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<docDscr>
  <citation>
    <titlStmt>
      <titl>Prescription and Utilisation of Low Molecular Weight Heparin (LMWH) in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism (VTE) in Patients With Cancer.</titl>
      <IDNo>FRESH-PEF5615-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="LABORATOIRES LEO (LEO PHARMA)" role="">Nadine MACKENZIE</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Prescription and Utilisation of Low Molecular Weight Heparin (LMWH) in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism (VTE) in Patients With Cancer.            </titl>
      <altTitl>
                    TROPIQUE                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF5615-en            </IDNo>
      <IDNo agency="PEF">
                    5615                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF5615                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Anne LAMBLIN                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="LABORATOIRES LEO (LEO PHARMA)">
        <ExtLink title="ROR" URI="https://ror.org/02wvemr05" role="organisation id"/>
        <ExtLink title="SIREN" URI="572208122" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            LABORATOIRES LEO (LEO PHARMA)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            LABORATOIRES LEO (LEO PHARMA)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="LABORATOIRES LEO (LEO PHARMA)" email="anne.lamblin@leo-pharma.com">
                    Anne;LAMBLIN
                                            <ExtLink title="ROR" URI="https://ror.org/02wvemr05" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="572208122" 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="">
                    Venous thromboembolism</keyword>
      <keyword vocab="" vocabURI="">
                    Cancer</keyword>
      <keyword vocab="" vocabURI="">
                    LMWH</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">
                        Functions of the cardiovascular, haematological, immunological and respiratory systems                                            </topcClas>
      <topcClas vocab="cim-11">
                        Malignant neoplasms of ill-defined or unspecified primary sites                                            </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">To document the prescription and the use of LMWH in usual medical practice in France for the treatment of symptomatic VTE in patients with cancer. To assess the conformity of LMWH usage with national recommendations (www.sor-cancer.com et www.thrombose-cancer.com) for VTE treatment in patients with cancer. To evaluate thromboembolism recurrence, bleeding, thrombocytopenia and death as well as document the reasons for discontinuing treatment. To describe clinical factors associated with LMWH treatment duration and those associated with the occurrence of VTE in patients with cancer. To evaluate anticoagulant treatment perception in cancer patients in order to have a better knowledge of their LMWH treatment satisfaction.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2012-01-01"/>
      <collDate event="end" date="2014-01-01"/>
      <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 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">Men or women aged 18 years or more. Patients who have given oral consent to participate after receiving oral and written information concerning the study. Patients with a solid or liquid tumour confirmed by a histological or cytological examination and receiving anti-cancerous therapy or palliative care. Patients diagnosed with venous thromboembolism (VTE) defined as: - symptomatic proximal or distal deep vein thrombosis (DVP) - confirmed pulmonary embolism (PE) - visceral embolism - thrombosis from a long-term central venous catheter. Patients who have begun curative VTE treatment with LMWH for 7 days or more.                    </universe>
      <universe clusion="E">Patients treated with LMWH for more than 7 days. Patients presenting contraindications to LMWH use confirmed by respective multidisciplinary meetings.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
  </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>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <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>155 (21/03/2013)</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>All requests to be sent to LEO Pharma</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
