xml: <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/NCT06032754</url>
    </required_header>
    <id_info>
      <org_study_id>MVPScS</org_study_id>
      <nct_id>NCT06032754</nct_id>
    </id_info>
    <brief_title>PortoSinusoidal Vascular Diseases and Systemic Sclerosis</brief_title>
    <official_title>PortoSinusoidal Vascular Diseases and Systemic Sclerosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Caen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Caen</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>
        Porto-Sinusoidal Vascular Disorders (PSVD) is a heterogeneous clinico-pathological entity&#xD;
        characterized by alterations in small liver vessels. &quot;Nodular regenerative hyperplasia (NRH)&quot;&#xD;
        is the most common PSVD. The most frequent liver disease associated with Systemic sclerosis&#xD;
        (SSc) is primary biliary cholangitis reported in 2 to 22% of cases. NRH prevalence estimated&#xD;
        to 1.4%, may be underestimated as NRH diagnosis is histologic and usually suspected in case&#xD;
        of complications due to portal hypertension. Few data are available about NRH associated with&#xD;
        SSc resulting in a lack of knowledge of the characteristics and outcome of these patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study aims to compare the outcome of patients with MVPS associated with SSc to patients&#xD;
        with MVPS without SSc. We will conduct a multicenter retrospective study comparing two groups&#xD;
        of adult patients, one with MVPS associated with SSc and the other with MVPS without SSc.&#xD;
        Patients with MVPS associated with SSc will be recruited from French university hospital&#xD;
        departments of Hepatogastroenterology and Internal Medecine. Patients with MVPS without SSc&#xD;
        will be recruited from the Beaujon Hospital database dedicated to liver vascular diseases.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>Prognosis</measure>
      <time_frame>2 years</time_frame>
      <description>To compare prognosis of PSVD patients with or without SSc</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">180</enrollment>
    <condition>PSVD With or Without SSc</condition>
    <arm_group>
      <arm_group_label>First group : SSC with PSVD</arm_group_label>
      <description>medical file analysis of patients affected by SSC and PSVD</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Second group : PVSD without SSC</arm_group_label>
      <description>medical file analysis of patients affected by PSVD only</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Third group : SSC without PVSD</arm_group_label>
      <description>medical file analysis of patients affected by SSC only</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          3 types of patients : PSVD with SSC, PSVD without SSC, SSC without PSVD will be compared.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  PSVD (Valdig criteria)&#xD;
  &#xD;
            -  SSC (ACR/EULAR 2013 criteria)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Liver cirrhosis&#xD;
  &#xD;
            -  Limited scleroderma&#xD;
  &#xD;
            -  Autoimmune hepatitis&#xD;
  &#xD;
            -  Primary biliary cholangitis&#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>ISABELLE OLLIVIER</last_name>
      <phone>+33 2 31 06 45 44</phone>
      <email>ollivierhourmand-i@chu-caen.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chu de Caen</name>
        <address>
          <city>Caen</city>
          <state>Calvados</state>
          <zip>14000</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Isabelle OLLIVIER</last_name>
        <phone>+33 2 31 06 45 44</phone>
        <email>ollivierhourmand-i@chu-caen.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Porto-Sinusoidal Vascular Disorders, Nodular regenerative hyperplasia, Systemic sclerosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vascular Diseases</mesh_term>
      <mesh_term>Scleroderma, Systemic</mesh_term>
      <mesh_term>Scleroderma, Diffuse</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032754
  org study id: MVPScS
  nct id: NCT06032754
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Porto-Sinusoidal Vascular Disorders (PSVD) is a heterogeneous clinico-pathological entity
        characterized by alterations in small liver vessels. "Nodular regenerative hyperplasia (NRH)"
        is the most common PSVD. The most frequent liver disease associated with Systemic sclerosis
        (SSc) is primary biliary cholangitis reported in 2 to 22% of cases. NRH prevalence estimated
        to 1.4%, may be underestimated as NRH diagnosis is histologic and usually suspected in case
        of complications due to portal hypertension. Few data are available about NRH associated with
        SSc resulting in a lack of knowledge of the characteristics and outcome of these patients.
  The study aims to compare the outcome of patients with MVPS associated with SSc to patients
        with MVPS without SSc. We will conduct a multicenter retrospective study comparing two groups
        of adult patients, one with MVPS associated with SSc and the other with MVPS without SSc.
        Patients with MVPS associated with SSc will be recruited from French university hospital
        departments of Hepatogastroenterology and Internal Medecine. Patients with MVPS without SSc
        will be recruited from the Beaujon Hospital database dedicated to liver vascular diseases.
  observational model: Cohort
  time perspective: Retrospective
  measure: Prognosis
  time frame: 2 years
  description: To compare prognosis of PSVD patients with or without SSc
  arm group label: First group : SSC with PSVD
  description: medical file analysis of patients affected by SSC and PSVD
  arm group label: Second group : PVSD without SSC
  description: medical file analysis of patients affected by PSVD only
  arm group label: Third group : SSC without PVSD
  description: medical file analysis of patients affected by SSC only
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: ISABELLE OLLIVIER
  phone: +33 2 31 06 45 44
  email: ollivierhourmand-i@chu-caen.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Vascular Diseases
  mesh term: Scleroderma, Systemic
  mesh term: Scleroderma, Diffuse
  mesh term: Sclerosis