<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/NCT03789825</url>
  </required_header>
  <id_info>
    <org_study_id>LiverScreen</org_study_id>
    <nct_id>NCT03789825</nct_id>
  </id_info>
  <brief_title>Population-based Study in Screening for Liver Fibrosis</brief_title>
  <acronym>LiverScreen</acronym>
  <official_title>Screening for Liver Fibrosis. A Population-based Study in European Countries. The ''LiverScreen'' Project.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Judit Pich Martínez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacion Clinic per a la Recerca Biomédica</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>
      Study to assess the prevalence of significant liver fibrosis in general population using&#xD;
      Transient Elastography&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a population-based study. Subjects will attend a primary care center where a physical&#xD;
      examination, general blood test and transient elastography will be carried out. Only the&#xD;
      group of patients with high-risk for liver fibrosis will be evaluated in a second visit at&#xD;
      the University Hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">May 1, 2018</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>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>% of subjects with Liver stiffness measurement by Transient Elastography &gt;=8 Kpa at any visit</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Percentage of subjects with Liver stiffness measurement by Transient Elastography ≥ 8Kpa at any visit, either with M or XL probe, in general population.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>% of subjects with Liver stiffness measurement by Transient Elastography &gt;=8 Kpa in the subgroup of patients with risk factors for chronic liver disease at visit 1 or 2</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Percentage of subjects with Liver stiffness measurement by Transient Elastography ≥ 8Kpa, either with M or XL probe, in the subgroup of patients with risk factors for chronic liver disease at visit 1 and/or 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of liver fibrosis diagnosis accuracy between Transient Elastography and fibrosis scores</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Comparison of liver fibrosis diagnosis accuracy between Transient Elastography and fibrosis scores (including NAFLD fibrosis score, FIB-4, Forms index and APRI score) for the diagnosis of liver fibrosis in general population and in the subgroup of patients with risk factors for chronic liver disease at visit 1 and 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of liver fibrosis diagnosis accuracy between Transient Elastography, fibrosis scores and liver biopsy</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Comparison of liver fibrosis diagnosis accuracy between Transient Elastography, fibrosis scores and liver biopsy for the diagnosis of liver fibrosis in general population and in the subgroup of patients with risk factors for chronic liver disease, in patients with liver biopsy available at visit 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of subjects with CAP ≥250 dB/m2</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Percentage of subjects with CAP ≥250 dB/m2, either with M or XL probe, in general population and in the subgroup of patients with risk factors for chronic liver disease at visit 1 and/or 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of liver steatosis diagnosis accuracy between CAP and steatosis scores</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Comparison of liver steatosis diagnosis accuracy between CAP and steatosis scores (including FLI, HIS, LAP, ION and NAFLD-LFS) for the diagnosis of liver steatosis in general population and in the subgroup of patients with risk factors for chronic liver disease at visit 1 and 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of liver steatosis diagnosis accuracy between CAP, steatosis scores and liver biopsy</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Comparison of liver steatosis diagnosis accuracy between CAP, steatosis scores (including FLI, HIS, LAP, ION and NAFLD-LFS) and liver biopsy for the diagnosis of liver steatosis in general population and in the subgroup of patients with risk factors for chronic liver disease, in patients with liver biopsy available (at visit 2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of liver steatosis diagnosis accuracy between CAP and abdominal ultrasound</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Comparison of liver steatosis diagnosis accuracy between CAP and abdominal ultrasound for the diagnosis of liver steatosis in general population and in the subgroup of patients with risk factors for chronic liver disease, in patients with abdominal ultrasound available at visit 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of values obtained with M and XL probes in the assessment of LSM and CAP via TE</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Comparison of values obtained with M and XL probes in the assessment of LSM and CAP via TE at visit 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness of a liver fibrosis screening program for liver fibrosis detection in general population</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Cost-effectiveness of a liver fibrosis screening program for liver fibrosis detection in general population and in the subgroup of patients with risk factors for chronic liver disease. Direct and indirect cost savings of early detection of liver fibrosis in subjects with risk factors for chronic liver diseases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of failure rate for stiffness and steatosis measurements within TE examination</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Percentage of failure rate for stiffness and steatosis measurements within TE examination at visit 1 and 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with procedure related adverse events and serious adverse events</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Percentage of patients with procedure related adverse events (adverse events related to TE and liver biopsy) and serious adverse events during all the duration of the study.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20000</enrollment>
