{"doc_desc":{"title":"REGISTRY OF AUTOIMMUNE CYTOPENIAS IN FRANCE","idno":"FRESH-PEF5294-en","producers":[{"name":"Guillaume MOULIS","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5294-en","IDno":{"metadata_no":[{"agency":"PEF","code":"5294"},{"agency":"FReSH","code":"FRESH-PEF5294"}]},"title":"REGISTRY OF AUTOIMMUNE CYTOPENIAS IN FRANCE","alternate_title":"CARMEN-France"},"study_authorization":{"agency":[]},"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":"Yes"}],"oth_id":[{"name":"French network of autoimmune cytopenia (CeReCAI). European Research Consortium on ITP (ERCI)","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"immune thromboctyopenia"},{"keyword":"autoimmune hemolytic anemia"},{"keyword":"registry"},{"keyword":"epidemiology"},{"keyword":"pharmacoepidemiology"}],"topics":[{"topic":"Hematology","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":"Clinical immunology","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":"Immune thrombocytopenic purpura","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/364346400","title":"CIM-11"}]},{"topic":"Acquired haemolytic anaemia, immune","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1834341306","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"}],"purpose":"To describe the epidemiology of immune thrombocytopenic purpura (ITP) and of autoimmune hemolytic anemia (AIHA), assess their mangement and provide RWE of their treatments in terms of effectiveness and safety","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"aged 18 or over - new diagnosis of ITP (since 2025, initiation of a maintenance treatment ofr ITP) or AIHA or initiaiton of a newly marketed drug in France for ITP or AIHA - no oppsition to participate\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Remote data quality check for all patients on a core set of 100 variables; on-site monitoring done in 2023-2024 in centers in 10% of the database']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"2832 on December 31, 2024"},"method_notes":"Observational Study","study_class":"Ongoing study","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Morbidity registry"]},{"subject":"follow-up","values":["Monitoring by contact with the participant (mail, e-mail, telephone etc.)"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Upon request, need the apprival by the scientific committee and the sponsor","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"03-01-2013","lastUpdatedAuto":null,"lastUpdatedManual":"10-11-2017","isContributorPI":"No","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)","Industry","Industry","Private non-profit"],"otherFundingAgentType":["","","",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"reseach assistants collect the data at each routine visit in each center, and enter the data in a unique electronic database","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Opening of other centers is planned. 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