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/NCT05972343</url>
    </required_header>
    <id_info>
      <org_study_id>202307067</org_study_id>
      <nct_id>NCT05972343</nct_id>
    </id_info>
    <brief_title>COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients</brief_title>
    <official_title>COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Washington University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Washington University School of Medicine</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a subject registry study of patients who undergo cryoablation for their breast cancer&#xD;
        after being determined not to be surgical candidates. Data collected as part of this registry&#xD;
        will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this&#xD;
        population as well as provide long-term follow-up of subjects who received cryoablation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 26, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2031</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2031</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>3 Years</target_duration>
    <primary_outcome>
      <measure>Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0</measure>
      <time_frame>Through 3 year follow-up</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients who demonstrate progression-free survival (PFS)</measure>
      <time_frame>At 3 year follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients who demonstrate disease-free survival (DFS)</measure>
      <time_frame>At 3 year follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients who demonstrate overall survival (OS)</measure>
      <time_frame>At 3 year follow-up</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Cancer of the Breast</condition>
    <arm_group>
      <arm_group_label>Cryoablation</arm_group_label>
      <description>Following pre-procedural imaging evaluation, patients will receive ultrasound-guided percutaneous cryoablation as part of their routine treatment of their breast cancer. Follow up imaging (if tolerated) will be performed at 6 months and 12 months and annually thereafter for until 3 years post-procedure. Data will be collected on patient demographics, disease characteristics, treatment, treatment complications, follow-up imaging, response (for 3 years post-procedure), and quality of life.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Cryoablation</intervention_name>
      <description>Takes place at single time point.</description>
      <arm_group_label>Cryoablation</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients seen at Siteman Cancer Center.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Eligibility Criteria:&#xD;
  &#xD;
            -  Diagnosis of breast cancer.&#xD;
  &#xD;
            -  Mass must be visible on ultrasound and &gt; 5 mm from skin.&#xD;
  &#xD;
            -  Not undergoing surgery, because:&#xD;
  &#xD;
                 -  Patient has a medical condition that would not allow sedation or general&#xD;
                    anesthesia&#xD;
  &#xD;
                 -  Surgery is not clinically indicated due to unresectable and/or metastatic disease&#xD;
  &#xD;
                 -  Surgery is not clinically indicated for another reason&#xD;
  &#xD;
                 -  Patient declines surgery&#xD;
  &#xD;
            -  At least 18 years old.&#xD;
  &#xD;
            -  Able to understand and willing to sign an IRB-approved written informed consent&#xD;
               document.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Heather Garrett, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Washington University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Heather Garrett, M.D.</last_name>
      <phone>314-454-5206</phone>
      <email>hvgarrett@wustl.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Washington University School of Medicine</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63110</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Heather Garrett, M.D.</last_name>
        <phone>314-454-5206</phone>
        <email>hvgarrett@wustl.edu</email>
      </contact>
      <investigator>
        <last_name>Heather Garrett, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Debbie Bennett, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Julie Margenthaler, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Katherine Clifton, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Mariya Kristeva, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jingqin Luo, Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Christina Doherty, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tabassum Ahmad, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.siteman.wustl.edu</url>
      <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>Yes</sharing_ipd>
      <ipd_description>In addition to the analyses proposed in this protocol, the data collected under this registry will be stored for potential (currently unknown) research projects and may be used to query for feasibility of future projects and other quality initiatives.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_access_criteria>Requests from individuals outside Washington University will require a formal data use agreement (DUA) before release of data for limited data sets and/or identifiable data sets.</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT05972343
  org study id: 202307067
  nct id: NCT05972343
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a subject registry study of patients who undergo cryoablation for their breast cancer
        after being determined not to be surgical candidates. Data collected as part of this registry
        will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this
        population as well as provide long-term follow-up of subjects who received cryoablation.
  observational model: Cohort
  time perspective: Prospective
  measure: Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0
  time frame: Through 3 year follow-up
  measure: Proportion of patients who demonstrate progression-free survival (PFS)
  time frame: At 3 year follow-up
  measure: Proportion of patients who demonstrate disease-free survival (DFS)
  time frame: At 3 year follow-up
  measure: Proportion of patients who demonstrate overall survival (OS)
  time frame: At 3 year follow-up
  arm group label: Cryoablation
  description: Following pre-procedural imaging evaluation, patients will receive ultrasound-guided percutaneous cryoablation as part of their routine treatment of their breast cancer. Follow up imaging (if tolerated) will be performed at 6 months and 12 months and annually thereafter for until 3 years post-procedure. Data will be collected on patient demographics, disease characteristics, treatment, treatment complications, follow-up imaging, response (for 3 years post-procedure), and quality of life.
  intervention type: Device
  intervention name: Cryoablation
  description: Takes place at single time point.
  arm group label: Cryoablation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Heather Garrett, M.D.
  role: Principal Investigator
  affiliation: Washington University School of Medicine
  last name: Heather Garrett, M.D.
  phone: 314-454-5206
  email: hvgarrett@wustl.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  url: http://www.siteman.wustl.edu
  description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: Yes
  ipd description: In addition to the analyses proposed in this protocol, the data collected under this registry will be stored for potential (currently unknown) research projects and may be used to query for feasibility of future projects and other quality initiatives.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd access criteria: Requests from individuals outside Washington University will require a formal data use agreement (DUA) before release of data for limited data sets and/or identifiable data sets.