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<docDscr>
  <citation>
    <titlStmt>
      <titl>Study on Long-Term Outcome for Subjects Cured of Childhood Cancer and Adolescents Diagnosed Before 2000 in France</titl>
      <IDNo>FRESH-PEF3229-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>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Study on Long-Term Outcome for Subjects Cured of Childhood Cancer and Adolescents Diagnosed Before 2000 in France            </titl>
      <altTitl>
                    FCCSS                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF3229-en            </IDNo>
      <IDNo agency="PEF">
                    3229                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF3229                </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>
      <AuthEnty>
                    Carole RUBINO                                                                                                                            </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>
    </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>
      <contact affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" email="carole.rubino@gustaveroussy.fr">
                    Carole;RUBINO
                                            <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="180036048" 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="">
                    iatrogenic effects</keyword>
      <keyword vocab="" vocabURI="">
                    social integration</keyword>
      <keyword vocab="" vocabURI="">
                    radiology</keyword>
      <keyword vocab="" vocabURI="">
                    radiotherapy</keyword>
      <keyword vocab="" vocabURI="">
                    chemotherapy</keyword>
      <keyword vocab="" vocabURI="">
                    quality of life</keyword>
      <keyword vocab="" vocabURI="">
                    France</keyword>
      <keyword vocab="" vocabURI="">
                    mortality</keyword>
      <keyword vocab="" vocabURI="">
                    cohort</keyword>
      <keyword vocab="" vocabURI="">
                    solid cancer in childhood and adolescence</keyword>
      <keyword vocab="" vocabURI="">
                    subsequent cerebrovascular and cardiovascular diseases</keyword>
      <keyword vocab="" vocabURI="">
                    survivors</keyword>
      <keyword vocab="" vocabURI="">
                    risk factors of iatrogenic pathologies</keyword>
      <keyword vocab="" vocabURI="">
                    dosimetric reconstruction</keyword>
      <keyword vocab="" vocabURI="">
                    second cancer</keyword>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants: Employment                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Addiction                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">The main objective of the study is to improve knowledge about the long-term health and social outcomes for children and adults cured of cancer. The FCCSS particularly focuses on: - Estimating the incidence of iatrogenic diseases occurring after long-term treatment of a childhood tumour; - Identifying and quantifying risk factors associated with these diseases in order to reduce iatrogenic risks and customise treatment; - Identifying clinical markers of the progression of these diseases in order to improve early diagnosis and treatment - Implementing customised follow-up consultations and the preventative actions required. This study was implemented in order to increase knowledge on the long-term social and health implications of cancer treatment received during childhood. The FCCSS follows the Euro2K study, which showed that survivors of childhood cancer are at a significantly high risk of serious iatrogenic events (e.g. long-term mortality, second cancer, diabetes, cardiac diseases, and cerebrovascular disease).</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="1985-01-01"/>
      <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">Subjects under 21 years old diagnosed with cancer before 2000 in France.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>International Classification of Diseases (ICD-O</standardName>
          <standardName>ICD-9</standardName>
          <standardName>ICD-10); DCI</standardName>
          <standardName>INSEE municipality and country codes.</standardName>
        </standard>
      </standardsCompliance>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services
Quality of life/health perception
Others</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>- 4,500 (1942-1985) - Euro2K - 10,000 (2000) - 16,000 (2014).</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>The use of anonymised data on the outcome of children cured of cancer from the top 5 cancer centers is possible for any research by a team with proven experience in the field of expertise. Usage is determined on a case-by-case and is governed by an agreement. The use of anonymised FCCSS data shall be possible for any external research team involvong the outcome of children cured of cancer and shall be determined on a case-by-case basis following submission of the project to the cohort scientific committee. Participants from paediatric oncology departments will have access to their patients&amp;#x27; data.</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
