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<docDscr>
  <citation>
    <titlStmt>
      <titl>Etude observationnelle de la prise en charge du mélanome métastatique en France</titl>
      <IDNo>FRESH-PEF73340-fr</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="MSD FRANCE" role="">Laurie LEVY-BACHELOT</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Etude observationnelle de la prise en charge du mélanome métastatique en France            </titl>
      <altTitl>
                    AMEL                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73340-fr            </IDNo>
      <IDNo agency="PEF">
                    73340                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73340                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Chloé GODARD                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="MSD FRANCE">
        <ExtLink title="ROR" URI="https://ror.org/00kt5kp12" role="organisation id"/>
        <ExtLink title="SIREN" URI="417890589" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            MSD FRANCE                    
                                    </producer>
      <prodPlac>
                Portail Epidémiologie France (PEF)            </prodPlac>
      <fundAg>
                                            MSD FRANCE                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="MSD FRANCE" email="chloe.godard@merck.com">
                    Chloé;GODARD
                                            <ExtLink title="ROR" URI="https://ror.org/00kt5kp12" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="417890589" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-18"/>
      <distDate date="2026-06-18"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <studyAuthorization>
    <authorizingAgency>CNIL                </authorizingAgency>
  </studyAuthorization>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <topcClas vocab="health theme">
                        Oncologie                                                        <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">
                        Tumeurs                                            </topcClas>
    </subject>
    <abstract contentType="purpose">Décrire le profil sociodémographique et clinique des patients atteints de mélanome métastatique ainsi que leur prise en charge thérapeutique</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date=""/>
      <collDate event="end" date=""/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individus            </anlyUnit>
      <universe level="type" clusion="I">Patients                    </universe>
      <universe level="sex" clusion="I">Masculin                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Féminin                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Adulte (19 à 24 ans)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adulte (25 à 44 ans)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Adulte (45 à 64 ans)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Personne âgée (65 à 79 ans)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Grand âge (80 ans et plus)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">Critères d'inclusion: •History of histopathologically confirmed diagnosis of cutaneous melanoma  •Unresectable stage III (per treating physician) or stage IV melanoma according to AJCC (2009) classification at diagnosis or upon progression following diagnosis   •Subject’s index date is  between January 1st, 2012 and October 31st, 2012.  •Age &gt;= 18 years at the index date •Access to the complete records from the index date until the end of the data extraction period  or death whichever is earlier                     </universe>
      <universe clusion="E">•Patients with primary non-cutaneous melanoma including primary ocular melanoma  •Patients with an index date before January 1st, 2012 or after 31st October, 2012  •Patients with resectable melanoma who have not relapsed                    </universe>
      <dataKind>Données cliniques</dataKind>
      <dataKind>Données socio-démographiques</dataKind>
      <dataKind>Données économiques</dataKind>
    </sumDscr>
  </stdyInfo>
  <method>
    <dataColl>
      <sampProc>Autre                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individus                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Transcription et saisie d’informations dans un enregistrement structuré                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
      <collMode>Entretien avec le participant (dont clinique)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Etude observationnelle</notes>
    <notes subject="research type">
                        Etude observationnelle                    </notes>
    <anlyInfo>
      <respRate>271 patients inclus</respRate>
    </anlyInfo>
    <stdyClas>Inconnu</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            A définir                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Pas d’accès</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
