<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/NCT02237313</url>
  </required_header>
  <id_info>
    <org_study_id>2014/063/HP</org_study_id>
    <secondary_id>2014A0067740</secondary_id>
    <nct_id>NCT02237313</nct_id>
  </id_info>
  <brief_title>Identification of Vulnerability Factors in the Course of Pemphigus Patients</brief_title>
  <acronym>SHS-Pemphigus</acronym>
  <official_title>Identification of Vulnerability Factors in the Course of Pemphigus Patients - SHS Pemphigus Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The bullous pemphigoid treatment is based on corticosteroids continued for several years.&#xD;
      Pemphigus causes some patients a psychological impact and sometimes major vulnerability that&#xD;
      can occur not only at diagnosis but also at later stages of disease progression. Our&#xD;
      hypothesis is that these episodes of vulnerability may be under four kinds of factors that&#xD;
      may be connected to the plurality of the history of these patients, and the resources they&#xD;
      can mobilize throughout this experience, generating inequality in management and &quot;work&quot;&#xD;
      around the disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The originality of the project lies in its multidisciplinary approach (dermatology,&#xD;
      psychology, sociology). No such study has yet been carried out in the pemphigus who has been&#xD;
      the subject of a very small number of works in sociology or psychology. The only studies are&#xD;
      studies of quality of life with no longitudinal follow-up. The perspective of qualitative and&#xD;
      quantitative data, sociological and psychological approaches, should allow more innovative&#xD;
      and adapted to the medico-social and psychological care of patients with pemphigus&#xD;
      approaches. The purpose of this study is to identify the determinants leading to moments of&#xD;
      vulnerability in the course of patients with pemphigus in order to be able to offer&#xD;
      preventive or corrective actions to improve the experience of the disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2015</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">May 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>analysis of vulnerability factors</measure>
    <time_frame>12 months</time_frame>
    <description>evaluation of : perception by the patient of misdiagnosis, perception of a possible difference in assessment of the severity of his illness between himself and healthcare professionals, patient behavior in relation to available information sources, and the influence of information gathered on the illness experience, Patient trajectory during the diagnostic phase using individual interview and questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>analysis of vulnerability factors</measure>
    <time_frame>6 months</time_frame>
    <description>evaluation of : perception by the patient of misdiagnosis, perception of a possible difference in assessment of the severity of his illness between himself and healthcare professionals, patient behavior in relation to available information sources, and the influence of information gathered on the illness experience, Patient trajectory during the diagnostic phase using individual interview and questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assessment of anxiety, uncertainty, fear, coping strategies</measure>
    <time_frame>12 months</time_frame>
    <description>assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assessment of anxiety, uncertainty, fear, coping strategies</measure>
    <time_frame>6 months</time_frame>
    <description>assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Pemphigus</condition>
  <condition>Dermatological Disease</condition>
  <arm_group>
    <arm_group_label>prevalent cases</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 prevalent cases correspond to patients with known pemphigus. Emphasis will be on included patients at different times of the course of their disease.&#xD;
8 incident cases recruited through the center of Rouen and following an intervention program with psychological support and therapeutic education program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>psychological support and therapeutic education program</intervention_name>
    <arm_group_label>prevalent cases</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient major&#xD;
&#xD;
          -  Patients with pemphigus vulgaris, diagnosed on a combination of:&#xD;
&#xD;
               1. clinical signs and&#xD;
&#xD;
               2. histological image above basal epithelial detachment with intra acantholysis,&#xD;
&#xD;
               3. direct immunofluorescence showing deposition of Immunoglobulin G and / or C3 to&#xD;
                  the surface of keratinocytes&#xD;
&#xD;
          -  Join a social security scheme&#xD;
&#xD;
          -  patient has been informed and have signed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Person placed under judicial protection,&#xD;
&#xD;
          -  Patient without liberty by administrative or judicial decision,&#xD;
&#xD;
          -  Patient participating in another trial for the duration of monitoring.&#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_official>
    <last_name>Pascal Joly, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Rouen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pascal JOLY, Professor</last_name>
    <phone>2 32 88 68 41</phone>
    <phone_ext>+33</phone_ext>
    <email>pacal.joly@chu-rouen.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine PROST-SQUARCIONI, Professor</last_name>
      <phone>1 48 95 77 07</phone>
      <phone_ext>+33</phone_ext>
      <email>catherine.prost@avc.aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Catherine PROST-SQUARCIONI, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand Hôpital d'Estaing</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michel D'Incan, professor</last_name>
      <phone>4 73 75 05 50</phone>
      <phone_ext>+33</phone_ext>
      <email>mdincan@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Michel D'Incan, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH du Mans</name>
      <address>
        <city>le Mans</city>
        <zip>72037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hervé MAILLARD, Professor</last_name>
      <phone>2 43 43 43 58</phone>
      <phone_ext>+33</phone_ext>
      <email>hmaillard@ch-lemans.fr</email>
    </contact>
    <investigator>