  <condition>Liver Diseases</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma and serum specimens will be retained in a repository&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        General population above 40 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 40 years&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously known chronic liver disease (including cholestasis). Patients with already&#xD;
             known liver steatosis but no diagnosis of liver fibrosis or cirrhosis can be included&#xD;
&#xD;
          -  Subjects with mental incapacity, language barrier, insufficient social support or any&#xD;
             other reason considered by the investigator precluding adequate understanding or&#xD;
             cooperation in the study&#xD;
&#xD;
          -  Subjects with a history of current malignancy including solid tumors and hematologic&#xD;
             disorders&#xD;
&#xD;
          -  Subjects with significant extrahepatic disease that may impair short-term prognosis&#xD;
             (including congestive heart failure New York Heart Association Grade IV, COPD GOLD &gt;3)&#xD;
&#xD;
          -  Subjects with kidney disease (serum creatinine &gt;3mg/dL or under renal replacement&#xD;
             therapy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pere Ginès, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Fundacion Clinic per a la Recerca Biomédica</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dubrava Hospital</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poliklinika Croatia</name>
      <address>
        <city>Zagreb</city>
        <zip>1000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de santé Municipal Etienne Gatineau-Sailliant de Genevilliers</name>
      <address>
        <city>Gennevilliers</city>
        <zip>92230</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Recherche Clinique - CRC</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Avicenne</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Beaujon</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Homburg Hospital</name>
      <address>
        <city>Homburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mainz Hospital</name>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MVZ Dres.Schneider Kaiserslautern</name>
      <address>
        <city>Rodenbach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Rotterdam</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SEAT</name>
      <address>
        <city>Martorell</city>
        <state>Barcelona</state>
        <zip>08760</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP II El Maresme</name>
      <address>
        <city>Mataró</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP II Santa Coloma de Gramanet</name>
      <address>
        <city>Santa Coloma De Gramenet</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP La Florida</name>
      <address>
        <city>Santa Perpètua De Mogoda</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP Barceloneta</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP Bordeta-Magòria</name>
      <address>
        <city>Barcelona</city>
        <zip>08014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP Río de Janeiro</name>
      <address>
        <city>Barcelona</city>
        <zip>08016</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP Ciutat Meridiana</name>
      <address>
        <city>Barcelona</city>
        <zip>08033</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP Sant Rafael</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universirati Vall d'Hebrón</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP Adrià</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP La Marina</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP Numància</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oak Lodge Medical Centre</name>
      <address>
        <city>Edgware</city>
        <zip>HA8 0AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Andrews Medical Practice</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospital</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's Mill Hospital</name>
      <address>
        <city>Sutton In Ashfield</city>
        <zip>NG17 4JL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>September 15, 2022</last_update_submitted>
  <last_update_submitted_qc>September 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fundacion Clinic per a la Recerca Biomédica</investigator_affiliation>
    <investigator_full_name>Judit Pich Martínez</investigator_full_name>
    <investigator_title>Clinical Research Manager</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Liver Cirrhosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03789825
org study id: LiverScreen
nct id: NCT03789825
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study to assess the prevalence of significant liver fibrosis in general population using
      Transient Elastography
This is a population-based study. Subjects will attend a primary care center where a physical
      examination, general blood test and transient elastography will be carried out. Only the
      group of patients with high-risk for liver fibrosis will be evaluated in a second visit at
      the University Hospital.
observational model: Other
time perspective: Prospective
measure: % of subjects with Liver stiffness measurement by Transient Elastography >=8 Kpa at any visit
time frame: Through study completion, an average of 24 months
description: Percentage of subjects with Liver stiffness measurement by Transient Elastography ≥ 8Kpa at any visit, either with M or XL probe, in general population.
measure: % of subjects with Liver stiffness measurement by Transient Elastography >=8 Kpa in the subgroup of patients with risk factors for chronic liver disease at visit 1 or 2
time frame: Through study completion, an average of 24 months
description: Percentage of subjects with Liver stiffness measurement by Transient Elastography ≥ 8Kpa, either with M or XL probe, in the subgroup of patients with risk factors for chronic liver disease at visit 1 and/or 2.
