<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/NCT03307408</url>
  </required_header>
  <id_info>
    <org_study_id>16-AOI-12</org_study_id>
    <nct_id>NCT03307408</nct_id>
  </id_info>
  <brief_title>Hepatocellular Carcinoma in Patients With a Cirrhosis Due to an Alcoholic or a Non Alcoholic Fatty Liver Disease</brief_title>
  <acronym>CHALNA</acronym>
  <official_title>Hepatocellular Carcinoma in Patients With a Cirrhosis Due to an Alcoholic or a Non Alcoholic Fatty Liver Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</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>
      Global prevalence of Non Alcoholic Fatty Liver Diseases (NAFLD) ranges from 22% to 28%.The&#xD;
      spectrum of these hepatic abnormalities extends from isolated steatosis to steatohepatitis&#xD;
      (Non Alcoholic Steato-Hepatitis, NASH) and steatofibrosis leading to cirrhosis and&#xD;
      hepatocellular carcinoma. NAFLD is one of the main causes of cirrhosis and increases the risk&#xD;
      of liver-related death and hepatocellular carcinoma (developed in patients with or without&#xD;
      cirrhosis). Despite this major public health concern, apart from lifestyle changes, treatment&#xD;
      of NAFLD is still elusive as there is lack of efficacious pharmacological treatment.&#xD;
      Alcoholic liver diseases are also frequent in Western countries. Alcoholic liver diseases and&#xD;
      NAFLD share common pathological lesions and molecular pathways. This is illustrated by the&#xD;
      emerging role of abnormalities of the microbiota (dysbiosis) in these 2 diseases leading to&#xD;
      the concept of &quot; liver-gut axis &quot;. Whereas the molecular mechanisms responsible for the&#xD;
      progression from a &quot;safety&quot; state to NASH or to a severe alcoholic steato-hepatitis are still&#xD;
      unclear, hepatic inflammation is a key factor involved in the progression of NAFLD and&#xD;
      alcoholic liver disease.&#xD;
&#xD;
      The hypothesis is that cellular and molecular abnormalities and gut dysbiosis could be&#xD;
      present in patients with simple steatosis or with steato-hepatitis and could be responsible&#xD;
      for the occurrence of hepatocellular carcinoma particularly without cirrhosis.&#xD;
&#xD;
      The main objective is to compare cellular and inflammatory pathways in liver with and without&#xD;
      hepatocellular carcinoma in patients with alcoholic or non-alcoholic fatty liver diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 28, 2017</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">February 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dosage of immunity cells in liver</measure>
    <time_frame>8 weeks</time_frame>
    <description>The investigators determine the stage of liver by biochemical, genetic (and immunocytochemistry methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dosage of the inflammatory cells in liver</measure>
    <time_frame>8 weeks</time_frame>
    <description>The investigators determine the stage of liver by biochemical, genetic and immunocytochemistry methods.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dosage of the glucose</measure>
    <time_frame>8 weeks</time_frame>
    <description>The investigators determine the genes implicated in oxidative stress, reticulum endoplasmic stress and autophagy .</description>
  </secondary_outcome>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood collection</intervention_name>
    <description>Standard routine practice clinico-biological data will be collected</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples, tissu samples, feces samples,&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with alcoholic or non-alcoholic fatty liver diseases.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Group 1&#xD;
&#xD;
        Inclusion Criteria :&#xD;
&#xD;
          -  Available social insurance&#xD;
&#xD;
          -  Signed consent for the study enrollment&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria :&#xD;
&#xD;
          -  Patients in the group with metabolic fatty liver with hepatocellular carcinoma&#xD;
&#xD;
          -  Alcohol consumption ≤ 30 g/d (or 210 g/week) in men and ≤ 20 g/d (or 140 g/week) in&#xD;
             women.&#xD;
&#xD;
          -  Decision (less than 3 months) to perform a liver biopsy of a tumor suspect of HCC and&#xD;
             of adjacent liver in routine practice.&#xD;
&#xD;
          -  No systemic HCC treatment in the previous 6 months&#xD;
&#xD;
        Group 2&#xD;
&#xD;
        Inclusion Criteria :&#xD;
&#xD;
          -  Available social insurance&#xD;
&#xD;
          -  Signed consent for the study enrollment&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria :&#xD;
&#xD;
          -  Patients in the group with metabolic fatty liver without hepatocellular carcinoma&#xD;
&#xD;
          -  Alcohol consumption ≤ 30 g/d (or 210 g/week) in men and ≤ 20 g/d (or 140 g/week) in&#xD;
             women.&#xD;
&#xD;
          -  Decision (less than 3 months) to perform a liver biopsy in routine practice. Liver&#xD;
             biopsy will be organized because of one or more liver abnormalities and/or fatty liver&#xD;
