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<docDscr>
  <citation>
    <titlStmt>
      <titl>Iatrogenic effects in long-term following radiotherapy for a childhood skin hemangioma at Gustave Roussy between 1941 and 1973</titl>
      <IDNo>FRESH-PEF5802-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>
                Iatrogenic effects in long-term following radiotherapy for a childhood skin hemangioma at Gustave Roussy between 1941 and 1973            </titl>
      <altTitl>
                    ANGIO                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF5802-en            </IDNo>
      <IDNo agency="PEF">
                    5802                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF5802                </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="FCCSS, EpiRadBio, CerebRad, Pirates, Swedish and French cohort of patients irradiated for hemangioma in childhood" type="collaboration">
                                    </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>
                                            ELECTRICITE DE FRANCE (EDF)                    
                                    </fundAg>
      <fundAg>
                                            FONDATION DE FRANCE                    
                                    </fundAg>
      <fundAg>
                                            LIGUE NATIONALE CONTRE LE CANCER (LNCC)                    
                                    </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="">
                    hemangioma in childhood</keyword>
      <keyword vocab="" vocabURI="">
                    late effects</keyword>
      <keyword vocab="" vocabURI="">
                    radiotherapy</keyword>
      <keyword vocab="" vocabURI="">
                    iatrogenic effects</keyword>
      <keyword vocab="" vocabURI="">
                    adults</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="cim-11">
                        Haemangioma, NOS                                            </topcClas>
      <topcClas vocab="cim-11">
                        Benign neoplasm of endocrine glands                                            </topcClas>
      <topcClas vocab="cim-11">
                        Unspecified carcinoma of unspecified site                                            </topcClas>
      <topcClas vocab="cim-11">
                        Malignant neoplasms of breast                                            </topcClas>
      <topcClas vocab="cim-11">
                        Malignant melanoma, NOS                                            </topcClas>
    </subject>
    <abstract contentType="purpose">The study aims to evaluate the consequences in long-term that can be caused by radiation in hemangioma childhood, treated between 1941 and 1973 in Gustave Roussy (France). The main objective of the study is to inform the patients about the treatment they had received so that they can inform their physician. Another objective is to estimate the mortality by cancer and the incidence of cancers (including thyroid and breast cancer, two of the most radiosensitive organs) taking into account the dose of ionizing radiation received at the site of the tumor.</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">patients treated by radiotherapy for childhooh hemangioma                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health 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>[1000-10000[ 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>
    <anlyInfo>
      <respRate>8320</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Data can be used (conditions for access to define)</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
