<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/NCT03267615</url>
  </required_header>
  <id_info>
    <org_study_id>VICIS</org_study_id>
    <nct_id>NCT03267615</nct_id>
  </id_info>
  <brief_title>VICIS - Vienna Cirrhosis Study</brief_title>
  <acronym>VICIS</acronym>
  <official_title>VICIS - Vienna Cirrhosis Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      Patients with advanced chronic liver diseases treated at the Vienna General Hospital of the&#xD;
      Medical University of Vienna will be offered to participate in this prospective observational&#xD;
      trial.&#xD;
&#xD;
      Clinical parameters and laboratory parameters will be recorded for all patients and patients&#xD;
      will undergo a regular follow-up schedule with clinical visits at the Vienna General&#xD;
      Hospital.&#xD;
&#xD;
      This study is linked to a biobank with serum/plasma, ascitic fluid, urine, GI tract mucosal&#xD;
      biopsies, liver biopsies and stool collected from the study participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with advanced chronic liver disease (ACLD) as evident by HVPG&gt;5mmHg or liver biopsy&#xD;
      showing F3/F4 fibrosis or as suggested by liver stiffness measurement (LSM) ≥10kPa can be&#xD;
      included in the VICIS study. In fact most patients will be recruited on the day of HVPG&#xD;
      measurement for screening for clinically significant portal hypertension (CSPH) or on the day&#xD;
      of upper GI endoscopy for screening for the presence of varices. Next to the detailled&#xD;
      characterization of patient characteristics by epidemiologic, clinical and laboratory&#xD;
      parameters, the degree of portal hypertension will be assessed by HVPG, liver stiffness will&#xD;
      be assessed by transient elastography, the presence of ascites, splenomegaly, portosystemic&#xD;
      collaterals, PVT and liver lesions will be assessed by ultrasound. In addition, the included&#xD;
      patients will be asked to participate in biobank sampling including serum/plasma, ascitic&#xD;
      fluid, urine, GI tract mucosal biopsies, stool, liver biopsies and stool. All patients&#xD;
      recruited in the VICIS study will be prospectively followed every 3 months (decompenated&#xD;
      ACLD) or every 6 months (compensated ACLD) patients with clinical visits at the Cirrhosis&#xD;
      Outpatient Clinic at the Vienna General Hospital. These assessments include the recording of&#xD;
      decompensating events (such as ascites, hepatic encephalopathy, variceal bleeding), screening&#xD;
      for PVT and HCC, and recording of medications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2026</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>10 Years</target_duration>
  <primary_outcome>
    <measure>Transplant-free survival</measure>
    <time_frame>01/FEB/2017 - 31/DECEMBER/2027</time_frame>
    <description>Time from inclusion to death or liver transplantation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decompensation-free survival</measure>
    <time_frame>01/FEB/2017 - 31/DECEMBER/2027</time_frame>
    <description>Time from inclusion to decompensation, death or liver transplantation</description>
  </secondary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Liver Cirrhosis</condition>
  <condition>Portal Hypertension</condition>
  <condition>Ascites</condition>
  <condition>Variceal Hemorrhage</condition>
  <condition>Hepatic Encephalopathy</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma, Serum, Urine, Stool, GI mucosa biopsies, ascitic fluid, liver tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with advanced chronic liver disease diagnosed and/or treated at the Medical&#xD;
        University of Vienna will be screened for inclusion/exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years and &lt;100 years&#xD;
&#xD;
          -  Diagnosis of advanced chronic liver disease (by liver stiffness ≥10kPa, HVPG&gt;5mmHg or&#xD;
             Histology F3/F4)&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Withdrawal of written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Reiberger, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas Reiberger, M.D.</last_name>
    <phone>+43140400</phone>
    <phone_ext>65890</phone_ext>
    <email>thomas.reiberger@meduniwien.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mattias Mandorer, M.D.</last_name>
    <phone>+43140400</phone>
    <phone_ext>47410</phone_ext>
    <email>mattias.mandorfer@meduniwien.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Reiberger, M.D.</last_name>
      <phone>+43140400</phone>
      <phone_ext>47440</phone_ext>
      <email>thomas.reiberger@meduniwien.ac.at</email>
    </contact>
    <contact_backup>
      <last_name>Alexandra Weisgram</last_name>
      <phone>+43140400</phone>
      <phone_ext>47410</phone_ext>
      <email>alexandra.weisgram@meduniwien.ac.at</email>
    </contact_backup>
    <investigator>
      <last_name>Mattias Mandorfer, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Philipp Schwabl, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bernhard Scheiner, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thomas Reiberger, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>October 9, 2022</last_update_submitted>
  <last_update_submitted_qc>October 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Thomas Reiberger</investigator_full_name>
    <investigator_title>Assoc.Prof.Priv.Doz.Dr.</investigator_title>
  </responsible_party>
  <keyword>Liver Cirrhosis</keyword>
  <keyword>Portal Hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Hypertension, Portal</mesh_term>
    <mesh_term>Hepatic Encephalopathy</mesh_term>
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
    <mesh_term>Ascites</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03267615
org study id: VICIS
nct id: NCT03267615
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with advanced chronic liver diseases treated at the Vienna General Hospital of the
      Medical University of Vienna will be offered to participate in this prospective observational
      trial.

