<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/NCT02995096</url>
  </required_header>
  <id_info>
    <org_study_id>There is no unique protocol ID</org_study_id>
    <nct_id>NCT02995096</nct_id>
  </id_info>
  <brief_title>Tumor Characteristics, Pre-transplant Treatments and Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma</brief_title>
  <official_title>The Effect of Tumor Characteristics, Pre-transplant Treatments and Immunosuppression on Survival After Liver Transplantation for Hepatocellular Carcinoma - a European Registry Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recurrence after liver transplantation for hepatocellular carcinoma (HCC) represents an&#xD;
      important cause of mortality for this surgical population. In addition to tumor&#xD;
      characteristics, It has been suggested that pre-treatment and sirolimus-based&#xD;
      immunosuppression may affect recurrence and survival. With data from the European Liver&#xD;
      Transplant Registry (ELTR) database, the aim of this study is to investigate the impact of&#xD;
      tumor characteristics, pre-transplant treatment and immunosuppression regimens on survival&#xD;
      after liver transplantation for HCC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">October 2018</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>Overall survival</measure>
    <time_frame>up to 10 year survival</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hepatocellular carcinoma specific survival</measure>
    <time_frame>5 year and 10 year survival</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">23124</enrollment>
  <condition>Liver Transplantation</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pre-treatment</intervention_name>
    <description>Non-transplantation pre-treatments prior to transplantation (e.g. radiofrequency ablation, transcatheter arterial chemoembolization)</description>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sirolimus based immunosuppression</intervention_name>
    <description>Immunosuppression regimens containing Sirolimus</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients receiving liver transplantation for hepatocellular carcinoma in European centers&#xD;
        reporting to the ELTR database.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hepatocellular carcinoma within transplantation criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disseminated disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hans-Christian Pommergaard, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Surgery and Transplantion, Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>March 31, 2019</last_update_submitted>
  <last_update_submitted_qc>March 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Hans-Christian Pommergaard, MD, PhD</investigator_full_name>
    <investigator_title>Resident</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sirolimus</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The database material is available for researcher applying for data</ipd_description>
  </patient_data>
  <!-- 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/NCT02995096
org study id: There is no unique protocol ID
nct id: NCT02995096
lead sponsor: 
has dmc: No
Recurrence after liver transplantation for hepatocellular carcinoma (HCC) represents an
      important cause of mortality for this surgical population. In addition to tumor
      characteristics, It has been suggested that pre-treatment and sirolimus-based
      immunosuppression may affect recurrence and survival. With data from the European Liver
      Transplant Registry (ELTR) database, the aim of this study is to investigate the impact of
      tumor characteristics, pre-transplant treatment and immunosuppression regimens on survival
      after liver transplantation for HCC.
observational model: Cohort
time perspective: Prospective
measure: Overall survival
time frame: up to 10 year survival
measure: Hepatocellular carcinoma specific survival
time frame: 5 year and 10 year survival
intervention type: Procedure
intervention name: Pre-treatment
description: Non-transplantation pre-treatments prior to transplantation (e.g. radiofrequency ablation, transcatheter arterial chemoembolization)
intervention type: Drug
intervention name: Sirolimus based immunosuppression
description: Immunosuppression regimens containing Sirolimus
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Hans-Christian Pommergaard, MD, PhD
role: Principal Investigator
affiliation: Dept. of Surgery and Transplantion, Rigshospitalet, Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Hans-Christian Pommergaard, MD, PhD
investigator title: Resident
mesh term: Carcinoma, Hepatocellular
mesh term: Sirolimus
sharing ipd: No
ipd description: The database material is available for researcher applying for data