_label>Biopsy Negative</arm_group_label>
      <arm_group_label>Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)</arm_group_label>
      <arm_group_label>Biopsy positive for carcinoma in situ (ductal, lobular, or other)</arm_group_label>
      <arm_group_label>Metastatic Stage IV</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood draw. 10-12 mL total into lavender-top (EDTA) tubes, however up to 24 mL may be&#xD;
        obtained should a redraw be needed.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          For the prospective study: 20 women after biopsy for suspicious mammogram findings, 10&#xD;
          women with newly diagnosed metastatic cancer.&#xD;
  &#xD;
          Subject population (children, adults, groups): Women undergoing biopsy or suspicious&#xD;
          mammogram finds and newly diagnosed female metastatic breast cancer patients.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Cohort 1-Biopsy negative&#xD;
  &#xD;
          -Females age 18 and above&#xD;
  &#xD;
          Cohort 2-Biopsy positive for carcinoma in situ (ductal, lobular, or other)&#xD;
  &#xD;
            -  Females age 18 and above&#xD;
  &#xD;
            -  Any subtype of breast cancer&#xD;
  &#xD;
          Cohort 3-Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or&#xD;
          other)&#xD;
  &#xD;
            -  Females age 18 and above&#xD;
  &#xD;
            -  Any subtype of breast cancer&#xD;
  &#xD;
            -  Have no distant metastases&#xD;
  &#xD;
          Cohort 4-Stage 4 Metastatic Disease&#xD;
  &#xD;
            -  Females age 18 and above&#xD;
  &#xD;
            -  Any subtype of breast cancer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Cohort 1-Biopsy negative&#xD;
  &#xD;
            -  Males&#xD;
  &#xD;
            -  Females less than age 18&#xD;
  &#xD;
          Cohort 2-Biopsy positive for carcinoma in situ (ductal, lobular, or other)&#xD;
  &#xD;
            -  Males&#xD;
  &#xD;
            -  Females less than age 18&#xD;
  &#xD;
            -  Currently undergoing neoadjuvant therapy&#xD;
  &#xD;
          Cohort 3-Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or&#xD;
          other)&#xD;
  &#xD;
            -  Males&#xD;
  &#xD;
            -  Females less than age 18&#xD;
  &#xD;
            -  Presence of distant metastases&#xD;
  &#xD;
            -  Currently undergoing neoadjuvant therapy&#xD;
  &#xD;
          Cohort 4-Stage 4 Metastatic Disease&#xD;
  &#xD;
            -  Males&#xD;
  &#xD;
            -  Females less than age 18&#xD;
  &#xD;
            -  Currently undergoing neoadjuvant therapy&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Biological females</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Scott H. Okuno, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic Health System-Franciscan Healthcare</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-776-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Leandra Pake</last_name>
      <phone>608-392-9719</phone>
      <email>Franzen.Leandra@mayo.edu</email>
    </overall_contact_backup>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Megakaryocytes</keyword>
    <keyword>Platelets</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011824
  org study id: 23-004958
  nct id: NCT06011824
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Determining if Megakaryocytes and Platelets are Harmful or Helpful in Breast Cancer Cell
        Metastasis
  The purpose of this study is to determine how megakaryocytes (cells in the bone marrow
        responsible for making platelets, which are necessary for blood clotting) affect the survival
        and growth/division patterns of breast cancer stem cells, and the effects of breast cancer
        cells on megakaryocyte survival and function. Through chart review, the study team will look
        at the relationship between different blood components and different breast cancer diagnoses.
  observational model: Cohort
  time perspective: Prospective
  measure: Platelet Counts
  time frame: Baseline
  description: Measure of the number of platelets in the blood, reported as platelets per microliter of blood.
  measure: Mean Corpuscular Volume (MCV)
  time frame: Baseline
  description: Measures the average size of red blood cells, reported as femtoliters (fl).
  measure: Lymphocyte to neutrophil ratio
  time frame: Baseline
  description: Ratio between the neutrophil and lymphocyte counts measured in peripheral blood.
  measure: Levels of tumor educated platelets
  time frame: Baseline
  description: Number of tumor educated platelets, measured by the analysis of cell surface markers for expression of certain markers such as VEGF, PDGFR, MMP1, TGFb, and or other cell adhesion molecules.
  arm group label: Biopsy Negative
  description: Female age 18 and above with negative breast biopsy
  arm group label: Biopsy positive for carcinoma in situ (ductal, lobular, or other)
  description: Females age 18 and above with any subtype of breast cancer (ductal, lobular, or other)
  arm group label: Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)
  description: Females age 18 and above with any subtype of breast cancer (HER2+, ER/PR, TNBC, BRCA1 +/-, other).
  arm group label: Metastatic Stage IV
  description: Females age 18 and above with any subtype of breast cancer, including metastases
  intervention type: Other
  intervention name: Blood draw
  description: 10-12mL of blood will be drawn one time, unless a redraw is needed, in which case up to 24 mL will be drawn (10-12 mL each draw)
  arm group label: Biopsy Negative
  arm group label: Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)
  arm group label: Biopsy positive for carcinoma in situ (ductal, lobular, or other)
  arm group label: Metastatic Stage IV
  Blood draw. 10-12 mL total into lavender-top (EDTA) tubes, however up to 24 mL may be
        obtained should a redraw be needed.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Biological females
  minimum age: 18 Years
  maximum age: N/A
  last name: Scott H. Okuno, M.D.
  role: Principal Investigator
  affiliation: Mayo Clinic Health System-Franciscan Healthcare
  last name: Clinical Trials Referral Office
  phone: 855-776-0015
  email: mayocliniccancerstudies@mayo.edu
  last name: Leandra Pake
  phone: 608-392-9719
  email: Franzen.Leandra@mayo.edu
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Sponsor
  mesh term: Breast Neoplasms