<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/NCT04405024</url>
  </required_header>
  <id_info>
    <org_study_id>HOSPI-VHC</org_study_id>
    <secondary_id>2019-A03309-48</secondary_id>
    <nct_id>NCT04405024</nct_id>
  </id_info>
  <brief_title>Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients</brief_title>
  <acronym>HOSPI-VHC</acronym>
  <official_title>Pilot Study of the Feasibility of Routine Inpatient Hepatitis C Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Intercommunal Creteil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Intercommunal Creteil</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>
      The Ministry of Health has set the target of eradicating hepatitis C (HCV) in France by 2025.&#xD;
&#xD;
      The goal is to validate the feasibility and value of conducting routine HCV screening in&#xD;
      hospitalized patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The number of undetected HCV-infected persons has been extrapolated to 75,000 according to&#xD;
      the results of a 2014 study. Screening efforts have been set up in groups of people said to&#xD;
      be at high viral risk: drug users, prisoners, precarious persons or migrants from highly&#xD;
      endemic countries. Nevertheless, the concept of universal screening has not yet been adopted&#xD;
      by the guardians and the Ministry.&#xD;
&#xD;
      It is in this context that &quot;hepatitis free hospital&quot; projects have been carried out in&#xD;
      several French cities such as Nice, Nancy and Marseille.&#xD;
&#xD;
      The aim of the HOSPI-VHC study is to evaluate the feasibility and efficiency of systematic&#xD;
      HCV screening in all medical and surgical departments of 4 National Association of&#xD;
      Hepato-Gastroenterologists of General Hospitals (ANGH) hospitals. This pilot project is part&#xD;
      of a public health screening program. It will evaluate the interest and usefulness of&#xD;
      implementing universal screening in hospitalized patients without taking into account the&#xD;
      existence of viral risk factors. This study will also make it possible to evaluate the&#xD;
      implementation of a dedicated care pathway: number of patients screened, number of patients&#xD;
      referred for consultation and number of patients accepting the consultation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Anticipated">August 21, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 21, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>potential patient versus</measure>
    <time_frame>7 days</time_frame>
    <description>Number of HCV serologies collected compared to the number of patients meeting the inclusion criteria during the study period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HCV positive</measure>
    <time_frame>7 days</time_frame>
    <description>Percentage positive for HCV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up</measure>
    <time_frame>2 months</time_frame>
    <description>Percentage of patients referred for consultation if HCV positive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Polymerase chain reaction (PCR)</measure>
    <time_frame>7 days</time_frame>
    <description>Percentage of HCV PCR positive patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral risk factor</measure>
    <time_frame>7 days</time_frame>
    <description>Percentage of patients with a viral risk factor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hepatic fibrosis</measure>
    <time_frame>7 days</time_frame>
    <description>Percentage of patients with hepatic fibrosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>treatment initiation</measure>
    <time_frame>2 months</time_frame>
    <description>Percentage of patients benefiting from treatment initiation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Hepatitis C testing</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>If the patient is included in the study, HCV serology (2 x 5 ml tubes) will be taken at the time of admission as part of the routine entry assessment.&#xD;
These two tubes will be used for HCV screening. The patient is informed of the HCV serology result during hospitalization by an investigator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Hepatitis C testing</intervention_name>
    <description>Hepatitis C Screening</description>
    <arm_group_label>Hepatitis C testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 18 years of age&#xD;
&#xD;
          -  Hospitalized during the study period&#xD;
&#xD;
          -  Non-opposition for participation in the Protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years of age&#xD;
&#xD;
          -  Outpatient, long-stay, maternity and intensive care inpatients&#xD;
&#xD;
          -  Patients refusing blood collection&#xD;
&#xD;
          -  Patient may not understand the information sheet&#xD;
&#xD;
          -  Patient under guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Isabelle Rosa, PhD</last_name>
    <phone>01 45 17 50 00</phone>
    <phone_ext>+33</phone_ext>
    <email>isabelle.rosa@chicreteil.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Camille JUNG</last_name>
    <phone>01 45 17 50 00</phone>
    <phone_ext>+33</phone_ext>
    <email>camille.jung@chicreteil.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHI Créteil</name>
      <address>
        <city>Créteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabelle Rosa</last_name>
      <email>isabelle.rosa@chicreteil.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Grand Hôpital de l'Est Francilien - Site de Marne-la-Vallée</name>
      <address>
        <city>Jossigny</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gilles MACAIGNE</last_name>
      <email>gmacaigne@ghef.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Meaux</name>
      <address>
        <city>Meaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hatem SALLOUM</last_name>
      <email>hatemsalloum@yahoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHIV</name>
      <address>
        <city>Villeneuve-Saint-Georges</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Armand GARIOUD</last_name>
      <email>Armand.Garioud@chiv.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>June 7, 2023</last_update_submitted>
  <last_update_submitted_qc>June 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2023</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>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</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/NCT04405024
org study id: HOSPI-VHC
secondary id: 2019-A03309-48
nct id: NCT04405024
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Ministry of Health has set the target of eradicating hepatitis C (HCV) in France by 2025.

