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<docDscr>
  <citation>
    <titlStmt>
      <titl>Prospective Cohort of Patients Receiving Neoadjuvant Chemotherapy for Breast Cancer</titl>
      <IDNo>FRESH-PEF60092-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTR GEORGES FRANCOIS LECLERC" role="">François GHIRINGHELLI</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Prospective Cohort of Patients Receiving Neoadjuvant Chemotherapy for Breast Cancer            </titl>
      <altTitl>
                    BREAST CANCER CHEMOTHERAPY                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF60092-en            </IDNo>
      <IDNo agency="PEF">
                    60092                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF60092                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    François GHIRINGHELLI                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTR GEORGES FRANCOIS LECLERC">
        <ExtLink title="ROR" URI="https://ror.org/00pjqzf38" role="organisation id"/>
        <ExtLink title="SIREN" URI="778204271" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            CENTR GEORGES FRANCOIS LECLERC                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTR GEORGES FRANCOIS LECLERC" email="francois.ghiringhelli@inserm.fr">
                    François;GHIRINGHELLI
                                            <ExtLink title="ROR" URI="https://ror.org/00pjqzf38" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="778204271" 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="">
                    state</keyword>
      <keyword vocab="" vocabURI="">
                    local recurrence</keyword>
      <keyword vocab="" vocabURI="">
                    metastatic</keyword>
      <keyword vocab="" vocabURI="">
                    histological data</keyword>
      <keyword vocab="" vocabURI="">
                    imaging</keyword>
      <keyword vocab="" vocabURI="">
                    Health episodes</keyword>
      <keyword vocab="" vocabURI="">
                    death</keyword>
      <keyword vocab="" vocabURI="">
                    treatment</keyword>
      <keyword vocab="" vocabURI="">
                    classification</keyword>
      <keyword vocab="" vocabURI="">
                    surgery</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">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">General objective: To evaluate the medical, clinical, biological and therapeutic characteristics of breast cancer patients receiving neoadjuvant chemotherapy Secondary objectives: - To evaluate the long-term impact of therapeutic schemas on recurrence-free overall survival; - To validate the current prognostic scores from a U.S. population on an independent French cohort; - To identify prognostic variables and select those relevant to the establishment and evaluation of a new score from our database to reflect new biological data (Chevallier and Sataloff scores and molecular classification); - To compare the prognostic qualities of the new score to the U.S. score; - To conduct an external validation of these scores (through collaboration with the Institut Gustave Roussy team in Villejuif and the Institute Bergonie team in Bordeaux); - To isolate genetic (constitutional), genomic (tumour) or immunohistological factors with predictive power for treatment response and prognosis.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="1990-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Bourgogne Franche-Comté</geogCover>
      <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 clusion="I">Patients with breast cancer receiving neoadjuvant chemotherapy; - patient's written consent.                    </universe>
      <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>&lt; 500 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>465</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <restrctn>Data may be used by academic teams. Data may not be used by industrial teams</restrctn>
      <conditions>Data may be used by academic teams Access for biological portion of study carried out in INSERM Unit U866 (Prof. Eric Solary, Dr. Ghiringhelli) in Dijon and INSERM Unit 645 in Besançon Data may not be used by industrial teams</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
