<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/NCT04459897</url>
  </required_header>
  <id_info>
    <org_study_id>LGH_2020</org_study_id>
    <nct_id>NCT04459897</nct_id>
  </id_info>
  <brief_title>Lyon Granulomatous Hepatitis Study</brief_title>
  <acronym>LGH</acronym>
  <official_title>Lyon Granulomatous Hepatitis Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Granulomatous hepatitis are histopathologically defined by the presence of epithelioid and&#xD;
      gigantocellular granulomas within the hepatic parenchyma. Hepatic granulomas are observed in&#xD;
      2 to 15% of liver biopsies. Causes of granulomatous hepatitis can be related to ethnic and&#xD;
      environmental factors and in western countries granulomatous hepatitis are mostly related to&#xD;
      sarcoidosis and autoimmune cholangitis. Infections (mycobacteria, coxiella burnetii,&#xD;
      hepatitis C) and medications also provide granulomatous hepatitis.&#xD;
&#xD;
      Sarcoidosis is a systemic disease of unknown etiology, which in third of cases has a chronic&#xD;
      course. Five percent of patients die of their disease, mainly because of respiratory&#xD;
      distress. Hepatic involvement is most often asymptomatic or pauci-symptomatic (moderate&#xD;
      cholestasis and conglomerates of granulomas visible on imaging). More rarely, it can cause&#xD;
      portal hypertension and its complications and be life-threatening.&#xD;
&#xD;
      The aim of the Lyon Hepatitis Granulomatous (LHG) study is to better characterize&#xD;
      granulomatous hepatitis and within these, severe hepatic sarcoidosis. This is a retrospective&#xD;
      study conducted from January 2008 to December 2016 proposed to all patients with&#xD;
      granulomatous hepatitis followed in the internal medicine and / or Hepato-gastroenterology&#xD;
      departments (Croix-Rousse Hospital, Edouard-Herriot Hospital, Lyon Sud Hospital Center). This&#xD;
      study will cover 596 patients who had a liver biopsy showing granulomas.&#xD;
&#xD;
      The main objectives of the Lyon Hepatitis Granulomatous (LHG) study are to analyze i) the&#xD;
      etiology of the disease and the contribution of molecular biology for infectious etiologies,&#xD;
      ii) the contribution of nuclear imaging for sarcoidosis diagnosis versus conventional&#xD;
      imaging, iii) treatment used and prognosis.&#xD;
&#xD;
      This study will permit a better characterization of granulomatous hepatitis, and liver&#xD;
      sarcoidosis in terms of prognosis as well as therapeutic management.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2023</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of epithelioid and gigantocellular granulomas within the hepatic parenchyma by histopathology approach.</measure>
    <time_frame>at inclusion visit</time_frame>
    <description>Retrospective histopathology review done by an expert of histopathology analysis (DAPI cell labeling). Analysis of the percentage of epithelioid cells and the percentage of gigantocellular granulomas in hepatic parenchyma of patient diagnosed for Hepatitis Granulomatous</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Patient Diagnosed or Treated for Granulomatous Hepatitis Followed in the Internal Medicine (and or) Hepato-gastroenterology Departments</condition>
  <arm_group>
    <arm_group_label>diagnosed or treated for granulomatous hepatitis fol</arm_group_label>
    <description>The cohort is composed by patient diagnosed or treated for granulomatous hepatitis followed in the internal medicine and / or Hepato-gastroenterology departments (Croix-Rousse Hospital, Edouard-Herriot Hospital, Lyon Sud Hospital Center).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation of epithelioid and gigantocellular granulomas within the hepatic parenchyma by histopathology approach.</intervention_name>
    <description>: Retrospective histopathology review done by an expert of histopathology analysis (DAPI cell labeling). Analysis of the percentage of epithelioid cells and the percentage of gigantocellular granulomas in hepatic parenchyma of patient diagnosed for Hepatitis Granulomatous</description>
    <arm_group_label>diagnosed or treated for granulomatous hepatitis fol</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patient diagnosed or treated for granulomatous hepatitis followed in the internal medicine&#xD;
        and / or Hepato-gastroenterology departments&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of granulomatous hepatitis&#xD;
&#xD;
          -  Patient followed in the internal medicine and / or Hepato-gastroenterology departments&#xD;
             (Croix-Rousse Hospital, Edouard-Herriot Hospital, Lyon Sud Hospital Center)&#xD;
&#xD;
          -  Collection of non-opposition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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_contact>
    <last_name>Pascal Sève</last_name>
    <phone>4 26 73 26 36</phone>
    <phone_ext>+33</phone_ext>
    <email>pascal.seve@chu-lyon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>: Hôpital de la Croix Rousse / GHN / service de médecine interne</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pascal Sève</last_name>
      <phone>4 26 73 26 36</phone>
      <phone_ext>+33</phone_ext>
      <email>pascal.seve@chu-lyon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Edouard Herriot / service de médecine interne</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arnaud Hot</last_name>
      <phone>4 72 11 75 65</phone>
      <phone_ext>+33</phone_ext>
      <email>arnaud.hot@chu-lyon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Lyon Sud / service de médecine interne</name>
      <address>
        <city>Pierre Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabelle First Name and Last Name : Isabelle Durieu</last_name>
      <phone>4 78 86 13 54</phone>
      <phone_ext>+33</phone_ext>
      <email>isabelle.durieu@chu-lyon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatitis Granulomatous</keyword>
  <keyword>liver sarcoidosis</keyword>
  <keyword>prognosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis</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/NCT04459897
org study id: LGH_2020
nct id: NCT04459897
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Granulomatous hepatitis are histopathologically defined by the presence of epithelioid and
      gigantocellular granulomas within the hepatic parenchyma. Hepatic granulomas are observed in
      2 to 15% of liver biopsies. Causes of granulomatous hepatitis can be related to ethnic and
      environmental factors and in western countries granulomatous hepatitis are mostly related to
      sarcoidosis and autoimmune cholangitis. Infections (mycobacteria, coxiella burnetii,
      hepatitis C) and medications also provide granulomatous hepatitis.

