{"doc_desc":{"producers":[{"name":"Sonia GUEGUEN","affiliation":"SORBONNE UNIVERSITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74149-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74149"},{"agency":"FReSH","code":"FRESH-PEF74149"}]},"title":"Cohorte d\u2019adultes et d\u2019enfants avec maladie de Still (RaDiCo-ACOSTILL)","alternate_title":"RaDiCo-ACOSTILL"},"study_authorization":{"agency":[{"name":"CPP"},{"name":"CESREES"}]},"authoring_entity":[{"name":"Bruno;FAUTREL","firstname":"Bruno","lastname":"FAUTREL","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"uri":"0000-0001-8845-4274","role":"pi id","title":"ORCID"},{"uri":"061407364","role":"pi id","title":"IdRef"}],"email":"bruno.fautrel@aphp.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"National Institute of Health and Medical Research (Inserm) \/ UMR S 1136","isContact":true},{"name":"Sophie;GEORGIN-LAVIALLE","firstname":"Sophie","lastname":"GEORGIN-LAVIALLE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"uri":"0000-0001-6668-8854","role":"pi id","title":"ORCID"},{"uri":"111766311","role":"pi id","title":"IdRef"}],"email":"sophie.georgin-lavialle@aphp.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"National Institute of Health and Medical Research (Inserm) \/ UMRS 938","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]}]},"distribution_statement":{"contact":[{"name":"Bruno;FAUTREL","lastname":"FAUTREL","firstname":"Bruno","type":"contact","email":"bruno.fautrel@aphp.fr","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"}]},{"name":"Sophie;GEORGIN-LAVIALLE","lastname":"GEORGIN-LAVIALLE","firstname":"Sophie","type":"contact","email":"sophie.georgin-lavialle@aphp.fr","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":[],"topics":[{"topic":"M\u00e9decine interne","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/0d45044a-74d5-4bd7-b920-b92af3388576 | http:\/\/data.europa.eu\/8mn\/euroscivoc\/f0844378-9f30-4873-b19b-5bff8c184a36"},{"title":"MeSH","uri":"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":"D010372"}]},{"topic":"Rhumatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bfb0bafd-7894-45ba-84fc-ddab5fd6c537"},{"title":"MeSH","uri":"D012219"}]},{"topic":"Maladie de Still de l'adulte","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/549009522","title":"CIM-11"}]}],"purpose":"L\u2019objectif principal est de d\u00e9crire l\u2019histoire naturelle de la maladie dans les populations adultes et p\u00e9diatriques","abstract":"","coll_dates":[{"start":"2017-01-01","end":"2027-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Masculin\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"F\u00e9minin\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D007231\"}},{\"value\":\"Nourrisson (28j \u00e0 2 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D007223\"}},{\"value\":\"Petite enfance (2 \u00e0 5 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D002675\"}},{\"value\":\"Enfance (6 \u00e0 12 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D002648\"}},{\"value\":\"Adolescence (13 \u00e0 18 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000293\"}},{\"value\":\"Adulte (19 \u00e0 24 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adulte (25 \u00e0 44 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Adulte (45 \u00e0 64 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}},{\"value\":\"Grand \u00e2ge (80 ans et plus)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000369\"}}],\"level_type_clusion_I\":\"Patients\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Les crit\u00e8res d\u2019inclusion de la cohorte RaDiCo-ACOSTILL sont les suivants : - Patients \u00e2g\u00e9s de plus de 16 ans (\u00e2ge >16 ans) r\u00e9pondant aux crit\u00e8res diagnostics de Yamaguchi ou crit\u00e8res Fautrel - Patients \u00e2g\u00e9s de 16 ans au plus (\u00e2ge \u226416 ans) remplissant les crit\u00e8res 2001 pour ILAR forme syst\u00e9mique d'arthrite juv\u00e9nile idiopathique  - Ayant sign\u00e9 un consentement pour participer \u00e0 la cohorte et \u00e0 la collecte de donn\u00e9es cliniques et biologiques ; conform\u00e9ment \u00e0 la r\u00e9glementation, pour les patients  d\u00e9c\u00e9d\u00e9s mineurs ou majeurs prot\u00e9g\u00e9s, la non-opposition des repr\u00e9sentants l\u00e9gaux sera recherch\u00e9e.  - Affili\u00e9s au r\u00e9gime de la s\u00e9curit\u00e9 sociale \",\"clusion_E\":\"Autre cause de fi\u00e8vre r\u00e9currente infectieuse (comme la tuberculose, la toxoplasmose, des abc\u00e8s profonds, des viroses, des sepsis) ou tumorale (comme des lymphomes)  - Autres rhumatismes inflammatoires d\u00e9finis tels que la polyarthrite rhumato\u00efde, le rhumatisme psoriasique, les spondylarthropathies - Maladie inflammatoire autoimmune (lupus syst\u00e9mique \u00e9ryth\u00e9mateux), granulomatose (sarco\u00efdose, syndrome de Blau), les vascularites (maladie de Beh\u00e7et, pan art\u00e9rite noueuse), les polymyosites et dermatomyosites - Syndromes auto inflammatoires bien d\u00e9finis avec mutations non ambig\u00fces, comme la fi\u00e8vre m\u00e9diterran\u00e9enne familiale, les cryopyrinopathies, le TRAPS, le d\u00e9ficit en  m\u00e9valonate kinase - Syndromes d\u2019activation macrophagiques d\u2019origine g\u00e9n\u00e9tique connus  \u2013 Patients dans l\u2019incapacit\u00e9 de comprendre la notice d\u2019information et de signer le formulaire de consentement \u00e9clair\u00e9 - Patients non affili\u00e9s au r\u00e9gime de la s\u00e9curit\u00e9 sociale\"}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques (hors biologiques)','Donn\u00e9es paracliniques (hors biologiques) : Imagerie','Donn\u00e9es biologiques','Donn\u00e9es de sant\u00e9 rapport\u00e9es par les participants de l'\u00e9tude']","quality_statement":{"standards":[{"name":"['HPO, ICD10, Snomed CT, Codes Orpha et ORDO, Dictionnaire des m\u00e9dicaments (DCIs)']","committee":"","governance":""}],"other_quality_statement":"['Plan de Data Management et Plan de Validation des Donn\u00e9es. Management des donn\u00e9es en continu (r\u00e8gles de contr\u00f4le automatiques et syst\u00e8me de queries)']"}},"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\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue\r\nAutres"}]},"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\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"422"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Registre de morbidit\u00e9"]}]},"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\"}]}","notes":""},"dataset_use":{"restrictions":"","conditions":"Les demandes d'acc\u00e8s aux donn\u00e9es RaDiCo-ACOSTILL (agr\u00e9g\u00e9es ou individuelles) seront examin\u00e9es par le Comit\u00e9 Scientifique suite \u00e0 la soumission d'un r\u00e9sum\u00e9 de Projet de Recherche Sp\u00e9cifique (PRS), tel que d\u00e9fini dans la Charte d'acc\u00e8s aux ressources.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"Import\u00e9e","creationDate":"28-02-2024","lastUpdatedManual":"03-12-2024","isContributorPI":"","contributorName":"Sonia GUEGUEN","contributorAffiliation":"SORBONNE UNIVERSITE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":true},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"eCRF en acc\u00e8s s\u00e9curis\u00e9 web, cloud s\u00e9curis\u00e9 et h\u00e9bergement HADS","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Les principales variables collect\u00e9es sont : la d\u00e9mographie, les ant\u00e9c\u00e9dents familiaux et m\u00e9dicaux, les donn\u00e9es socio-\u00e9conomiques, cliniques, et biologiques, les signes cliniques, sympt\u00f4mes ainsi que les traitements sp\u00e9cifiques \u00e0 la maladie, et les auto-questionnaires de qualit\u00e9s de vie.","biologicalDataDetails":"Don\u00e9es biochimiques, h\u00e9matologiques et immunologiques","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}