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<docDscr>
  <citation>
    <titlStmt>
      <titl>National Prospective Cohort Follow-Up for Children with Severe Autoimmune Cytopenia</titl>
      <IDNo>FRESH-PEF60196-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="chu" role="">Yves PEREL</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                National Prospective Cohort Follow-Up for Children with Severe Autoimmune Cytopenia            </titl>
      <altTitl>
                    BIOCEREVANCE 1                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF60196-en            </IDNo>
      <IDNo agency="PEF">
                    60196                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF60196                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Nathalie ALADJIDI                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="chu">
        <ExtLink title="ROR" URI="https://ror.org/01hq89f96" role="organisation id"/>
        <ExtLink title="SIREN" URI="263305823" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Yves PEREL                                                                                </AuthEnty>
      <AuthEnty affiliation="chu">
                                    </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="chu" email="nathalie.aladjidi@chu-bordeaux.fr">
                    Nathalie;ALADJIDI
                                            <ExtLink title="ROR" URI="https://ror.org/01hq89f96" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="263305823" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Clinical progression</keyword>
      <keyword vocab="" vocabURI="">
                    prognostic factors</keyword>
      <keyword vocab="" vocabURI="">
                    autoimmune haemolytic anaemia</keyword>
      <keyword vocab="" vocabURI="">
                    Evans syndrome</keyword>
      <keyword vocab="" vocabURI="">
                    chronic immune thrombocytopenic purpura</keyword>
      <keyword vocab="" vocabURI="">
                    research network</keyword>
      <keyword vocab="" vocabURI="">
                    biobank</keyword>
      <keyword vocab="" vocabURI="">
                    physiopathological mechanisms of these diseases</keyword>
      <keyword vocab="" vocabURI="">
                    child</keyword>
      <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="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">
                        Paediatrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D010372"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Immune thrombocytopenic purpura                                            </topcClas>
      <topcClas vocab="cim-11">
                        Autoimmune haemolytic anaemia, warm type                                            </topcClas>
      <topcClas vocab="cim-11">
                        Evans syndrome                                            </topcClas>
    </subject>
    <abstract contentType="purpose">General objective: To prospectively study clinical and paraclinical evolution as well as prognostic factors for autoimmune haemolytic anaemia, Evans syndrome and chronic immune thrombocytopenic purpura among children in France - To generate support for a basic and therapeutic research network for these diseases Secondary objectives - To develop a biobank to study the physiopathological mechanisms of these diseases - To generate support for a national network for epidemiological, clinical, biological and therapeutic research for these diseases</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2008-01-01"/>
      <collDate event="end" date="2011-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <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">Infant, Newborn (birth to 28 days)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D007231"/>
                                                    </universe>
      <universe level="age" clusion="I">Infant (28 days to 2 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D007223"/>
                                                    </universe>
      <universe level="age" clusion="I">Child, Preschool (2 to 5 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002675"/>
                                                    </universe>
      <universe level="age" clusion="I">Child (6 to 12 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002648"/>
                                                    </universe>
      <universe clusion="I">Under 18 years of age and affiliated with a social security scheme - Living in mainland France Patients with AIHA, chronic ITP and/or ES, regardless of underlying factors Free informed written and signed consent by parental authority holders as well as the child or adolescent if they are of age                    </universe>
      <universe clusion="E">constitutional haemolytic anaemia and constitutional platelet disease                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>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>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <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">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>262</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <restrctn>To be decided if data may be used by academic teams To be decided if data may be used by industrial teams</restrctn>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
