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<docDscr>
  <citation>
    <titlStmt>
      <titl>COHORT ON HEALTH-RELATED QUALITY OF LIFE IN GYNAECHOLOGIC ONCOLOGY</titl>
      <IDNo>FRESH-PEF8137-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CHU BESANCON (CHU)" role="">Rajeev RAMANAH</producer>
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  <citation>
    <titlStmt>
      <titl>
                COHORT ON HEALTH-RELATED QUALITY OF LIFE IN GYNAECHOLOGIC ONCOLOGY            </titl>
      <altTitl>
                    GYNEQOL                </altTitl>
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                FRESH-PEF8137-en            </IDNo>
      <IDNo agency="PEF">
                    8137                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF8137                </IDNo>
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    <rspStmt>
      <AuthEnty>
                    Charles COUTANT                                                                                                                            </AuthEnty>
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      <AuthEnty>
                    Sandrine DABAKUYO                                                                                                                            </AuthEnty>
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      <AuthEnty>
                    Rajeev RAMANAH                                                                                                                            </AuthEnty>
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      <AuthEnty>
                    Sophie PAGET-BAILLY                                                                                                                            </AuthEnty>
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      <AuthEnty>
                    Elsa KALBACHER                                                                                                                            </AuthEnty>
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    <prodStmt>
      <producer role="sponsor">
                                            UNIVERSITE MARIE ET LOUIS PASTEUR (UMLP)                    
                                    </producer>
      <producer role="sponsor">
                                            CHU BESANCON (CHU)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
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      <contact affiliation="CENTR GEORGES FRANCOIS LECLERC" email="ccoutant@cgfl.fr">
                    Charles;COUTANT
                                            <ExtLink title="ROR" URI="https://ror.org/00pjqzf38" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="778204271" role="organisation id"/>
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                    Sandrine;DABAKUYO
                                            <ExtLink title="ROR" URI="https://ror.org/00pjqzf38" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="778204271" role="organisation id"/>
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                    Rajeev;RAMANAH
                                            <ExtLink title="ROR" URI="https://ror.org/0084te143" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="262501760" role="organisation id"/>
                                    </contact>
      <contact affiliation="CHU BESANCON (CHU)" email="spaget@chu-besancon.fr">
                    Sophie;PAGET-BAILLY
                                            <ExtLink title="ROR" URI="https://ror.org/0084te143" role="organisation id"/>
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                                    </contact>
      <contact affiliation="CHU BESANCON (CHU)" email="elsa.kalbacher@clermont.unicancer.fr">
                    Elsa;KALBACHER
                                            <ExtLink title="ROR" URI="https://ror.org/0084te143" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="262501760" 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="">
                    Endometrial cancer</keyword>
      <keyword vocab="" vocabURI="">
                    cervical cancer</keyword>
      <keyword vocab="" vocabURI="">
                    vulvar cancer</keyword>
      <keyword vocab="" vocabURI="">
                    ovarian cancer</keyword>
      <keyword vocab="" vocabURI="">
                    quality of life</keyword>
      <keyword vocab="" vocabURI="">
                    sexuality</keyword>
      <topcClas vocab="health theme">
                        Gynaecology and obstetrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/7de64596-5b0d-4977-8f98-b982ff2ec17d"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/284ca20c-beb4-4abe-99fa-ef4513358bad"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D006176"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D009774"/>
                                                </topcClas>
      <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 female genital organs                                            </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Environmental determinants: Other                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Environmental determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">• Main objective To study factors (clinical, biological, sociodemographic, behavioural) associated with quality of life (QoL) in real-life situations, in patients with gynecologic cancers, namely endometrial cancer, cervical cancer, vulvar and vaginal cancer and ovarian cancer. • Secondary Objectives To describe patient characteristics at baseline and compare QoL data of cohort patients with European and French data To compare QoL of patients who have undergone surgery for endometrial and cervical cancer according to different surgical approaches: Laparoscopy versus laparotomy Robot-assisted versus conventional laparoscopic surgery To assess QoL over time and for the "long-term" in patients with ovarian cancer, particularly those receiving intraperitoneal perioperatory adjuvant chemotherapy To assess the impact of targeted therapies on the QoL of patients with cervical and ovarian cancer To analyse time up to QoL deterioration in ovarian cancer and to research factors associated with deterioration To determine if QoL is different depending on the histological type of endometrial cancer To compare QoL of patients who have received and have not received adjuvant CT after surgery and radiotherapy for endometrial cancer To evaluate the importance of early palliative care patients in QoL Validation of SAQ sexuality questionnaire in French</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2015-01-01"/>
      <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 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">Selected pelvic cancers are cervical, uterine body, ovarian, vaginal and vulvar cancer, irrespective of histological type and stage: - Follow-up in Franche-Comté and the Georges François Leclerc Centre in Dijon - Age: 18 years and over - good knowledge of French - Able to respond to questionnaires (no major cognitive impairment) - Living in Franche Comté and Burgundy at time of diagnosis - having given signed consent - Covered by Social Security                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services
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>[500-1000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </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>
    <anlyInfo>
      <respRate>---</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Contact the principal investigator</conditions>
    </useStmt>
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    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
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<dataDscr>
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