{"doc_desc":{"title":"Cohorte d'enfants atteints d'aphtes oraux r\u00e9currents: diagnostic pr\u00e9coce de la maladie de Behcet","idno":"FRESH-PEF60194-fr","producers":[{"name":"Isabelle KONE-PAUT","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60194-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60194"},{"agency":"FReSH","code":"FRESH-PEF60194"}]},"title":"Cohorte d'enfants atteints d'aphtes oraux r\u00e9currents: diagnostic pr\u00e9coce de la maladie de Behcet","alternate_title":"PED-BD"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Martha;DARCE-BELLO","PILabo":"CENTRE NATIONAL DE REFERENCE DES MALADIES AUTO-INFLAMMATOIRES. RHEUMATOLOGIE PEDIATRIQUE. SERVICE DE PEDIATRIE GENERALE. CENTRE NATIONAL DE REFERENCE DES MALADIES AUTO-INFLAMMATOIRES. RHEUMATOLOGIE PEDIATRIQUE. SERVICE DE PEDIATRIE GENERALE.","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"069816204","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"martha.darce@aphp.fr","isContact":"Oui"},{"type":"investigator","name":"Isabelle;KONE-PAUT","PILabo":"CENTRE NATIONAL DE REFERENCE DES MALADIES AUTO-INFLAMMATOIRES. RHEUMATOLOGIE PEDIATRIQUE. SERVICE DE PEDIATRIE GENERALE. CHU BICETRE","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0001-8939-5763","role":"pi id"},{"title":"IdRef","uri":"076164551","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"isabelle.kone-paut@aphp.fr","isContact":"Oui"},{"type":"investigator","name":"Tu-Anh;TRAN","PILabo":"CENTRE NATIONAL DE REFERENCE DES MALADIES AUTO-INFLAMMATOIRES. RHEUMATOLOGIE PEDIATRIQUE. SERVICE DE PEDIATRIE GENERALE. CHU BICETRE","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"129482692","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"tu.anh.tran@chu-nimes.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14"},{"title":"SIREN","uri":"267500452"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Martha;DARCE-BELLO","email":"martha.darce@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Isabelle;KONE-PAUT","email":"isabelle.kone-paut@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Tu-Anh;TRAN","email":"tu.anh.tran@chu-nimes.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Recurrent oral aphthosis (ROA)"},{"keyword":"sympt\u00f4mes"},{"keyword":"genital ulceration (GU)"},{"keyword":"erythema nodosum"},{"keyword":"folliculitis"},{"keyword":"pustulous\/acneiform lesions"},{"keyword":"positive pathergy test"},{"keyword":"uveitis"},{"keyword":"venous\/arterial thrombosis"},{"keyword":"Maladie de Behcet"},{"keyword":"histoire familiale"}],"topics":[{"topic":"M\u00e9decine interne","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/0d45044a-74d5-4bd7-b920-b92af3388576"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f0844378-9f30-4873-b19b-5bff8c184a36"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D007388"}]},{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"D\u00e9finir des crit\u00e8res de diagnostic pr\u00e9coce de la maladie de Beh\u00e7et chez les patients de moins de 16 ans.","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2012-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Royaume-Uni","abbreviation":"gb","extLink":{"vocab":"ISO","vocabURI":"gb"}},{"name":"Italie","abbreviation":"it","extLink":{"vocab":"ISO","vocabURI":"it"}},{"name":"Suisse","abbreviation":"ch","extLink":{"vocab":"ISO","vocabURI":"ch"}},{"name":"Allemagne","abbreviation":"de","extLink":{"vocab":"ISO","vocabURI":"de"}},{"name":"Japon","abbreviation":"jp","extLink":{"vocab":"ISO","vocabURI":"jp"}},{"name":"Arabie saoudite","abbreviation":"sa","extLink":{"vocab":"ISO","vocabURI":"sa"}},{"name":"Iran, r\u00e9publique islamique d'","abbreviation":"ir","extLink":{"vocab":"ISO","vocabURI":"ir"}},{"name":"Turquie","abbreviation":"tr","extLink":{"vocab":"ISO","vocabURI":"tr"}},{"name":"Egypte","abbreviation":"eg","extLink":{"vocab":"ISO","vocabURI":"eg"}},{"name":"Maroc","abbreviation":"ma","extLink":{"vocab":"ISO","vocabURI":"ma"}}],"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\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Recurrent oral aphthosis (ROA) associ\u00e9e \u00e0 au moins un des ces sympt\u00f4mes: genital ulceration (GU), erythema nodosum, folliculitis, pustulous\\\/acneiform lesions, positive pathergy test, uveitis, venous\\\/arterial thrombosis, family history de Maladie de Behcet\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","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 et apr\u00e8s la saisie des donn\u00e9es informatiques Gestion des donn\u00e9es manquantes : Retour au dossier source,Retour vers le patient,Retour vers un tier Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi ? Oui Relance des sujets pour r\u00e9aliser les visites de suivi ? Oui Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es (Ecrite)']"}},"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":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"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":"< 500 individus","response_rate":"110"},"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 par des \u00e9quipes acad\u00e9miques ; Utilisation des donn\u00e9es par des industriels \u00e0 d\u00e9terminer.","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"08-08-2014","isContributorPI":"Non","contributorName":"Isabelle KONE-PAUT","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=PED-BD"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"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":"Entretiens : saisie manuelle \u00e0 partir d\u2019un questionnaire papier.Examens cliniques : saisie manuscrite.Examens biologiques : saisie manuscrite.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"32 centres : France, Royaume-Uni, Italie, Suisse, Allemagne, Japon, Arabie-Saoudite, Iran, Turquie, Egypte et Maroc."},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi tous les ans.","biologicalDataDetails":"","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}