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<docDscr>
  <citation>
    <titlStmt>
      <titl>Cohorte sur le risque de cancer après cardiologie interventionnelle pédiatrique</titl>
      <IDNo>FRESH-PEF6330-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)" role="">Estelle RAGE</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Cohorte sur le risque de cancer après cardiologie interventionnelle pédiatrique            </titl>
      <altTitl>
                    COCCINELLE                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF6330-en            </IDNo>
      <IDNo agency="PEF">
                    6330                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF6330                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Hélène BAYSSON                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)">
        <ExtLink title="ROR" URI="https://ror.org/04dbtaf18" role="organisation id"/>
        <ExtLink title="SIREN" URI="130001803" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Marie-Odile BERNIER                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)">
        <ExtLink title="ROR" URI="https://ror.org/04dbtaf18" role="organisation id"/>
        <ExtLink title="SIREN" URI="130001803" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Dominique LAURIER                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)">
        <ExtLink title="ROR" URI="https://ror.org/04dbtaf18" role="organisation id"/>
        <ExtLink title="SIREN" URI="130001803" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)                    
                                    </fundAg>
      <fundAg>
                                            INSTITUT NATIONAL DU CANCER (INCA)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)" email="helene.baysson@irsn.fr">
                    Hélène;BAYSSON
                                            <ExtLink title="ROR" URI="https://ror.org/04dbtaf18" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="130001803" role="organisation id"/>
                                    </contact>
      <contact affiliation="AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)" email="marie-odile.bernier@irsn.fr">
                    Marie-Odile;BERNIER
                                            <ExtLink title="ROR" URI="https://ror.org/04dbtaf18" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="130001803" role="organisation id"/>
                                    </contact>
      <contact affiliation="AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)" email="dominique.laurier@irsn.fr">
                    Dominique;LAURIER
                                            <ExtLink title="ROR" URI="https://ror.org/04dbtaf18" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="130001803" 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="">
                    ionizing radiation</keyword>
      <keyword vocab="" vocabURI="">
                    interventional cardiology</keyword>
      <keyword vocab="" vocabURI="">
                    cancer</keyword>
      <keyword vocab="" vocabURI="">
                    children</keyword>
      <topcClas vocab="health theme">
                        Oncology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D008495"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Cardiology and vascular medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/4455c187-2f2f-4cd1-a4dd-449f59d73b39"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D002309"/>
                                                </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>
    </subject>
    <abstract contentType="purpose">Children with congenital heart disease frequently undergo cardiac catheterization procedures for diagnostic or treatment purposes. Despite the clear clinical benefit to the patient, the complexity of these procedures may result in high cumulative radiation exposure. Given children's greater sensitivity to radiation and the longer life span during which radiation health effects can develop, an epidemiological cohort study, named Coccinelle (Cohorte sur le risque de cancer après cardiologie interventionnelle pédiatrique) is being launched in France to evaluate the risks of leukaemia and solid cancers in this specific population.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2011-01-01"/>
      <collDate event="end" date="2014-01-01"/>
      <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">The study population will include all children who have undergone at least one cardiac catheterization procedure since 2000 and were under 10 years old and permanent residents of France at the time of the procedure. Electronically stored patient records from the departments of paediatric cardiology of the French national network for complex congenital heart diseases (M3C) are being searched to identify the children to be included.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Other</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>[1000-10000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>8000</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
