{"doc_desc":{"title":"REGISTRE DES CYTOPENIES AUTO-IMMUNES EN FRANCE","idno":"FRESH-PEF5294-fr","producers":[{"name":"Guillaume MOULIS","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5294-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5294"},{"agency":"FReSH","code":"FRESH-PEF5294"}]},"title":"REGISTRE DES CYTOPENIES AUTO-IMMUNES EN FRANCE","alternate_title":"CARMEN-France"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"authoring_entity":[{"type":"investigator","name":"Guillaume;MOULIS","PILabo":"CHU de Toulouse \/ CIC 1436","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","extlink":[{"title":"ORCID","uri":"0000-0001-9953-4640","role":"pi id"},{"title":"IdRef","uri":"16509396X","role":"pi id"},{"title":"SIREN","uri":"263100125","role":"organisation id"},{"title":"RNSR","uri":"199318008J","role":"labo id"}],"email":"moulis.g@chu-toulouse.fr","isContact":"Oui"}],"oth_id":[{"name":"R\u00e9seau national du centre de r\u00e9f\u00e9rence des cytop\u00e9nies auto-immunes de l'adulte (CeReCAI). European Research Consortium on Immune thrombocytopenia (ERCI)","type":"collaboration"}],"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"},{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/017h5q109","role":"sponsor id"},{"title":"SIREN","uri":"263100125","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/017h5q109"},{"title":"SIREN","uri":"263100125"}]},{"name":"CSL BEHRING S.A.","extlink":[]},{"name":"NOVARTIS PHARMA SAS","extlink":[{"title":"SIREN","uri":"410349070"}]},{"name":"SOCIETE NATIONALE FRANCAISE DE MEDECINE INTERNE (SNFMI)","extlink":[{"title":"SIREN","uri":"316607902"}]}]},"distribution_statement":{"contact":[{"name":"Guillaume;MOULIS","email":"moulis.g@chu-toulouse.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/017h5q109","role":"organisation id","title":"ROR"},{"uri":"263100125","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"cytop\u00e9nies auto-immunes"},{"keyword":"purpura thrombop\u00e9nique immunologique"},{"keyword":"an\u00e9mie h\u00e9molytique auto-immune"},{"keyword":"pharmaco\u00e9pid\u00e9iologie"},{"keyword":"registre"},{"keyword":"\u00e9pid\u00e9miologie"}],"topics":[{"topic":"H\u00e9matologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9239f328-78c9-40a5-a0b9-8e66fd9b6245"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006402"}]},{"topic":"Immunologie m\u00e9dicale","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7a3cf568-46ba-4840-be8f-f22fc030139f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"topic":"Purpura thrombocytop\u00e9nique immun","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/364346400","title":"CIM-11"}]},{"topic":"An\u00e9mie h\u00e9molytique acquise, immune","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1834341306","title":"CIM-11"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autre","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":"D\u00e9crire l\u2019\u00e9pid\u00e9miologie du purpura thrombop\u00e9nique immunologique et de l'an\u00e9mie h\u00e9molytique auto-immune, leur prise en charge, et fournir des RWE sur les traitements de ces maladies en termes d'efficacit\u00e9 et de s\u00e9curit\u00e9","abstract":"","coll_dates":[{"start":"2013-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Grand Est','Nouvelle-Aquitaine','Auvergne Rh\u00f4ne-Alpes','Bourgogne Franche-Comt\u00e9','Bretagne','Centre-Val de Loire','Ile-de-France','Occitanie','Hauts-de-France','Normandie','Pays de la Loire','Provence - Alpes - C\u00f4te d\\'Azur']","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            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Crit\u00e8re d'inclusion : - \u00e2ge 18 ans et plus - nouveau diagnostic de PTI (depuis 2025, intiaition d'un traitement de maintenance pour un PTI), ou d'AHAI ou d\u00e9but d'un traitement nouvellement commercialis\u00e9 pour PTI ou AHAI - absence d'opposition \u00e0 la collection des donn\u00e9es\",\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']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['remote data quality check sur tous les patients pour une centaines de variables clefs ; monitoring physique sur 10 % de la base dans les centres en 2023-2024']"}},"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"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"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":"[1000-10000[ individus","response_rate":"2832 au 31\/12\/2024"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude en cours","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Registre de morbidit\u00e9"]},{"subject":"follow-up","values":["Suivi par contact avec le participant (t\u00e9l\u00e9phone, e-mail, courrier...)"]}]},"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":"Accord du comit\u00e9 scientifique et du promoteur","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":"03-01-2013","lastUpdatedAuto":null,"lastUpdatedManual":"10-11-2017","isContributorPI":"Non","contributorName":"Guillaume MOULIS","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"article describing the registry, the database and examples of published studies (n>20)","link":"https:\/\/pubmed.ncbi.nlm.nih.gov\/38960844\/"},{"type":"","title":"article descriptif de la base et d'\u00e9tudes r\u00e9alis\u00e9es","link":"http:\/\/epidemiologie-france.aviesan.fr\/voir publication https:\/\/pubmed.ncbi.nlm.nih.gov\/38960844"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Industrie","Industrie","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["","","",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":"Oui"},"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":"Les formulaires de suivi sont remplis par les ARC des centres lors de chaque consultation ou hospitalisation du patient sur une eBDD centralis\u00e9e","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Extension \u00e0 d'autres centres pr\u00e9vue ; exhaustivit\u00e9 des centres dans la r\u00e9gion Occitanie-Ouest (ex-Midi-Pyr\u00e9n\u00e9es)"},"dataTypes":{"clinicalDataDetails":"terrain, maladie, \u00e9v\u00e8nements ; voir publication https:\/\/pubmed.ncbi.nlm.nih.gov\/38960844\/","biologicalDataDetails":"voir publication https:\/\/pubmed.ncbi.nlm.nih.gov\/38960844\/","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}