{"doc_desc":{"title":"Etude des facteurs de risque m\u00e9taboliques et environnementaux de carcinome h\u00e9patocellulaire chez les malades atteints de cirrhose","idno":"FRESH-PEF9117-fr","producers":[{"name":"Patrick HILLON","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF9117-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"9117"},{"agency":"FReSH","code":"FRESH-PEF9117"}]},"title":"Etude des facteurs de risque m\u00e9taboliques et environnementaux de carcinome h\u00e9patocellulaire chez les malades atteints de cirrhose","alternate_title":"CIRCE"},"study_authorization":{"agency":[{"name":"CPP"}]},"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":"Non"}],"oth_id":[{"name":"\u00e9tude ProSpec (prot\u00e9omique)","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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":"Carcinog\u00e9n\u00e8se"},{"keyword":"patients cirrhotiques"},{"keyword":"HCC."},{"keyword":"nutrition"},{"keyword":"activit\u00e9 physique"},{"keyword":"CHC"}],"topics":[{"topic":"Oncologie","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":"H\u00e9patologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/27c456a1-051a-42f6-b52a-3beff0487da7"}]},{"topic":"D\u00e9terminants environnementaux : Climat","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"}],"purpose":"Peu de donn\u00e9es sont disponibles sur les m\u00e9canismes de la carcinog\u00e9n\u00e8se chez les patients cirrhotiques et ses facteurs de risque. La pr\u00e9sente \u00e9tude cas-t\u00e9moins clinique, biochimique et mol\u00e9culaire permettra de comprendre le r\u00f4le de la nutrition, de l'activit\u00e9 physique, du syndrome m\u00e9tabolique et des lipides (\u00e9tude CiRCE Lip's) dans le d\u00e9veloppement d'un carcinome h\u00e9patocelullaire (CHC), et ce quelque soit l'\u00e9tiologie de la cirrhose. Cela pourra permettre d'ouvrir de nouvelles perspectives dans la pr\u00e9vention du CHC par le conseil di\u00e9t\u00e9tique et la th\u00e9rapeutique du syndrome m\u00e9tabolique, d'identifier des marqueurs pr\u00e9dictifs du CHC chez les patients cirrhotiques (\u00e9tude CiRCE ProSpec) et de nouvelles cibles th\u00e9rapeutiques dans le traitement de ce cancer au pronostic redoutable.","abstract":"","coll_dates":[{"start":"2008-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\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\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" \u00e2ge sup\u00e9rieur ou \u00e9gal \u00e0 35 ans - consentement \u00e9clair\u00e9  Patients cirrhotiques cas: - patients atteints de carcinome h\u00e9patocellulaire \u00e0 partir d'une cirrhose, quelque soit la cause de la cirrhose - crit\u00e8re de diagnostic du CHC : (Association Europ\u00e9enne pour l'Etude du Foie (EASL) Pour les l\u00e9sions focales h\u00e9patiques de diam\u00e8tre sup\u00e9rieure ou \u00e9gale \u00e0 2 cm :        - alpha-f\u00e9toprot\u00e9ine (AFP) inf\u00e9rieure \u00e0 400 ng\\\/ml; les nodules doivent \u00eatre identifi\u00e9s par au moins deux examens morphologiques avec hypervascularisation art\u00e9rielle dans l'une des modalit\u00e9s d'imagerie (\u00e9chographie abdominale, angiographie, tomodensitom\u00e9trie ou IRM)        - AFP sup\u00e9rieur \u00e0 400 ng\\\/ml; l\u00e9sion mise en \u00e9vidence dans l'une des modalit\u00e9s d'imagerie  Pour les l\u00e9sions focales h\u00e9patiques de diam\u00e8tre inf\u00e9rieur \u00e0 2 cm :        - de 1 \u00e0 2 cm de diam\u00e8tre : utilisation d'une biopsie d'aspiration \u00e0 l'aiguille fine        - moins d'1 cm : \u00e9chographie abdominale tous les 3 mois jusqu'\u00e0 ce que la l\u00e9sion soit plus grande que 1 cm et que la biopsie devienne ainsi possible. Ces cas seront inclus apr\u00e8s confirmation du diagnostic.   Patients cirrhotiques contr\u00f4les : - cirrhose confirm\u00e9e histologiquement par biopsie du foie ou en l'absence de biopsie             chez les patients sans thrombose veineuse \u00e0 l'imagerie Doppler, sur la pr\u00e9sence d'hypertension veineuse confirm\u00e9e par mesures biologiques, morphologiques, de pression veineuse h\u00e9patique ou endoscopie des voies digestives hautes             chez les patients avec thrombose veineuse, sur la pr\u00e9sence d'hypertension veineuse associ\u00e9e \u00e0 des signes cliniques ou morphologiques de cirrhose - signes biologiques d'insuffisance h\u00e9patique - absence de CHC \u00e0 l'inclusion via des examens d'imagerie   \",\n    \"clusion_E\": \"Autre cancer - Infection VIH - Maladie psychiatrique ou somatique majeure incompatible avec l'inclusion dans une \u00e9tude  1179 malades cirrhotiques avec (436 cas) ou sans (743 t\u00e9moins) CHC on \u00e9t\u00e9 inclus dans l'\u00e9tude CiRCE\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1179 :- 436 cas\/cases ou sans - 743 t\u00e9moins\/controls"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Etude cas-t\u00e9moins"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"18-06-2014","lastUpdatedAuto":null,"lastUpdatedManual":"12-05-2015","isContributorPI":"Non","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":"Oui"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Non","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":"Non"},"geographicalCoverage":{"geoDetail":"Besan\u00e7on, Dijon, Metz, Reims, Strasbourg, Vand\u0153uvre-l\u00e8s-Nancy."},"dataTypes":{"clinicalDataDetails":"--","biologicalDataDetails":"Dosage de la vitamine B12 et des folates.","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}