      Clinical parameters and laboratory parameters will be recorded for all patients and patients
      will undergo a regular follow-up schedule with clinical visits at the Vienna General
      Hospital.

      This study is linked to a biobank with serum/plasma, ascitic fluid, urine, GI tract mucosal
      biopsies, liver biopsies and stool collected from the study participants.
Patients with advanced chronic liver disease (ACLD) as evident by HVPG>5mmHg or liver biopsy
      showing F3/F4 fibrosis or as suggested by liver stiffness measurement (LSM) ≥10kPa can be
      included in the VICIS study. In fact most patients will be recruited on the day of HVPG
      measurement for screening for clinically significant portal hypertension (CSPH) or on the day
      of upper GI endoscopy for screening for the presence of varices. Next to the detailled
      characterization of patient characteristics by epidemiologic, clinical and laboratory
      parameters, the degree of portal hypertension will be assessed by HVPG, liver stiffness will
      be assessed by transient elastography, the presence of ascites, splenomegaly, portosystemic
      collaterals, PVT and liver lesions will be assessed by ultrasound. In addition, the included
      patients will be asked to participate in biobank sampling including serum/plasma, ascitic
      fluid, urine, GI tract mucosal biopsies, stool, liver biopsies and stool. All patients
      recruited in the VICIS study will be prospectively followed every 3 months (decompenated
      ACLD) or every 6 months (compensated ACLD) patients with clinical visits at the Cirrhosis
      Outpatient Clinic at the Vienna General Hospital. These assessments include the recording of
      decompensating events (such as ascites, hepatic encephalopathy, variceal bleeding), screening
      for PVT and HCC, and recording of medications.
observational model: Cohort
time perspective: Prospective
measure: Transplant-free survival
time frame: 01/FEB/2017 - 31/DECEMBER/2027
description: Time from inclusion to death or liver transplantation
measure: Decompensation-free survival
time frame: 01/FEB/2017 - 31/DECEMBER/2027
description: Time from inclusion to decompensation, death or liver transplantation
Plasma, Serum, Urine, Stool, GI mucosa biopsies, ascitic fluid, liver tissue
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Thomas Reiberger, M.D.
role: Principal Investigator
affiliation: Medical University of Vienna
last name: Thomas Reiberger, M.D.
phone: +43140400
phone ext: 65890
email: thomas.reiberger@meduniwien.ac.at
last name: Mattias Mandorer, M.D.
phone: +43140400
phone ext: 47410
email: mattias.mandorfer@meduniwien.ac.at
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Thomas Reiberger
investigator title: Assoc.Prof.Priv.Doz.Dr.
mesh term: Liver Cirrhosis
mesh term: Hypertension, Portal
mesh term: Hepatic Encephalopathy
mesh term: Brain Diseases
mesh term: Hypertension
mesh term: Hemorrhage
mesh term: Fibrosis
mesh term: Ascites
sharing ipd: No