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<docDscr>
  <citation>
    <titlStmt>
      <titl>Evaluation of a ddPCR technology for the SARS-CoV-2 detection based on different types of samples in cancer patients with suspicion of COVID-19 (symptomatic)</titl>
      <IDNo>FRESH-PEF73849-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="UNICANCER GROUP" role="">Ellen BLANC</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Evaluation of a ddPCR technology for the SARS-CoV-2 detection based on different types of samples in cancer patients with suspicion of COVID-19 (symptomatic)            </titl>
      <altTitl>
                    ONCOVID-21                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73849-en            </IDNo>
      <IDNo agency="PEF">
                    73849                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73849                </IDNo>
      <IDNo agency="NCT">
                    NCT04510454                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Bénédicte MASTROIANNI                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE LEON BERARD">
        <ExtLink title="ROR" URI="https://ror.org/01cmnjq37" role="organisation id"/>
        <ExtLink title="SIREN" URI="779924133" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE LEON BERARD                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </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="">
                    SARSCOV2</keyword>
      <keyword vocab="" vocabURI="">
                    CANCER</keyword>
      <keyword vocab="" vocabURI="">
                    ddPCR</keyword>
      <keyword vocab="" vocabURI="">
                    RT-qPCR</keyword>
      <keyword vocab="" vocabURI="">
                    SEROLOGICAL ASSAYS</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="health theme">
                        Infectious disease medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D055552"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Neoplasms                                            </topcClas>
      <topcClas vocab="cim-11">
                        COVID-19                                            </topcClas>
    </subject>
    <abstract contentType="purpose">To determine the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection using an IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA IgG) as gold/reference standard (FDA validated commercial serologic test). The primary endpoint will be the sensibility of the ddPCR assay for SARS-CoV-2 detection based on nasopharyngeal samples.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2020-01-01"/>
      <collDate event="end" date="2021-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe clusion="I">1. Age ≥ 18 years on the day of signing informed consent. 2. Confirmed diagnosis of any type of solid or hematologic tumor. 3. Ongoing anticancer treatment at the time of inclusion or within the last 3 months prior to inclusion (last treatment administration or last loco regional procedure) 4. Suspicion of COVID-19 infection. Patients must not have underwent diagnostic test and/or chest imaging before inclusion. * At least one of the following clinical symptoms: fever (&gt;38°C), dry cough, fatigue, pulmonary involvement (febrile respiratory infection or respiratory difficulties), pharyngalgia, headaches, myalgia, gastrointestinal symptoms including abdominal pain and diarrhea, anosmia and agueusia, radiological signs of pneumonia as described by Shi et al. 5. Covered by a medical/health insurance. 6. Signed and dated informed consent form.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
  </stdyInfo>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 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>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
