<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/NCT03254121</url>
  </required_header>
  <id_info>
    <org_study_id>SAleman</org_study_id>
    <nct_id>NCT03254121</nct_id>
  </id_info>
  <brief_title>Genome Studies of Hepatocellular Carcinoma Developed in Hepatitis C Patients With Sustained Virological Response</brief_title>
  <acronym>HEPCASUS</acronym>
  <official_title>Genome Studies of Hepatocellular Carcinoma Developed in Hepatitis C Patients With Sustained Virological Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</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>
      In this international collaboration study, the research group will analyze somatic mutations&#xD;
      of hepatocellular carcinoma (HCC) developed after sustained virological response (SVR) in&#xD;
      patients treated with hepatitis C (HCV) therapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Method Paired liver tissue samples will be collected from the tumour sections and also from&#xD;
      the adjacent non-tumour tissues, for comparison in each individual. The tissues have been&#xD;
      collected as part of routine clinical work/other studies, by liver biopsies or at liver&#xD;
      resection/liver transplantation. Data regarding the patient characteristic will be collected.&#xD;
      Whole genome sequencing analyses are planned to be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Characterisation of genomic mutations of HCC, developed in HCV patients with SVR</measure>
    <time_frame>5 years</time_frame>
    <description>Genetic characteristics of HCCs will be compared to non-HCC tissue</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">93</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Patients with SVR and developed HCC</arm_group_label>
    <description>HCV patients with SVR and developed HCC plus available tissue from HCC</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Liver tissue from HCC and adjacent non-HCC&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Please see eligibility criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with sustained virological response (SVR) after interferon (IFN)-containing&#xD;
             or IFN-free treatment, and developed hepatocellular carcinoma (HCC)&#xD;
&#xD;
          -  Available liver biopsies from hepatocellular carcinoma and non-HCC tissue&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-infection with chronic hepatitis B (HBsAg positive) or HIV infection.&#xD;
&#xD;
          -  Liver transplantation prior to treatment-start, leading to SVR.&#xD;
&#xD;
          -  Patients with diagnosed HCC prior to treatment-start, leading to SVR.&#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>Jan Bolinder, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska Institutet</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Soo Aleman</investigator_full_name>
    <investigator_title>MD, PhD, Assoc prof</investigator_title>
  </responsible_party>
  <keyword>Sustained virological response</keyword>
  <keyword>Whole genome sequencing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual IPD will not be shared with other researchers</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/NCT03254121
org study id: SAleman
nct id: NCT03254121
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this international collaboration study, the research group will analyze somatic mutations
      of hepatocellular carcinoma (HCC) developed after sustained virological response (SVR) in
      patients treated with hepatitis C (HCV) therapy
Method Paired liver tissue samples will be collected from the tumour sections and also from
      the adjacent non-tumour tissues, for comparison in each individual. The tissues have been
      collected as part of routine clinical work/other studies, by liver biopsies or at liver
      resection/liver transplantation. Data regarding the patient characteristic will be collected.
      Whole genome sequencing analyses are planned to be performed.
observational model: Cohort
time perspective: Other
measure: Characterisation of genomic mutations of HCC, developed in HCV patients with SVR
time frame: 5 years
description: Genetic characteristics of HCCs will be compared to non-HCC tissue
arm group label: Patients with SVR and developed HCC
description: HCV patients with SVR and developed HCC plus available tissue from HCC
Liver tissue from HCC and adjacent non-HCC
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan Bolinder, Prof
role: Study Chair
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Soo Aleman
investigator title: MD, PhD, Assoc prof
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Hepatitis
sharing ipd: No
ipd description: Individual IPD will not be shared with other researchers