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<docDscr>
  <citation>
    <titlStmt>
      <titl>Observational, retrospective study exploring RAS mutation tests practices in patients with metastatic colorectal cancer in 2014</titl>
      <IDNo>FRESH-PEF73329-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="MERCK SANTE" role="">Juliette LONGIN</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Observational, retrospective study exploring RAS mutation tests practices in patients with metastatic colorectal cancer in 2014            </titl>
      <altTitl>
                    Flash-RAS                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73329-en            </IDNo>
      <IDNo agency="PEF">
                    73329                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73329                </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>
                    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>
      <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="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    RAS mutation tests</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">To assess the RAS (KRAS and NRAS exons 2,3 and 4) mutation screening test request and realisation rates in patients with a recent diagnosis of metastatic colorectal cancer. Secondary objectives: - To describe changes in the KRAS (exon 2) mutation test request rate between 2011 and 2014; - To describe the reasons for requesting/not requesting and performing/not performing these tests as a function of physician and patient profiles - To describe and to analyse the impact of KRAS (exons 2,3 and 4) and NRAS (exons 2.3 and 4) results, the anatomopathology department availability to provide the tests, and the BRAF result, on therapeutic decision-making or changes in ongoing treatment; - To describe and analyse clinical characteristics of patients and treatments planned and received as first-line therapy of metastatic disease; - To describe the laboratory test method, the type of mutation request (if available) and the method and route by which the result was communicated to the physicians (result report); - To describe and to analyse the time to receipt the KRAS and NRAS results, the process (who ordered the test and when) and the therapeutic approach chosen during this period</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2014-01-01"/>
      <collDate event="end" date="2014-12-31"/>
      <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">To obtain the best possible representativeness while limiting bias, the physician had to screen consecutive patients followed for metastatic colorectal cancer and who had to satisfy the following criteria: - patients 18 years of age or older, - patients with metastatic colorectal cancer histologically-confirmed after march 2014 (date the NRAS tests become available in French centers), - patients seen by the physician between June 15th , 2014 and September 30th, 2014 who have already started first-line treatment, during that time interval, for mCRC - patients in whom first-line therapy of metastatic disease had been already initiated between March 1st, 2014 and June 30th, 2014 - patients seen in a routine visit during the official 15-week screening period of the study                    </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>&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>N= 375 patients, included by 104 physicians</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>
