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<docDscr>
  <citation>
    <titlStmt>
      <titl>REGISTRY OF AUTOIMMUNE CYTOPENIAS IN FRANCE</titl>
      <IDNo>FRESH-PEF5294-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)" role="">Guillaume MOULIS</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                REGISTRY OF AUTOIMMUNE CYTOPENIAS IN FRANCE            </titl>
      <altTitl>
                    CARMEN-France                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF5294-en            </IDNo>
      <IDNo agency="PEF">
                    5294                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF5294                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Guillaume MOULIS                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)">
        <ExtLink title="ROR" URI="https://ror.org/017h5q109" role="organisation id"/>
        <ExtLink title="SIREN" URI="263100125" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="French network of autoimmune cytopenia (CeReCAI). European Research Consortium on ITP (ERCI)" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </producer>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)                    
                                    </fundAg>
      <fundAg>
                                            CSL BEHRING S.A.                    
                                    </fundAg>
      <fundAg>
                                            NOVARTIS PHARMA SAS                    
                                    </fundAg>
      <fundAg>
                                            SOCIETE NATIONALE FRANCAISE DE MEDECINE INTERNE (SNFMI)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)" email="moulis.g@chu-toulouse.fr">
                    Guillaume;MOULIS
                                            <ExtLink title="ROR" URI="https://ror.org/017h5q109" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="263100125" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    immune thromboctyopenia</keyword>
      <keyword vocab="" vocabURI="">
                    autoimmune hemolytic anemia</keyword>
      <keyword vocab="" vocabURI="">
                    registry</keyword>
      <keyword vocab="" vocabURI="">
                    epidemiology</keyword>
      <keyword vocab="" vocabURI="">
                    pharmacoepidemiology</keyword>
      <topcClas vocab="health theme">
                        Hematology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/9239f328-78c9-40a5-a0b9-8e66fd9b6245"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D006402"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Clinical immunology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/7a3cf568-46ba-4840-be8f-f22fc030139f"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D000486"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Immune thrombocytopenic purpura                                            </topcClas>
      <topcClas vocab="cim-11">
                        Acquired haemolytic anaemia, immune                                            </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Environmental determinants: Other                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants: Employment                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">To describe the epidemiology of immune thrombocytopenic purpura (ITP) and of autoimmune hemolytic anemia (AIHA), assess their mangement and provide RWE of their treatments in terms of effectiveness and safety</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2013-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Grand Est</geogCover>
      <geogCover>Nouvelle-Aquitaine</geogCover>
      <geogCover>Auvergne Rhône-Alpes</geogCover>
      <geogCover>Bourgogne Franche-Comté</geogCover>
      <geogCover>Bretagne</geogCover>
      <geogCover>Centre-Val de Loire</geogCover>
      <geogCover>Ile-de-France</geogCover>
      <geogCover>Occitanie</geogCover>
      <geogCover>Hauts-de-France</geogCover>
      <geogCover>Normandie</geogCover>
      <geogCover>Pays de la Loire</geogCover>
      <geogCover>Provence - Alpes - Côte d\'Azur</geogCover>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">aged 18 or over - new diagnosis of ITP (since 2025, initiation of a maintenance treatment ofr ITP) or AIHA or initiaiton of a newly marketed drug in France for ITP or AIHA - no oppsition to participate                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
    <qualityStatement>
      <otherQualityStatement>Remote data quality check for all patients on a core set of 100 variables; on-site monitoring done in 2023-2024 in centers in 10% of the database</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services
Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[1000-10000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Morbidity registry                    </notes>
    <notes subject="follow-up">
                        Monitoring by contact with the participant (mail, e-mail, telephone etc.)                    </notes>
    <anlyInfo>
      <respRate>2832 on December 31, 2024</respRate>
    </anlyInfo>
    <stdyClas>Ongoing study</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Upon request, need the apprival by the scientific committee and the sponsor</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
