{"doc_desc":{"title":"Cohorte d'adultes d'\u00e2ge m\u00fbr : SUppl\u00e9mentation en VItamines et Min\u00e9raux AntioXydants","idno":"FRESH-PEF3925-fr","producers":[{"name":"Serge HERCBERG","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3925-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3925"},{"agency":"FReSH","code":"FRESH-PEF3925"}]},"title":"Cohorte d'adultes d'\u00e2ge m\u00fbr : SUppl\u00e9mentation en VItamines et Min\u00e9raux AntioXydants","alternate_title":"SU.VI.MAX"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Serge;HERCBERG","PILabo":"INSERM \/ Unit\u00e9 de Recherche en Epid\u00e9miologie Nutritionnelle (UREN), U557 Inserm \/ U1125 Inra \/ Cnam \/ Universit\u00e9 Paris 13 (Sorbonne Paris-Cit\u00e9)","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0002-3168-1350","role":"pi id"},{"title":"IdRef","uri":"02858709X","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"201119719R","role":"labo id"}],"email":"s.hercberg@eren.smbh.univ-paris13.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CATALENT PHARMA SOLUTIONS, LLC","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04brn0b16","role":"sponsor id"},{"title":"SIREN","uri":"981349574","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Serge;HERCBERG","email":"s.hercberg@eren.smbh.univ-paris13.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":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"d\u00e9c\u00e8s"},{"keyword":"pr\u00e9vention"}],"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":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"Etablir la nature causale du lien entre un apport nutriments antioxydants et le risque de cancer, de cardiopathie isch\u00e9mique ou la mortalit\u00e9. Mieux conna\u00eetre les relations qu'il existe entre l'alimentation et la sant\u00e9, en constituant une grande banque de donn\u00e9es sur la consommation alimentaire et l'\u00e9tat de sant\u00e9 des fran\u00e7ais.","abstract":"","coll_dates":[{"start":"1994-01-01","end":"2003-01-01"}],"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 (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\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\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Hommes de 45 \u00e0 60 ans et femmes de 35 \u00e0 60 ans\",\n    \"clusion_E\": \"\"\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":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment de la saisie des donn\u00e9es informatiques Gestion des donn\u00e9es manquantes : retour vers le patient ou retour vers un tiers Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi.Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Base de population \u00e0 finalit\u00e9 statistique']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Recording\",\"vocab\":\"CESSDA\"},\"value\":\"Recording (audio, video, electrophysiological, imaging)Enregistrement (audio, vid\u00e9o, \u00e9lectrophysiologique, imagerie)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[10000-20000[ individus","response_rate":"12741 subjects included, 12177 subjects still alive in 2003"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"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":"Utilisation possible des donn\u00e9es pour d'autres recherches. Evaluation de la pertinence du projet, de son financement et sa faisabilit\u00e9. Mise en place d'une convention pour les industriels.","conditions":"","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":"17-12-2013","lastUpdatedAuto":null,"lastUpdatedManual":"31-12-2013","isContributorPI":"Non","contributorName":"Serge HERCBERG","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/www.hal.inserm.fr\/SUVIMAX"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"- Auto-questionnaire sant\u00e9 (annuel): tous les \u00e9v\u00e8nements de sant\u00e9, la \"consommation m\u00e9dicale et de soins\", l'observance et la morbidit\u00e9 ont \u00e9t\u00e9 recueillies, \u00e9chelle qualit\u00e9 de vie SF36- Auto-questionnaire alimentaire (6 fois par an): enregistrement alimentation qualitatif et quantitatif, lieux de prise alimentaire, quantit\u00e9 consomm\u00e9e, mode de pr\u00e9paration, origine des aliments, marques, infos utiles pour \u00e9valuer avec pr\u00e9cision les apports nutritionnels des volontaires- Auto-questionnaire de fr\u00e9quence alimentaire (d\u00e9but et fin d'\u00e9tude): habitudes alimentaires en g\u00e9n\u00e9ral, semi-quantitatif- Auto-questionnaire d'activit\u00e9 physique.- Recueil de donn\u00e9es cliniques (\u00e0 l'inclusion puis tous les 2 ans): examen clinique complet, ECG, TA, Frottis cervico-vaginal (femmes qui ne l'avaient pas eu dans l'ann\u00e9e), recherche de sang dans les selles (SJ sup\u00e9rieur \u00e0 45 ans), mesure de l'acuit\u00e9 visuelle, mesures anthropom\u00e9triques, mammographie (femmes sup\u00e9rieur \u00e0 50 ans)Auto-questionnaire : saisie directe Examens cliniques : saisie manuelle avec double saisie Examens biologiques : saisie directe","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi tous les deux ans.Informations recueillies lors de l'examen clinique : examen clinique complet, ECG, TA, frottis cervico-vaginal (femmes qui ne l'avaient pas eu dans l'ann\u00e9e), recherche de sang dans les selles (SJ sup\u00e9rieur \u00e0 45 ans), mesure de l'acuit\u00e9 visuelle, mesures anthropom\u00e9triques, mammographie (femmes sup\u00e9rieur \u00e0 50 ans).","biologicalDataDetails":"sang, selles, urines","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}