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<docDscr>
  <citation>
    <titlStmt>
      <titl>Prospective Breast and Ovarian Genetic Study: genetic predisposition to breast and ovarian cancer: a prospective study of BRCA mutation carriers</titl>
      <IDNo>FRESH-PEF60053-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="INSTITUT CURIE" role="">Catherine NOGUES</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Prospective Breast and Ovarian Genetic Study: genetic predisposition to breast and ovarian cancer: a prospective study of BRCA mutation carriers            </titl>
      <altTitl>
                    GENEPSO                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF60053-en            </IDNo>
      <IDNo agency="PEF">
                    60053                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF60053                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Catherine NOGUES                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="INSTITUT CURIE">
        <ExtLink title="ROR" URI="https://ror.org/04t0gwh46" role="organisation id"/>
        <ExtLink title="SIREN" URI="784257164" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Emmanuelle FOURME                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="INSTITUT CURIE">
        <ExtLink title="ROR" URI="https://ror.org/04t0gwh46" role="organisation id"/>
        <ExtLink title="SIREN" URI="784257164" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            INSTITUT CURIE                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            FONDATION DE FRANCE                    
                                    </fundAg>
      <fundAg>
                                            LIGUE NATIONALE CONTRE LE CANCER (LNCC)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="INSTITUT CURIE" email="noguesc@ipc.unicancer.fr">
                    Catherine;NOGUES
                                            <ExtLink title="ROR" URI="https://ror.org/04t0gwh46" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="784257164" role="organisation id"/>
                                    </contact>
      <contact affiliation="INSTITUT CURIE" email="emmanuelle.fourme@curie.net">
                    Emmanuelle;FOURME
                                            <ExtLink title="ROR" URI="https://ror.org/04t0gwh46" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="784257164" 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="">
                    BRCA gene mutation</keyword>
      <keyword vocab="" vocabURI="">
                    standardised collection</keyword>
      <keyword vocab="" vocabURI="">
                    prospective follow-up</keyword>
      <keyword vocab="" vocabURI="">
                    Health events</keyword>
      <keyword vocab="" vocabURI="">
                    death</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 determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">General objective: to form a cohort of BRCA gene mutation carriers for standardised data collection and to establish a prospective follow-up over 10 years. Treatment for families can be improved by resolving certain questions (projects with associated INSERM teams): 1) what is the risk of developing breast and/or ovarian cancer for gene mutation carriers during their lifetime? 2) are cancer risks modified by environmental factors (in particular medical radiation), hormonal factors (endogenous or exogenous), or other genetic factors? 3) should the same parameters be used to evaluate the prognosis of sporadic cancer? 4) what is the psychological and social impact for people with a known predisposition to breast and/or ovarian cancer?</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="1999-01-01"/>
      <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">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">Adult subjects with no mental disability who are BRCA genetic mutation carriers                    </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
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>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>1425</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <restrctn>Data may be used by academic teams Data may be used by industrial teams</restrctn>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
