<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/NCT02983968</url>
  </required_header>
  <id_info>
    <org_study_id>RNI2015-43 Pr Ganry</org_study_id>
    <nct_id>NCT02983968</nct_id>
  </id_info>
  <brief_title>Use of the French Healthcare Insurance Database</brief_title>
  <acronym>SAMHEPAT</acronym>
  <official_title>Use of the French Healthcare Insurance Database to Evaluate How Early Diagnosis of Hepatocellular Carcinomas is Implemented in France: SAMHEPAT Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</source>
  <brief_summary>
    <textblock>
      Hepatocellular carcinoma (HCC) has become the second most common cause of cancer death in the&#xD;
      world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatocellular carcinoma (HCC) has become the second most common cause of cancer death in the&#xD;
      world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths).&#xD;
      This cancer is closely associated with the presence of chronic liver underlying disease and&#xD;
      early diagnosis following a systematic surveillance of cirrhotic patients could improve&#xD;
      disease-free survival in patients declaring HCC. However, the risk-benefit ratio of such&#xD;
      monitoring is discussed. Nevertheless, it is recommended in patients with liver cirrhosis,&#xD;
      from which the prevalence is estimated between 0.3% and 0.6% in the French population. This&#xD;
      debate can lead to a failure to comply with recommendations and promote a large variability&#xD;
      in the management of the surveillance of HCC in patients with cirrhosis in practice. Data&#xD;
      acquisition regarding the current situation in France is required.&#xD;
&#xD;
      The objective of this project is to use this database to document current practices&#xD;
      concerning monitoring of incidents HCC in cirrhotic patients in France. A retrospective&#xD;
      cohort study will be conducted on data from SNIIRAM recorded between 2007 and 2015. The&#xD;
      primary analysis will focus on multivariate modelling of the deviation rate from the&#xD;
      recommendations (advising the realisation of at least two echodoppler ultrasonographies&#xD;
      yearly) with a competitive risk model, taking into account gender, social status, Charlson&#xD;
      index, age at baseline, the alcoholic etiology of cirrhosis, type of facility and the yearly&#xD;
      number of visits to a hepatologist during follow-up. It is estimated that more than 86,000&#xD;
      patients with a minimum follow-up of 3 years will be included in the analysis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</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>Rate of deviation from the guidelines</measure>
    <time_frame>01/01/2007 - 01/01/2018</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Factors associated with deviation from the guidelines</measure>
    <time_frame>01/01/2007 - 01/01/2018</time_frame>
    <description>A multivariate regression analysis will be performed to objectivate factors associated with the deviation among sex, poor social status, Charlson index, age at inclusion and the alcoholic aetiology of the cirrhosis, type facility where hospitalisation occurred, number of hepatologist visits and living area</description>
  </secondary_outcome>
  <enrollment type="Anticipated">890</enrollment>
  <condition>Cirrhosis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Description of the cirrhosis management</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cirrhotic patients aged between 18 and 75 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Cirrhotic patients aged between 18 and 75 years.&#xD;
&#xD;
        (A cirrhotic patient will be defined as a presenting a first occurrence of a codes used in&#xD;
        hospitalisation for cirrhosis or as a motive for granting an ALD 6 (cirrhosis motivated)&#xD;
        financial support )&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olivier GANRY, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Amiens</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Olivier GANRY, MD, PhD</last_name>
    <phone>+33 3 66 81 93</phone>
    <email>ganry.olivier@chu-amiens.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80084</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier GANRY, MD, PhD</last_name>
      <phone>+33 3 66 81 93</phone>
      <email>ganry.olivier@chu-amiens.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>August 3, 2018</last_update_submitted>
  <last_update_submitted_qc>August 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oncology</keyword>
  <keyword>Hepatology</keyword>
  <keyword>Public Health</keyword>
  <keyword>Liver</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrosis</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/NCT02983968
org study id: RNI2015-43 Pr Ganry
nct id: NCT02983968
lead sponsor: 
Hepatocellular carcinoma (HCC) has become the second most common cause of cancer death in the
      world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths).
Hepatocellular carcinoma (HCC) has become the second most common cause of cancer death in the
      world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths).
      This cancer is closely associated with the presence of chronic liver underlying disease and
      early diagnosis following a systematic surveillance of cirrhotic patients could improve
      disease-free survival in patients declaring HCC. However, the risk-benefit ratio of such
      monitoring is discussed. Nevertheless, it is recommended in patients with liver cirrhosis,
      from which the prevalence is estimated between 0.3% and 0.6% in the French population. This
      debate can lead to a failure to comply with recommendations and promote a large variability
      in the management of the surveillance of HCC in patients with cirrhosis in practice. Data
      acquisition regarding the current situation in France is required.

      The objective of this project is to use this database to document current practices
      concerning monitoring of incidents HCC in cirrhotic patients in France. A retrospective
      cohort study will be conducted on data from SNIIRAM recorded between 2007 and 2015. The
      primary analysis will focus on multivariate modelling of the deviation rate from the
      recommendations (advising the realisation of at least two echodoppler ultrasonographies
      yearly) with a competitive risk model, taking into account gender, social status, Charlson
      index, age at baseline, the alcoholic etiology of cirrhosis, type of facility and the yearly
      number of visits to a hepatologist during follow-up. It is estimated that more than 86,000
      patients with a minimum follow-up of 3 years will be included in the analysis
observational model: Cohort
time perspective: Retrospective
measure: Rate of deviation from the guidelines
time frame: 01/01/2007 - 01/01/2018
measure: Factors associated with deviation from the guidelines
time frame: 01/01/2007 - 01/01/2018
description: A multivariate regression analysis will be performed to objectivate factors associated with the deviation among sex, poor social status, Charlson index, age at inclusion and the alcoholic aetiology of the cirrhosis, type facility where hospitalisation occurred, number of hepatologist visits and living area
intervention type: Other
intervention name: Description of the cirrhosis management
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Olivier GANRY, MD, PhD
role: Principal Investigator
affiliation: CHU Amiens
last name: Olivier GANRY, MD, PhD
phone: +33 3 66 81 93
email: ganry.olivier@chu-amiens.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Fibrosis