      <last_name>Hervé MAILLARD, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille Hôpital Claude Huriez</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emmanuel DELAPORTE, Professor</last_name>
      <phone>3 20 44 41 91</phone>
      <phone_ext>+33</phone_ext>
      <email>Emmanuel.Delaporte@chru-lille.fr</email>
    </contact>
    <investigator>
      <last_name>Emmanuel DELAPORTE, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital La Timone, Assistance publique hôpitaux de Marseille-Aix</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie-Aleth RICHARD LALLEMAND, Professor</last_name>
      <phone>4 91 38 79 91</phone>
      <phone_ext>+33</phone_ext>
      <email>mrichard@ap-hm.fr</email>
    </contact>
    <investigator>
      <last_name>Marie Alteh RICHARD LALLEMAND, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Haut-Lévêque</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie Sylvie DOUTRE, Professor</last_name>
      <email>marie-sylvie.doutre@chu-bordeaux.fr</email>
    </contact>
    <investigator>
      <last_name>Marie Sylvie DOUTRE, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier de Cornouaille</name>
      <address>
        <city>Quimper</city>
        <zip>29107</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ingrid KUPFER-BESSAGUET, Doctor</last_name>
      <phone>2 98 52 60 60</phone>
      <phone_ext>+33</phone_ext>
      <email>i.kupfer@ch-cornouaille.fr</email>
    </contact>
    <investigator>
      <last_name>Ingrid KUPFER-BESSAGUET, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Robert Debré, chu de Reims</name>
      <address>
        <city>Reims</city>
        <zip>51 092</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe BERNARD, Professor</last_name>
      <phone>3 26 78 43 68</phone>
      <phone_ext>+33</phone_ext>
      <email>pbernard@chu-reims.fr</email>
    </contact>
    <investigator>
      <last_name>Philippe BERNARD, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital of Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pascal JOLY, Professor</last_name>
      <phone>2 32 88 80 39</phone>
      <phone_ext>+33</phone_ext>
      <email>Pascal.Joly@chu-rouen.fr</email>
    </contact>
    <investigator>
      <last_name>Sophie DUVERT LEHEMBRE, Doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>psychological support</keyword>
  <keyword>therapeutic education</keyword>
  <keyword>vulnerability of patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pemphigus</mesh_term>
    <mesh_term>Skin Diseases</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/NCT02237313
org study id: 2014/063/HP
secondary id: 2014A0067740
nct id: NCT02237313
lead sponsor: 
has dmc: No
The bullous pemphigoid treatment is based on corticosteroids continued for several years.
      Pemphigus causes some patients a psychological impact and sometimes major vulnerability that
      can occur not only at diagnosis but also at later stages of disease progression. Our
      hypothesis is that these episodes of vulnerability may be under four kinds of factors that
      may be connected to the plurality of the history of these patients, and the resources they
      can mobilize throughout this experience, generating inequality in management and "work"
      around the disease.
The originality of the project lies in its multidisciplinary approach (dermatology,
      psychology, sociology). No such study has yet been carried out in the pemphigus who has been
      the subject of a very small number of works in sociology or psychology. The only studies are
      studies of quality of life with no longitudinal follow-up. The perspective of qualitative and
      quantitative data, sociological and psychological approaches, should allow more innovative
      and adapted to the medico-social and psychological care of patients with pemphigus
      approaches. The purpose of this study is to identify the determinants leading to moments of
      vulnerability in the course of patients with pemphigus in order to be able to offer
      preventive or corrective actions to improve the experience of the disease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: analysis of vulnerability factors
time frame: 12 months
description: evaluation of : perception by the patient of misdiagnosis, perception of a possible difference in assessment of the severity of his illness between himself and healthcare professionals, patient behavior in relation to available information sources, and the influence of information gathered on the illness experience, Patient trajectory during the diagnostic phase using individual interview and questionnaire
measure: analysis of vulnerability factors
time frame: 6 months
description: evaluation of : perception by the patient of misdiagnosis, perception of a possible difference in assessment of the severity of his illness between himself and healthcare professionals, patient behavior in relation to available information sources, and the influence of information gathered on the illness experience, Patient trajectory during the diagnostic phase using individual interview and questionnaire
measure: assessment of anxiety, uncertainty, fear, coping strategies
time frame: 12 months
description: assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire
measure: assessment of anxiety, uncertainty, fear, coping strategies
time frame: 6 months
description: assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire
arm group label: prevalent cases
arm group type: Experimental
description: 40 prevalent cases correspond to patients with known pemphigus. Emphasis will be on included patients at different times of the course of their disease.
8 incident cases recruited through the center of Rouen and following an intervention program with psychological support and therapeutic education program
intervention type: Behavioral
intervention name: psychological support and therapeutic education program
arm group label: prevalent cases
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pascal Joly, Professor
role: Principal Investigator
affiliation: University Hospital, Rouen
last name: Pascal JOLY, Professor
phone: 2 32 88 68 41
phone ext: +33
email: pacal.joly@chu-rouen.fr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
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status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
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status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
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country: France
responsible party type: Sponsor
mesh term: Pemphigus
mesh term: Skin Diseases