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<docDscr>
  <citation>
    <titlStmt>
      <titl>Cohort of Breast Cancer Patients. Identification of Genetic Determinants that Influence Resistance/Sensitivity and/or Toxicity to Adjuvant Cancer Treatment and Genetic Determinants for Developing Breast Cancer.</titl>
      <IDNo>FRESH-PEF73302-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)" role="">Jacques ROPERS</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Cohort of Breast Cancer Patients. Identification of Genetic Determinants that Influence Resistance/Sensitivity and/or Toxicity to Adjuvant Cancer Treatment and Genetic Determinants for Developing Breast Cancer.            </titl>
      <altTitl>
                    SIGNAL                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73302-en            </IDNo>
      <IDNo agency="PEF">
                    73302                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73302                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Hélène BLANCHE-KOCH                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE ETUDES POLYMORPHISME HUMAIN (CEPH)">
        <ExtLink title="ROR" URI="https://ror.org/01rje3r53" role="organisation id"/>
        <ExtLink title="SIREN" URI="333466407" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Jean-François DELEUZE                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE ETUDES POLYMORPHISME HUMAIN (CEPH)">
        <ExtLink title="ROR" URI="https://ror.org/01rje3r53" role="organisation id"/>
        <ExtLink title="SIREN" URI="333466407" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Xavier PIVOT                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CHU BESANCON (CHU)">
        <ExtLink title="ROR" URI="https://ror.org/0084te143" role="organisation id"/>
        <ExtLink title="SIREN" URI="262501760" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Céline FAURE-MERCIER                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="INSTITUT NATIONAL DU CANCER (INCA)">
        <ExtLink title="ROR" URI="https://ror.org/03m8vkq32" role="organisation id"/>
        <ExtLink title="SIREN" URI="187512777" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    David COX                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE CLAUDE BERNARD LYON 1">
        <ExtLink title="ROR" URI="https://ror.org/029brtt94" role="organisation id"/>
        <ExtLink title="SIREN" URI="196917744" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="ICGC (International Consortium of Genomics of Cancer)" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            INSTITUT NATIONAL DU CANCER (INCA)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            INSTITUT NATIONAL DU CANCER (INCA)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE ETUDES POLYMORPHISME HUMAIN (CEPH)" email="blanche@cephb.fr">
                    Hélène;BLANCHE-KOCH
                                            <ExtLink title="ROR" URI="https://ror.org/01rje3r53" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="333466407" role="organisation id"/>
                                    </contact>
      <contact affiliation="CENTRE ETUDES POLYMORPHISME HUMAIN (CEPH)" email="deleuze@cng.fr">
                    Jean-François;DELEUZE
                                            <ExtLink title="ROR" URI="https://ror.org/01rje3r53" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="333466407" role="organisation id"/>
                                    </contact>
      <contact affiliation="CHU BESANCON (CHU)" email="xpivot@strasbourg.unicancer.fr">
                    Xavier;PIVOT
                                            <ExtLink title="ROR" URI="https://ror.org/0084te143" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="262501760" role="organisation id"/>
                                    </contact>
      <contact affiliation="INSTITUT NATIONAL DU CANCER (INCA)" email="cfaure@institutcancer.fr">
                    Céline;FAURE-MERCIER
                                            <ExtLink title="ROR" URI="https://ror.org/03m8vkq32" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="187512777" role="organisation id"/>
                                    </contact>
      <contact affiliation="UNIVERSITE CLAUDE BERNARD LYON 1" email="david.cox@inserm.fr">
                    David;COX
                                            <ExtLink title="ROR" URI="https://ror.org/029brtt94" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="196917744" 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="">
                    genetic determinant</keyword>
      <keyword vocab="" vocabURI="">
                    breast</keyword>
      <keyword vocab="" vocabURI="">
                    cancer</keyword>
      <keyword vocab="" vocabURI="">
                    treatment</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="cim-11">
                        Malignant neoplasms of breast                                            </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">The aims of this study are: — to identify determinants that influence resistance or sensitivity following adjuvant treatment with Herceptin®; — to identify determinants of cardiac toxicity following adjuvant treatment with Herceptin®; — to identify genetic determinants for developing different types of breast cancer: HER2+, triple negative, RH+; — to identify genetic determinants for developing breast cancer.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2009-01-01"/>
      <collDate event="end" date="2017-01-01"/>
      <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">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 level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">1. Women over 18 years old.  2. Histologically confirmed, non-metastatic, operable breast adenocarcinoma. 3. HER2+ tumour: all patients undergoing adjuvant treatment with Trastuzumab.  4. Signed informed consent.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</dataKind>
    </sumDscr>
    <qualityStatement>
      <otherQualityStatement>Implemented by independent operators</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services</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>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>9,600</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
      <complete>Fully anonymised clinical data (no initials or order number; returned to correlation table; no date of birth; no reference to the healthcare centre or investigator that enrolled the patient)</complete>
    </setAvail>
    <useStmt>
      <citReq>Requesting parties undertake to reference the study and its sponsor in all publications resulting from these data.</citReq>
      <conditions>may be made readily available to third parties: please contact those in charge of the study.</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Free access</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
