{"doc_desc":{"title":"Cohorte de suivi des enfants atteints de cytopenie auto-immune s\u00e9v\u00e8re","idno":"FRESH-PEF60196-fr","producers":[{"name":"Yves PEREL","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60196-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60196"},{"agency":"FReSH","code":"FRESH-PEF60196"}]},"title":"Cohorte de suivi des enfants atteints de cytopenie auto-immune s\u00e9v\u00e8re","alternate_title":"BIOCEREVANCE 1"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Nathalie;ALADJIDI","PILabo":"CHU \/ UNIT\u00c9 D'HEMATO-ONCOLOGIE P\u00c9DIATRIQUE - CEREVANCE","affiliationName":"chu","extlink":[{"title":"ORCID","uri":"0000-0003-0231-4460","role":"pi id"},{"title":"IdRef","uri":"091935172","role":"pi id"},{"title":"SIREN","uri":"263305823","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"nathalie.aladjidi@chu-bordeaux.fr","isContact":"Oui"},{"type":"investigator","name":"Yves;PEREL","PILabo":"CHU \/ UNIT\u00c9 D'HEMATO-ONCOLOGIE P\u00c9DIATRIQUE","affiliationName":"chu","extlink":[{"title":"ORCID","uri":"0000-0001-5537-5668","role":"pi id"},{"title":"IdRef","uri":"067290124","role":"pi id"},{"title":"","uri":"","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01hq89f96","role":"sponsor id"},{"title":"SIREN","uri":"263305823","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Nathalie;ALADJIDI","email":"nathalie.aladjidi@chu-bordeaux.fr","type":"contact","affiliationName":"chu","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01hq89f96","role":"organisation id","title":"ROR"},{"uri":"263305823","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"\u00e9volution clinique"},{"keyword":"an\u00e9mies h\u00e9molytiques auto-immunes"},{"keyword":"syndrome d'Evans"},{"keyword":"purpura thrombop\u00e9nique immunologique chroniques"},{"keyword":"r\u00e9seau de recherche"},{"keyword":"bioth\u00e8que"},{"keyword":"facteurs pronostiques"},{"keyword":"enfant"},{"keyword":"m\u00e9canismes physiopathologiques"}],"topics":[{"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":"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":"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":"Purpura thrombocytop\u00e9nique immun","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/364346400","title":"CIM-11"}]},{"topic":"An\u00e9mie h\u00e9molytique auto-immune \u00e0 anticorps chauds","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/880772122","title":"CIM-11"}]},{"topic":"Syndrome d'Evans","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1048228553","title":"CIM-11"}]}],"purpose":"Objectif g\u00e9n\u00e9ral : - \u00c9tudier de fa\u00e7on prospective l\u2019\u00e9volution clinique et paraclinique et les facteurs pronostiques des an\u00e9mies h\u00e9molytiques auto-immunes, des syndromes d'Evans et des purpura thrombopenique immunologique chroniques de l\u2019enfant en France - \u00c9tablir ainsi le support d\u2019un r\u00e9seau de recherche fondamentale et th\u00e9rapeutique pour ces trois pathologies Objectifs secondaires - Constituer une bioth\u00e8que afin d\u2019\u00e9tudier les m\u00e9canismes physiopathologiques de ces maladies - \u00c9tablir le support d\u2019un r\u00e9seau national de recherche \u00e9pid\u00e9miologique, clinique, biologique et th\u00e9rapeutique sur ces maladies","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2011-01-01"}],"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\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\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\": \"\u00catre \u00e2g\u00e9 de moins de 18 ans et \u00eatre affili\u00e9 \u00e0 un r\u00e9gime de s\u00e9curit\u00e9 sociale R\u00e9sider en France m\u00e9tropolitaine Patient atteint d\u2019AHAI, de PTI chronique et\\\/ou de SE, quelque soit le terrain sous-jacent Consentement libre, \u00e9clair\u00e9, \u00e9crit et sign\u00e9 des titulaires de l\u2019autorit\u00e9 parentale, et de l\u2019enfant ou l\u2019adolescent s\u2019il est en \u00e2ge  \",\n    \"clusion_E\": \"an\u00e9mie h\u00e9molytique constitutionnelle et maladie plaquettaire constitutionnelle\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques. Retour au dossier source pour la gestion des donn\u00e9es manquantes. Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi. Relance des sujets pour r\u00e9aliser les visites de suivi. R\u00e9alisation d\\'audit internes de qualit\u00e9. 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":"['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":"262"},"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 \u00e0 d\u00e9terminer Utilisation possible 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":"17-02-2015","isContributorPI":"Non","contributorName":"Nathalie ALADJIDI","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.cerevance.org\/articles-scientifiques"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":"Oui"},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Examens cliniques : saisie manuelle avec double saisie Examens biologiques : saisie manuelle avec double saisie","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique (30 centres) fran\u00e7aise"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi : poids, taille, mode de vie, signes h\u00e9morragiques, signes d'an\u00e9mie, infections, syndrome tumoral, pathologie d'organe...","biologicalDataDetails":"NFS, r\u00e9ticulocytes, groupe sanguin, rh\u00e9sus, marqueurs d'h\u00e9molyse (haptoglobine, LDH, bilirubine totale et non conjugu\u00e9e), fonction r\u00e9nale, bilan h\u00e9patique, Test de Coombs, MAIPA, dosage pond\u00e9ral des immunoglobulines, ph\u00e9notypage lymphocytaire, auto-anticorps (FAN, antiDNA, anti-phospholipides, thyro\u00efde...), autres examens selon le contexte clinique","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}