measure: Comparison of liver fibrosis diagnosis accuracy between Transient Elastography and fibrosis scores
time frame: Through study completion, an average of 24 months
description: Comparison of liver fibrosis diagnosis accuracy between Transient Elastography and fibrosis scores (including NAFLD fibrosis score, FIB-4, Forms index and APRI score) for the diagnosis of liver fibrosis in general population and in the subgroup of patients with risk factors for chronic liver disease at visit 1 and 2.
measure: Comparison of liver fibrosis diagnosis accuracy between Transient Elastography, fibrosis scores and liver biopsy
time frame: Through study completion, an average of 24 months
description: Comparison of liver fibrosis diagnosis accuracy between Transient Elastography, fibrosis scores and liver biopsy for the diagnosis of liver fibrosis in general population and in the subgroup of patients with risk factors for chronic liver disease, in patients with liver biopsy available at visit 2.
measure: % of subjects with CAP ≥250 dB/m2
time frame: Through study completion, an average of 24 months
description: Percentage of subjects with CAP ≥250 dB/m2, either with M or XL probe, in general population and in the subgroup of patients with risk factors for chronic liver disease at visit 1 and/or 2
measure: Comparison of liver steatosis diagnosis accuracy between CAP and steatosis scores
time frame: Through study completion, an average of 24 months
description: Comparison of liver steatosis diagnosis accuracy between CAP and steatosis scores (including FLI, HIS, LAP, ION and NAFLD-LFS) for the diagnosis of liver steatosis in general population and in the subgroup of patients with risk factors for chronic liver disease at visit 1 and 2.
measure: Comparison of liver steatosis diagnosis accuracy between CAP, steatosis scores and liver biopsy
time frame: Through study completion, an average of 24 months
description: Comparison of liver steatosis diagnosis accuracy between CAP, steatosis scores (including FLI, HIS, LAP, ION and NAFLD-LFS) and liver biopsy for the diagnosis of liver steatosis in general population and in the subgroup of patients with risk factors for chronic liver disease, in patients with liver biopsy available (at visit 2).
measure: Comparison of liver steatosis diagnosis accuracy between CAP and abdominal ultrasound
time frame: Through study completion, an average of 24 months
description: Comparison of liver steatosis diagnosis accuracy between CAP and abdominal ultrasound for the diagnosis of liver steatosis in general population and in the subgroup of patients with risk factors for chronic liver disease, in patients with abdominal ultrasound available at visit 2.
measure: Comparison of values obtained with M and XL probes in the assessment of LSM and CAP via TE
time frame: Through study completion, an average of 24 months
description: Comparison of values obtained with M and XL probes in the assessment of LSM and CAP via TE at visit 2.
measure: Cost-effectiveness of a liver fibrosis screening program for liver fibrosis detection in general population
time frame: Through study completion, an average of 24 months
description: Cost-effectiveness of a liver fibrosis screening program for liver fibrosis detection in general population and in the subgroup of patients with risk factors for chronic liver disease. Direct and indirect cost savings of early detection of liver fibrosis in subjects with risk factors for chronic liver diseases.
measure: Percentage of failure rate for stiffness and steatosis measurements within TE examination
time frame: Through study completion, an average of 24 months
description: Percentage of failure rate for stiffness and steatosis measurements within TE examination at visit 1 and 2.
measure: Percentage of patients with procedure related adverse events and serious adverse events
time frame: Through study completion, an average of 24 months
description: Percentage of patients with procedure related adverse events (adverse events related to TE and liver biopsy) and serious adverse events during all the duration of the study.
Plasma and serum specimens will be retained in a repository
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pere Ginès, MD
role: Study Chair
affiliation: Fundacion Clinic per a la Recerca Biomédica
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country: Croatia
country: Denmark
country: France
country: Germany
country: Netherlands
country: Spain
country: United Kingdom
responsible party type: Sponsor-Investigator
investigator affiliation: Fundacion Clinic per a la Recerca Biomédica
investigator full name: Judit Pich Martínez
investigator title: Clinical Research Manager
mesh term: Liver Diseases
mesh term: Liver Cirrhosis