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<docDscr>
  <citation>
    <titlStmt>
      <titl>Iatrogenic risks associated with CT scans received in childhood</titl>
      <IDNo>FRESH-PEF5108-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" role="">Florent DE VATHAIRE</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Iatrogenic risks associated with CT scans received in childhood            </titl>
      <altTitl>
                    TOMENF                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF5108-en            </IDNo>
      <IDNo agency="PEF">
                    5108                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF5108                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Florent DE VATHAIRE                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)">
        <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
        <ExtLink title="SIREN" URI="180036048" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            EUROPEAN COMMISSION RESEARCH                    
                                    </fundAg>
      <fundAg>
                                            ELECTRICITE DE FRANCE (EDF)                    
                                    </fundAg>
      <fundAg>
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" email="florent.devathaire@gustaveroussy.fr">
                    Florent;DE VATHAIRE
                                            <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="180036048" 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="">
                    CT scan</keyword>
      <keyword vocab="" vocabURI="">
                    medical exposure</keyword>
      <keyword vocab="" vocabURI="">
                    iatrogenic effects of radiation</keyword>
      <keyword vocab="" vocabURI="">
                    low doses of ionizing radiation</keyword>
      <keyword vocab="" vocabURI="">
                    cerebrovascular disease</keyword>
      <keyword vocab="" vocabURI="">
                    dosimetry</keyword>
      <keyword vocab="" vocabURI="">
                    childhood</keyword>
      <keyword vocab="" vocabURI="">
                    risk factors</keyword>
      <keyword vocab="" vocabURI="">
                    cohort</keyword>
      <keyword vocab="" vocabURI="">
                    cardiovascular disease</keyword>
      <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="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="cim-11">
                        Malignant neoplasms of ill-defined or unspecified primary sites                                            </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">The main objective is to identify group of children who received CT scan and to study the long-term effects of the radiation in order to gain knowledge about all potential iatrogenic effects after exposure to CT scan in childhood by means of a cohort study. The study aims to: - identify a potential risk of radiation-induced cancer after CT scan in childhood, and quantify if any; - identify the factors affecting this potential risk, namely, the relationship with the dose received by the organ, the percentage of the irradiated body, age at CT scan, gender and possibly other carcinogenic factors. Secondary objectives are to identify potential risks of other radiation-induced diseases such as cerebrovascular and cardiovascular diseases and quantify them if they exist.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2009-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">General 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 (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">Child under 15 years at the CT scan - CT scan received for reasons other than suspicion of tumor - CT scan in the period 1998-2008 - Children whose main residence is in France at the time of CT scan                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</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>[10000-20000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>11 000</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
    <notes>This study is the French part of an international study (CHILD-MED-RAD: Cohort studies of children with substantial businesses diagnostic medical exposures). The International Agency for Research on Cancer (IARC) of the WHO (Lyon) has access to non-personal data.</notes>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
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