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<docDscr>
  <citation>
    <titlStmt>
      <titl>Case-Control Study on Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients</titl>
      <IDNo>FRESH-PEF9117-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" role="">Patrick HILLON</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Case-Control Study on Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients            </titl>
      <altTitl>
                    CIRCE                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF9117-en            </IDNo>
      <IDNo agency="PEF">
                    9117                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF9117                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Patrick HILLON                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)">
        <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
        <ExtLink title="SIREN" URI="180036048" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="ProSpec study (proteomics)" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" email="vanessa.cottet@u-bourgogne.fr">
                    Vanessa;COTTET
                                            <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="180036048" 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="">
                    carcinogenesis</keyword>
      <keyword vocab="" vocabURI="">
                    cirrhosis</keyword>
      <keyword vocab="" vocabURI="">
                    HCC</keyword>
      <keyword vocab="" vocabURI="">
                    nutrition</keyword>
      <keyword vocab="" vocabURI="">
                    physical activity</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">
                        Hepatology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/27c456a1-051a-42f6-b52a-3beff0487da7"/>
                                                </topcClas>
      <topcClas vocab="health determinant">
                        Environmental determinants: Climate                    </topcClas>
      <topcClas vocab="health determinant">
                        Environmental determinants: Other                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Eating habits                    </topcClas>
      <topcClas vocab="health determinant">
                        Environmental determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants: Employment                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Little data are available on carcinogenesis mechanisms in cirrhotic patients and associated risk factors. This clinical, biochemical and molecular case-control study may be relevant to the understanding of nutrition, physical activity, metabolic syndrome and lipids (CiRCE Lip's study) in the development of hepatocellular carcinoma (HCC), regardless of the aetiology of the underlying cirrhosis. It will open new perspectives in HCC prevention through dietary counselling and metabolic syndrome therapeutics and identify predictive HCC markers in cirrhotic patients (CiRCE ProSpec study), as well as new therapeutic targets for the treatment of cancer with challenging prognosis.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2008-01-01"/>
      <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">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 clusion="I">Aged 35 or over; - Informed consent.  Cirrhotic cases: - Patients with hepatocellular carcinoma cases from liver cirrhosis, regardless of the cause of the cirrhosis. - Criteria for hepatocellular carcinoma diagnosis: European Association for Study of the Liver (EASL); Focal hepatic lesions greater or equal to 2 cm in diameter: - Alpha-fetoprotein (AFP) below 400 ng/ml: nodules must be identified by at least two morphological examinations (abdominal ultrasound, angiography, CT or MRI); - AFP over 400 ng/ml: lesion seen in a single imaging procedure;   Focal hepatic lesions less 2 cm in diameter: - Lesions 1 to 2 cm in diameter: use of fine-needle aspiration with biopsy; - Lesions less than 1 cm: serial abdominal ultrasound every 3 months until the lesion exceeds 1 cm in size so that biopsy becomes possible. These cases will be included at time of diagnosis.  Cirrhotic control patients: - Histological confirmation by liver biopsy or in the absence of biopsy: - In patients with no portal thrombosis at Doppler imaging, on the presence of portal hypertension confirmed by biological, morphological, hepatic venous pressure measurements or upper endoscopy. - In patients with portal thrombosis, on the presence of portal hypertension associated with clinical or morphological signs of cirrhosis. - Biological signs of hepatocellular failure. - Lack of HCC at baseline through imaging examinations.                        </universe>
      <universe clusion="E">Other cancer; - HIV infection; - Major somatic or psychiatric illness not compatible for inclusion in the study.1,179 cirrhotic patients with (436 cases) or without (743 controls) HCC were enrolled in the CiRCE study.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity</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>[1000-10000[ 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>
    <notes subject="observational study method">
                        Case-control study                    </notes>
    <anlyInfo>
      <respRate>1,179: - 436 cas/cases or without - 743 témoins/controls</respRate>
    </anlyInfo>
    <stdyClas>Completed study</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Contact the scientist in charge for further information.</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
