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<docDscr>
  <citation>
    <titlStmt>
      <titl>Multicentric prospective cohort of children and adolescents malignant hemopathies</titl>
      <IDNo>FRESH-PEF3269-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="UNIVERSITE D&amp;#x27;AIX MARSEILLE" role="">Françoise VION-DURY</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Multicentric prospective cohort of children and adolescents malignant hemopathies            </titl>
      <altTitl>
                    LEA                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF3269-en            </IDNo>
      <IDNo agency="PEF">
                    3269                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF3269                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Pascal AUQUIER                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)">
        <ExtLink title="ROR" URI="https://ror.org/002cp4060" role="organisation id"/>
        <ExtLink title="SIREN" URI="261300081" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Gérard MICHEL                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)">
        <ExtLink title="ROR" URI="https://ror.org/002cp4060" role="organisation id"/>
        <ExtLink title="SIREN" URI="261300081" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Marie-Claude SIMEONI                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)">
        <ExtLink title="ROR" URI="https://ror.org/002cp4060" role="organisation id"/>
        <ExtLink title="SIREN" URI="261300081" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE REGIONALE D&amp;#039;HOSPITALISATION (ARH)                    
                                    </fundAg>
      <fundAg>
                                            ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)                    
                                    </fundAg>
      <fundAg>
                                            AGENCE DE LA BIOMEDECINE                    
                                    </fundAg>
      <fundAg>
                                            AGENCE NATIONALE DE LA RECHERCHE (ANR)                    
                                    </fundAg>
      <fundAg>
                                            ASSOCIATION LAURETTE FUGAIN                    
                                    </fundAg>
      <fundAg>
                                            BRISTOL MYERS SQUIBB PHARMA FRANCE S.A                    
                                    </fundAg>
      <fundAg>
                                            GUERIDUNCANCER                    
                                    </fundAg>
      <fundAg>
                                            INSTITUT NATIONAL DU CANCER (INCA)                    
                                    </fundAg>
      <fundAg>
                                            LIGUE NATIONALE CONTRE LE CANCER (LNCC)                    
                                    </fundAg>
      <fundAg>
                                            MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES                    
                                    </fundAg>
      <fundAg>
                                            MSD FRANCE                    
                                    </fundAg>
      <fundAg>
                                            REGION PACA                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)" email="pascal.auquier@univ-amu.fr">
                    Pascal;AUQUIER
                                            <ExtLink title="ROR" URI="https://ror.org/002cp4060" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="261300081" role="organisation id"/>
                                    </contact>
      <contact affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)" email="gmichel@ap-hm.fr">
                    Gérard;MICHEL
                                            <ExtLink title="ROR" URI="https://ror.org/002cp4060" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="261300081" role="organisation id"/>
                                    </contact>
      <contact affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)" email="marie-claude.simeoni@univ-amu.fr">
                    Marie-Claude;SIMEONI
                                            <ExtLink title="ROR" URI="https://ror.org/002cp4060" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="261300081" 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="">
                    Malignant hemopathies</keyword>
      <keyword vocab="" vocabURI="">
                    Leukemia</keyword>
      <keyword vocab="" vocabURI="">
                    Lymphoma</keyword>
      <keyword vocab="" vocabURI="">
                    Sequelae of leukemia or its treatment</keyword>
      <keyword vocab="" vocabURI="">
                    long term adverse side effects</keyword>
      <keyword vocab="" vocabURI="">
                    children</keyword>
      <keyword vocab="" vocabURI="">
                    adolescents</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">
                        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">
                        Diseases of the blood or blood-forming organs                                            </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">General objective of the project : Describe the evolution at short and medium term of a cohort of patient treated for malignant hemopathy during their childhood, concerning: . quality of life in patient and its relatives . socio-economic insertion . health condition . relation to the health care system Study the determinants (medical, socio-economic, behavioral or environmental) of the evolution (health condition and quality of life) at medium and long term of a cohort of patients treated for malignant hemopathy during their childhood. Study predictive factors of the occurrence of long term sequelae of height and weight growth, puberty, fertility, thyroid function, visual function, cardiac function, viral contamination, pulmonary function, bone metabolism, iron metabolism, metabolic syndrome, other sequelae. Explore mortality/survival of the patients of this cohort after malignant hemopathy treatment in childhood. Compare the quality of life in patients treated for malignant hemopathy to the one of subjects of same gender and age, control subjects in good health or suffering of chronic diseases. Project perspectives: Concerning literature, knowledge of the determinants of health condition and quality of life in patients after a malignant hemopathy treatment during childhood is today too fragmented to propose care strategies to improve the future of these children. Taking into account the constitution limits of the Childhood Cancer Survivor Study, the cohort LEA showed its feasibility on the period 2004-2013. Nevertheless, today it’s necessary to enlarge the representative base of this cohort, joining to the project the large care centers for children malignant hemopathies in France, and creating a more multi-disciplinary research consortium (HOPE-EPI). Funding requested in the context of ANR (Great loan) aim to carry on the work realized and to improve the program on the following main points: rise of the number of patients included, taking into account of largest panel of determinants, association with new clinical research teams. A partnership with the national register of children malignant hemopathies (directed by J.Clavel) will be established, allowing to optimize completeness of the active thread. Moreover, actual large multi-central French protocols for children lymphoblastic and myeloblastic acute leukemia treatment (EORTC, FRALLE, ELAM) are represented in the project by the inclusion of new centers.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2004-01-01"/>
      <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">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 level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe clusion="I">Patients with lymphoma, acute lymphoblastic and myeloblastic leukemia, aged less than 18 at the moment of the diagnosis, and diagnosed after January 1980. Patients are in a condition of hematological remission, and the treatment of the acute leukemia has begun in one of the investigation centers. Other criteria: resident in France, agree to participate, or parents agree for their minor children participation.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Quality of life/health perception</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>Psychological tests/clinical scales (depression, cognition, quality of life, etc.)                                                            <concept vocab="CESSDA" vocabURI="MeasurementsAndTests.Psychological"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>2385 patients (2003+2007+2008+2009+2010+2011+2012+2013)</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>