             seen at liver ultrasound due to the current lack of validated non-invasive marker of&#xD;
             inflammation, cellular death and fibrosis in these patients.&#xD;
&#xD;
        Group 3&#xD;
&#xD;
        Inclusion Criteria :&#xD;
&#xD;
          -  Available social insurance&#xD;
&#xD;
          -  Signed consent for the study enrollment&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria :&#xD;
&#xD;
          -  Patients with an alcoholic liver disease with hepatocellular carcinoma&#xD;
&#xD;
          -  Alcohol consumption &gt; 30 g/d (or 210 g/week) in men and &gt; 20 g/d (or 140 g/week) in&#xD;
             women.&#xD;
&#xD;
          -  Decision (less than 3 months) to perform a liver biopsy of a tumor suspect of HCC and&#xD;
             of adjacent liver in routine practice.&#xD;
&#xD;
          -  No systemic HCC treatment in the previous 6 months&#xD;
&#xD;
        Group 4&#xD;
&#xD;
        Inclusion Criteria :&#xD;
&#xD;
          -  Available social insurance&#xD;
&#xD;
          -  Signed consent for the study enrollment&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria :&#xD;
&#xD;
          -  Patients with an alcoholic liver disease without hepatocellular carcinoma&#xD;
&#xD;
          -  Alcohol consumption &gt; 30 g/d (or 210 g/week) in men and &gt; 20 g/d (or 140 g/week) in&#xD;
             women.&#xD;
&#xD;
          -  Decision (less than 3 months) to perform a liver biopsy in routine practice. No&#xD;
             systemic HCC treatment in the previous 6 months. Liver biopsy will be organized&#xD;
             because of one or more liver abnormalities and/or fatty liver seen at liver ultrasound&#xD;
             due to the current lack of validated non-invasive marker of inflammation, cellular&#xD;
             death and fibrosis in these patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Rodolphe ANTY, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Nice</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sylvie MALERBA</last_name>
    <phone>+33492034011</phone>
    <email>drc@chu-nice.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sylvie MALERBA</last_name>
      <phone>+33492034011</phone>
      <email>drc@chu-nice.fr</email>
    </contact>
    <investigator>
      <last_name>Rodolphe ANTY, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</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/NCT03307408
org study id: 16-AOI-12
nct id: NCT03307408
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Global prevalence of Non Alcoholic Fatty Liver Diseases (NAFLD) ranges from 22% to 28%.The
      spectrum of these hepatic abnormalities extends from isolated steatosis to steatohepatitis
      (Non Alcoholic Steato-Hepatitis, NASH) and steatofibrosis leading to cirrhosis and
      hepatocellular carcinoma. NAFLD is one of the main causes of cirrhosis and increases the risk
      of liver-related death and hepatocellular carcinoma (developed in patients with or without
      cirrhosis). Despite this major public health concern, apart from lifestyle changes, treatment
      of NAFLD is still elusive as there is lack of efficacious pharmacological treatment.
      Alcoholic liver diseases are also frequent in Western countries. Alcoholic liver diseases and
      NAFLD share common pathological lesions and molecular pathways. This is illustrated by the
      emerging role of abnormalities of the microbiota (dysbiosis) in these 2 diseases leading to
      the concept of " liver-gut axis ". Whereas the molecular mechanisms responsible for the
      progression from a "safety" state to NASH or to a severe alcoholic steato-hepatitis are still
      unclear, hepatic inflammation is a key factor involved in the progression of NAFLD and
      alcoholic liver disease.

      The hypothesis is that cellular and molecular abnormalities and gut dysbiosis could be
      present in patients with simple steatosis or with steato-hepatitis and could be responsible
      for the occurrence of hepatocellular carcinoma particularly without cirrhosis.

      The main objective is to compare cellular and inflammatory pathways in liver with and without
      hepatocellular carcinoma in patients with alcoholic or non-alcoholic fatty liver diseases.
observational model: Cohort
time perspective: Prospective
measure: Dosage of immunity cells in liver
time frame: 8 weeks
description: The investigators determine the stage of liver by biochemical, genetic (and immunocytochemistry methods.
measure: Dosage of the inflammatory cells in liver
time frame: 8 weeks
description: The investigators determine the stage of liver by biochemical, genetic and immunocytochemistry methods.
measure: Dosage of the glucose
time frame: 8 weeks
description: The investigators determine the genes implicated in oxidative stress, reticulum endoplasmic stress and autophagy .
intervention type: Other
intervention name: blood collection
description: Standard routine practice clinico-biological data will be collected
blood samples, tissu samples, feces samples,
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Rodolphe ANTY, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Nice
last name: Sylvie MALERBA
phone: +33492034011
email: drc@chu-nice.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: No