      Sarcoidosis is a systemic disease of unknown etiology, which in third of cases has a chronic
      course. Five percent of patients die of their disease, mainly because of respiratory
      distress. Hepatic involvement is most often asymptomatic or pauci-symptomatic (moderate
      cholestasis and conglomerates of granulomas visible on imaging). More rarely, it can cause
      portal hypertension and its complications and be life-threatening.

      The aim of the Lyon Hepatitis Granulomatous (LHG) study is to better characterize
      granulomatous hepatitis and within these, severe hepatic sarcoidosis. This is a retrospective
      study conducted from January 2008 to December 2016 proposed to all patients with
      granulomatous hepatitis followed in the internal medicine and / or Hepato-gastroenterology
      departments (Croix-Rousse Hospital, Edouard-Herriot Hospital, Lyon Sud Hospital Center). This
      study will cover 596 patients who had a liver biopsy showing granulomas.

      The main objectives of the Lyon Hepatitis Granulomatous (LHG) study are to analyze i) the
      etiology of the disease and the contribution of molecular biology for infectious etiologies,
      ii) the contribution of nuclear imaging for sarcoidosis diagnosis versus conventional
      imaging, iii) treatment used and prognosis.

      This study will permit a better characterization of granulomatous hepatitis, and liver
      sarcoidosis in terms of prognosis as well as therapeutic management.
observational model: Cohort
time perspective: Retrospective
measure: Evaluation of epithelioid and gigantocellular granulomas within the hepatic parenchyma by histopathology approach.
time frame: at inclusion visit
description: Retrospective histopathology review done by an expert of histopathology analysis (DAPI cell labeling). Analysis of the percentage of epithelioid cells and the percentage of gigantocellular granulomas in hepatic parenchyma of patient diagnosed for Hepatitis Granulomatous
arm group label: diagnosed or treated for granulomatous hepatitis fol
description: The cohort is composed by patient diagnosed or treated for granulomatous hepatitis followed in the internal medicine and / or Hepato-gastroenterology departments (Croix-Rousse Hospital, Edouard-Herriot Hospital, Lyon Sud Hospital Center).
intervention type: Other
intervention name: Evaluation of epithelioid and gigantocellular granulomas within the hepatic parenchyma by histopathology approach.
description: : Retrospective histopathology review done by an expert of histopathology analysis (DAPI cell labeling). Analysis of the percentage of epithelioid cells and the percentage of gigantocellular granulomas in hepatic parenchyma of patient diagnosed for Hepatitis Granulomatous
arm group label: diagnosed or treated for granulomatous hepatitis fol
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pascal Sève
phone: 4 26 73 26 36
phone ext: +33
email: pascal.seve@chu-lyon.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis