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/NCT06038110</url>
    </required_header>
    <id_info>
      <org_study_id>CIRB Ref:2022/2514</org_study_id>
      <nct_id>NCT06038110</nct_id>
    </id_info>
    <brief_title>Use of Axillary Ultrasound to Guide Breast Cancer Management in the Genomic Assay Era</brief_title>
    <official_title>Use of Axillary Ultrasound to Guide Breast Cancer Management in the Genomic Assay Era: A Retrospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>KK Women's and Children's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>KK Women's and Children's Hospital</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>
        The investigators aimed to determine if axillary ultrasound can reliably distinguish between&#xD;
        patients with limited or high nodal burden, so that the patients with limited nodal burden&#xD;
        can potentially avoid chemotherapy and instead receive upfront surgery followed by gene assay&#xD;
        testing.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 1, 2007</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>the number of abnormal nodes on ultrasound</measure>
      <time_frame>from the date of diagnosis to the date of surgery, up to 12 weeks</time_frame>
      <description>the number of abnormal nodes on ultrasound which was done at the time of diagnosis will be measured</description>
    </primary_outcome>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Axillary Ultrasound</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>axillary ultrasound</intervention_name>
      <description>usefulness of axillary ultrasound in predicting need for chemotherapy or upfront surgery</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Breast cancer patients with T1-3, HR-positive and HER2-negative disease, aged≥ 50 years&#xD;
          old, had axillary ultrasound prior to operation and axillary lymph node dissection&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  breast cancer patients with T1-3, HR-positive and HER2-negative disease.&#xD;
  &#xD;
            -  aged≥ 50 years old&#xD;
  &#xD;
            -  had axillary ultrasound prior to operation&#xD;
  &#xD;
            -  axillary lymph node dissection&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with neoadjuvant chemotherapy&#xD;
  &#xD;
            -  bilateral cancers&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>KK Women's and Children's Hospital</name>
        <address>
          <city>Singapore</city>
          <country>Singapore</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Singapore</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 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>
  
  
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/NCT06038110
  org study id: CIRB Ref:2022/2514
  nct id: NCT06038110
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The investigators aimed to determine if axillary ultrasound can reliably distinguish between
        patients with limited or high nodal burden, so that the patients with limited nodal burden
        can potentially avoid chemotherapy and instead receive upfront surgery followed by gene assay
        testing.
  observational model: Cohort
  time perspective: Retrospective
  measure: the number of abnormal nodes on ultrasound
  time frame: from the date of diagnosis to the date of surgery, up to 12 weeks
  description: the number of abnormal nodes on ultrasound which was done at the time of diagnosis will be measured
  intervention type: Diagnostic Test
  intervention name: axillary ultrasound
  description: usefulness of axillary ultrasound in predicting need for chemotherapy or upfront surgery
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 21 Years
  maximum age: 100 Years
  healthy volunteers: No
  facility: 
  country: Singapore
  responsible party type: Sponsor