{"doc_desc":{"title":"Cohorte sur le syndrome nephrotique de l'enfant (2)","idno":"FRESH-PEF5128-fr","producers":[{"name":"Georges DESCHNESE","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5128-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5128"},{"agency":"FReSH","code":"FRESH-PEF5128"},{"agency":"NCT","code":"NCT01609426"}]},"title":"Cohorte sur le syndrome nephrotique de l'enfant (2)","alternate_title":"NEPHROVIR 2"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Georges;DESCHENES","PILabo":"INSERM - \/ INSERM UMR699","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0002-5158-2915","role":"pi id"},{"title":"IdRef","uri":"276588940","role":"pi id"},{"title":"SIREN","uri":"180036048","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":"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":"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":"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":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"Analyse"},{"keyword":"statut immuno-virologique"},{"keyword":"Epstein Barr Virus (EBV)"},{"keyword":"idiopathique"},{"keyword":"corticoth\u00e9rapie"},{"keyword":"lymphocytes B"},{"keyword":"rechutes"},{"keyword":"prot\u00e9inurie"},{"keyword":"glucocortico\u00efdes"},{"keyword":"immunosuppresseurs"},{"keyword":"impact"},{"keyword":"\u00e9volution"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"incidence"},{"keyword":"s\u00e9quelles"},{"keyword":"complications"}],"topics":[{"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":"N\u00e9phrologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3961e9d2-ab3b-451b-b246-20fc0ec3b0c4"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009398"}]},{"topic":"Syndrome n\u00e9phrotique","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1184209951","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"Analyser le statut immuno-virologique des patients vis-\u00e0-vis de l\u2019Epstein Barr Virus (EBV), lors de la premi\u00e8re manifestation de syndrome n\u00e9phrotique idiopathique et de son impact sur l\u2019\u00e9volution sous corticoth\u00e9rapie. L'\u00e9tude compl\u00e9mentaire propos\u00e9e a pour objectif la caract\u00e9risation et l\u2019analyse du ph\u00e9notype des lymphocytes B des patients en relation avec le cycle de l\u2019EBV.","abstract":"","coll_dates":[{"start":"2007-01-01","end":"2020-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France']","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\": \"Enfants \u00e2g\u00e9s de 6 mois \u00e0 15 ans, r\u00e9sidant en Ile de France, avec une premi\u00e8re pouss\u00e9e de syndrome n\u00e9phrotique idiopathique, d\u00e9finie par une prot\u00e9inurie sup\u00e9rieure \u00e0 50 mg\\\/kg \\\/jour ou prot\u00e9inurie\\\/cr\u00e9atininurie sup\u00e9rieur \u00e0 0,25 g\\\/mmol et une hypoalbumin\u00e9mie inf\u00e9rieure \u00e0 30 g\\\/L, pour le groupe 2 : la n\u00e9gativit\u00e9 des s\u00e9rologies des virus de l\u2019h\u00e9patite B et de l\u2019h\u00e9patite C, l\u2019absence d\u2019abaissement de la fraction C3 ; ou pour le groupe 3 : pr\u00e9l\u00e8vements pour les s\u00e9rologies des virus de l\u2019h\u00e9patite B, de l\u2019h\u00e9patite C et de la fraction C3 du compl\u00e9ment. Les enfants ne r\u00e9sidant pas en Ile de France \u00e0 la premi\u00e8re pouss\u00e9e ne seront pas inclus.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques']","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 par retour vers le patient ou retour vers un tiers Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi Relance des sujets pour r\u00e9aliser les visites de suivi 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\r\nConsommation de soins\/services de sant\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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"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":"350"},"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 non possible des donn\u00e9es par des industriels","conditions":"Condition d&#x27;acc\u00e8s contractuelle","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":"14-12-2012","lastUpdatedAuto":null,"lastUpdatedManual":"06-08-2014","isContributorPI":"Non","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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 pr\u00e9l\u00e8vements de sang (2.5 mL sur EDTA et 2 tubes de 2.4 mL sur ACD) pr\u00e9lev\u00e9s pour l\u2019\u00e9tude au cours d\u2019un bilan biologique de routine seront adress\u00e9s au Centre d\u2019Investigation Clinique (CIC) de l\u2019h\u00f4pital Robert-Debr\u00e9 : Le tube sur EDTA sera imm\u00e9diatement achemin\u00e9 au laboratoire de pharmacologie pour recueil du plasma et extraction de l\u2019ADN avant aliquotage et cong\u00e9lation, puis \u00e9tude g\u00e9n\u00e9tique. Autoquestionnaire : Saisie \u00e0 partir d\u2019un questionnaire papier (Saisie manuelle)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Ile de France"},"dataTypes":{"clinicalDataDetails":"Autoquestionnaire au cours du suivi tous les deux ans Informations recueillies par l'autoquestionnaire : survenue de r\u00e9cidive, coordonn\u00e9es du m\u00e9decin consult\u00e9 ordonnance, mise a jour des coordonn\u00e9es personnelles Autre fiche d'information au cours du suivi tous les deux ans remplie par le m\u00e9decin traitant Informations recueillies par l'autre fiche d'information : donn\u00e9es cliniques et biologiques : rechutes, complications, donn\u00e9es th\u00e9rapeutiques : traitements et doses","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"}