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/NCT06018857</url>
    </required_header>
    <id_info>
      <org_study_id>17-009</org_study_id>
      <nct_id>NCT06018857</nct_id>
    </id_info>
    <brief_title>Registry 17-009: Multi-Institutional Study Examining Patients With HCC Undergoing Liver Transplantation</brief_title>
    <official_title>Registry 17-009: Multi-Institutional Study Examining Patients With HCC Undergoing Liver Transplantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Federico Aucejo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ohio State University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The Cleveland Clinic</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 registry study examining patients with HCC undergoing liver transplantation&#xD;
        including outcomes and predictors of recurrence&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">May 11, 2017</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Recurrence Free Survival</measure>
      <time_frame>From date of surgery to date of identified cancer recurrence through either clinical judgement or scans. This is assessed up to 10 years after the surgery.</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall Survival</measure>
      <time_frame>From date of surgery to date of death, up to 10 years after the surgery.</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients (age&gt;18 years) undergoing Liver transplant for hepatocellular carcinoma&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients (age&gt;18 years) undergoing Liver transplant for hepatocellular carcinoma&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients under 18 years old&#xD;
  &#xD;
            -  Patients who do not have hepatocellular carcinoma&#xD;
  &#xD;
            -  patients who have hepatocellular carcinoma but do not undergo liver transplantation&#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>Federico Aucejo, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Cleveland Clinic</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Cleveland Clinic Foundation</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44195</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Ohio State University</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43210</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
      <investigator_full_name>Federico Aucejo</investigator_full_name>
      <investigator_title>Director Liver Cancer Program</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06018857
  org study id: 17-009
  nct id: NCT06018857
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a registry study examining patients with HCC undergoing liver transplantation
        including outcomes and predictors of recurrence
  observational model: Cohort
  time perspective: Retrospective
  measure: Recurrence Free Survival
  time frame: From date of surgery to date of identified cancer recurrence through either clinical judgement or scans. This is assessed up to 10 years after the surgery.
  measure: Overall Survival
  time frame: From date of surgery to date of death, up to 10 years after the surgery.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Federico Aucejo, MD
  role: Principal Investigator
  affiliation: The Cleveland Clinic
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: The Cleveland Clinic
  investigator full name: Federico Aucejo
  investigator title: Director Liver Cancer Program
  mesh term: Carcinoma, Hepatocellular
  sharing ipd: No