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<docDscr>
  <citation>
    <titlStmt>
      <titl>Retrospective observational study taking an inventory of the KRAS test in 2011 in patients with metastatic colorectal cancer having recently started a first-line treatment</titl>
      <IDNo>FRESH-PEF73327-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="MERCK SANTE" role="">Juliette LONGIN</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Retrospective observational study taking an inventory of the KRAS test in 2011 in patients with metastatic colorectal cancer having recently started a first-line treatment            </titl>
      <altTitl>
                    Flash-KRAS                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73327-en            </IDNo>
      <IDNo agency="PEF">
                    73327                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73327                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Pierre LAURENT-PUIG                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)">
        <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
        <ExtLink title="SIREN" URI="267500452" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Astrid LIEVRE                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)">
        <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
        <ExtLink title="SIREN" URI="267500452" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Michel GUIU                                                                                </AuthEnty>
      <AuthEnty affiliation="CENTRE DE PATHOLOGIE DES DOCTEURS ISABELLE BIAL - CELINE LAMBOLAIS - ALEXANDRE NATAF - JEAN PHILIPPE MOMPART, CECILE BOR">
        <ExtLink title="SIREN" URI="315932525" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Jean-Louis MERLIN                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY">
        <ExtLink title="ROR" URI="https://ror.org/016ncsr12" role="organisation id"/>
        <ExtLink title="SIREN" URI="200042166" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Jean-Christophe SABOURIN                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE ROUEN">
        <ExtLink title="ROR" URI="https://ror.org/04cdk4t75" role="organisation id"/>
        <ExtLink title="SIREN" URI="267601680" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Pascal ARTRU                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="HOSPICES CIVILS DE LYON (HCL)">
        <ExtLink title="ROR" URI="https://ror.org/01502ca60" role="organisation id"/>
        <ExtLink title="SIREN" URI="266900273" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Michel DUCREUX                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="INSTITUT GUSTAVE ROUSSY (IGR)">
        <ExtLink title="ROR" URI="https://ror.org/0321g0743" role="organisation id"/>
        <ExtLink title="SIREN" URI="775741101" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Jérôme VIGUIER                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE DE TOURS">
        <ExtLink title="ROR" URI="https://ror.org/02wwzvj46" role="organisation id"/>
        <ExtLink title="SIREN" URI="193708005" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            MERCK SANTE                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            MERCK SANTE                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="" email="">
                    
                                    </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="">
                    Flash-KRAS</keyword>
      <keyword vocab="" vocabURI="">
                    Colorectal cancer</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">
                        Neoplasms                                            </topcClas>
    </subject>
    <abstract contentType="purpose">Evaluate the KRAS test prescription rate in patients starting a first-line treatment for metastatic colorectal cancer. Secondary objectives: - Describe the potential reasons for not prescribing this test - Describe and analyse the clinical characteristics of patients and treatments planned and received in first-line metastatic treatment - Describe and analyse the time frame for obtaining the result of the KRAS test and the channel (who makes the request and when) and the therapeutic attitude adopted during this period - Analyse the impact of the availability of the KRAS test and its result on the therapeutic choice of the physician - Describe the technic used for the analysis, the type of mutation (if available) and the method for reporting the results to the clinicians (report of the results)</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2011-01-01"/>
      <collDate event="end" date="2011-12-31"/>
      <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">Each participating centre had to select the exhaustiveness of the patients seen in consultation during the study period, meeting all of the following criteria:  - Patients aged 18 years or older,  - Patients with histologically proven metastatic colorectal cancer,  - Patients for whom a metastatic first-line treatment was initiated between 01/01/2011 and 27/03/2011,  - Patients seen in consultation during the official 2-week study selection period.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health care consumption and services</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners 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>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>n=538 patients (160 centres)</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
