{"doc_desc":{"title":"Case-Control Study on Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients","idno":"FRESH-PEF9117-en","producers":[{"name":"Patrick HILLON","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF9117-en","IDno":{"metadata_no":[{"agency":"PEF","code":"9117"},{"agency":"FReSH","code":"FRESH-PEF9117"}]},"title":"Case-Control Study on Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients","alternate_title":"CIRCE"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Patrick;HILLON","PILabo":"INSERM \/ EPICAD UMR 1231 Dijon","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"050314041","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"200716508T","role":"labo id"}],"email":"","isContact":"No"}],"oth_id":[{"name":"ProSpec study (proteomics)","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0377z4z10","role":"sponsor id"},{"title":"SIREN","uri":"262100076","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0377z4z10"},{"title":"SIREN","uri":"262100076"}]}]},"distribution_statement":{"contact":[{"name":"Vanessa;COTTET","email":"vanessa.cottet@u-bourgogne.fr","type":"contact","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"carcinogenesis"},{"keyword":"cirrhosis"},{"keyword":"HCC"},{"keyword":"nutrition"},{"keyword":"physical activity"}],"topics":[{"topic":"Oncology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D008495"}]},{"topic":"Hepatology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/27c456a1-051a-42f6-b52a-3beff0487da7"}]},{"topic":"Environmental determinants: Climate","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"}],"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":"","coll_dates":[{"start":"2008-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"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.    \",\n    \"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.\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1,179: - 436 cas\/cases or without - 743 t\u00e9moins\/controls"},"method_notes":"Observational Study","study_class":"Completed study","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Case-control study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the scientist in charge for further information.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"18-06-2014","lastUpdatedAuto":null,"lastUpdatedManual":"12-05-2015","isContributorPI":"No","contributorName":"Vanessa COTTET","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"No","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Besan\u00e7on, Dijon, Metz, Reims, Strasbourg and Vand\u0153uvre-l\u00e8s-Nancy."},"dataTypes":{"clinicalDataDetails":"--","biologicalDataDetails":"Dosage of vitamin B12 and folates.","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}