      The goal is to validate the feasibility and value of conducting routine HCV screening in
      hospitalized patients.
The number of undetected HCV-infected persons has been extrapolated to 75,000 according to
      the results of a 2014 study. Screening efforts have been set up in groups of people said to
      be at high viral risk: drug users, prisoners, precarious persons or migrants from highly
      endemic countries. Nevertheless, the concept of universal screening has not yet been adopted
      by the guardians and the Ministry.

      It is in this context that "hepatitis free hospital" projects have been carried out in
      several French cities such as Nice, Nancy and Marseille.

      The aim of the HOSPI-VHC study is to evaluate the feasibility and efficiency of systematic
      HCV screening in all medical and surgical departments of 4 National Association of
      Hepato-Gastroenterologists of General Hospitals (ANGH) hospitals. This pilot project is part
      of a public health screening program. It will evaluate the interest and usefulness of
      implementing universal screening in hospitalized patients without taking into account the
      existence of viral risk factors. This study will also make it possible to evaluate the
      implementation of a dedicated care pathway: number of patients screened, number of patients
      referred for consultation and number of patients accepting the consultation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: potential patient versus
time frame: 7 days
description: Number of HCV serologies collected compared to the number of patients meeting the inclusion criteria during the study period.
measure: HCV positive
time frame: 7 days
description: Percentage positive for HCV
measure: Follow-up
time frame: 2 months
description: Percentage of patients referred for consultation if HCV positive
measure: Polymerase chain reaction (PCR)
time frame: 7 days
description: Percentage of HCV PCR positive patients
measure: Viral risk factor
time frame: 7 days
description: Percentage of patients with a viral risk factor
measure: hepatic fibrosis
time frame: 7 days
description: Percentage of patients with hepatic fibrosis
measure: treatment initiation
time frame: 2 months
description: Percentage of patients benefiting from treatment initiation
arm group label: Hepatitis C testing
arm group type: Other
description: If the patient is included in the study, HCV serology (2 x 5 ml tubes) will be taken at the time of admission as part of the routine entry assessment.
These two tubes will be used for HCV screening. The patient is informed of the HCV serology result during hospitalization by an investigator.
intervention type: Diagnostic Test
intervention name: Hepatitis C testing
description: Hepatitis C Screening
arm group label: Hepatitis C testing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Isabelle Rosa, PhD
phone: 01 45 17 50 00
phone ext: +33
email: isabelle.rosa@chicreteil.fr
last name: Camille JUNG
phone: 01 45 17 50 00
phone ext: +33
email: camille.jung@chicreteil.fr
facility: 
status: Recruiting
contact: 
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 C
mesh term: Hepatitis
sharing ipd: No