{"doc_desc":{"title":"Cohorte de patients atteints de maladie r\u00e9nale chronique\/identification de nouveaux biomarqueurs et facteurs de risque g\u00e9n\u00e9tiques et environnementaux","idno":"FRESH-PEF60132-fr","producers":[{"name":"B\u00e9n\u00e9dicte STENGEL","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60132-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60132"},{"agency":"FReSH","code":"FRESH-PEF60132"}]},"title":"Cohorte de patients atteints de maladie r\u00e9nale chronique\/identification de nouveaux biomarqueurs et facteurs de risque g\u00e9n\u00e9tiques et environnementaux","alternate_title":"NEPHROTEST"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"B\u00e9n\u00e9dicte;STENGEL","PILabo":"INSERM \/ INSERM U1018 CENTRE DE RECHERCHE EN \u00c9PID\u00c9MIOLOGIE ET SANT\u00c9 DES POPULATIONS","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0001-9469-0804","role":"pi id"},{"title":"IdRef","uri":"087893452","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"201019083D","role":"labo id"}],"email":"benedicte.stengel@inserm.fr","isContact":"Oui"}],"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 DE LA BIOMEDECINE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03tajza86"},{"title":"SIREN","uri":"180092587"}]},{"name":"AMGEN","extlink":[{"title":"SIREN","uri":"377998679"}]},{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"MINISTERE DE L\u2019ENSEIGNEMENT SUPERIEUR, DE LA RECHERCHE ET DE L\u2019ESPACE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03sjk9a61"},{"title":"SIREN","uri":"110044013"}]}]},"distribution_statement":{"contact":[{"name":"B\u00e9n\u00e9dicte;STENGEL","email":"benedicte.stengel@inserm.fr","type":"contact","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":[{"keyword":"fonction r\u00e9nale"},{"keyword":"d\u00e9bit de filtration glom\u00e9rulaire"},{"keyword":"complications m\u00e9taboliques et vasculaires"},{"keyword":"traitement de suppl\u00e9ance r\u00e9nale"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"qualit\u00e9 de vie"},{"keyword":"mortalit\u00e9"}],"topics":[{"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"}]}],"purpose":"Objectif g\u00e9n\u00e9ral : Identifier de nouveaux biomarqueurs et facteurs de risque g\u00e9n\u00e9tiques et environnementaux de progression et de complications dans la maladie r\u00e9nale chronique. Objectifs secondaires : - D\u00e9crire l'histoire naturelle de la maladie r\u00e9nale chronique dans un contexte de prise en charge optimis\u00e9e selon les recommandations internationales - Evaluer l'obtention et la pertinence des objectifs recommand\u00e9s (K\/DOQI, KDIGO, HAS)","abstract":"","coll_dates":[{"start":"2001-01-01","end":"2012-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Nouvelle-Aquitaine','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\": \"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients \u00e2g\u00e9s de plus de 18 ans, atteints de maladie r\u00e9nale chronique confirm\u00e9e par la pr\u00e9sence de marqueurs de l\u00e9sions r\u00e9nales : anomalies biologiques ou morphologiques ou histologiques, et une mesure du d\u00e9bit de filtration glom\u00e9rulaire par une m\u00e9thode de r\u00e9f\u00e9rence (clairance r\u00e9nale du 51CR-EDTA), stades 1 \u00e0 5 de la classification Kdigo 2005, non dialys\u00e9s et non greff\u00e9s.\",\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','Donn\u00e9es paracliniques (hors biologiques) : Imagerie','Donn\u00e9es paracliniques (hors biologiques) : Autre']","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 Gestion des donn\u00e9es manquantes par retour au dossier source Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi Relance des sujets pour r\u00e9aliser les visites de suivi Autre(s) proc\u00e9dure(s) qualit\u00e9 : tableaux de bords de suivi, requ\u00eates de coh\u00e9rences pr\u00e9alables aux analyses 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\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 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":"[1000-10000[ individus","response_rate":"1835"},"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 possible des donn\u00e9es par des industriels via le comit\u00e9 de pilotage industriel","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":"12-08-2014","isContributorPI":"Non","contributorName":"B\u00e9n\u00e9dicte STENGEL","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/www.hal.inserm.fr\/NEPHROTEST"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Industrie","Industrie","Public (France)","Public (France)"],"otherFundingAgentType":["","","","",""]},"sponsor":{"sponsorType":["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":"Auto-questionnaire : saisie \u00e0 partir d\u2019un questionnaire papier (saisie manuelle) Entretiens : saisie \u00e0 partir d\u2019un questionnaire papier (saisie manuelle) Examens cliniques : \u00e9tape manuscrite (saisie manuelle) Examens biologiques : saisie directe (Autre) Autre type de saisie pour les examens biologiques : importation directe des donn\u00e9es des syst\u00e8mes de gestion de laboratoire (interfaces)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique (3 centres) fran\u00e7aise (Ile de France et Bordeaux)"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi tous les ansInformations recueillies lors de l'examen clinique : - examen clinique- histoire de la maladie r\u00e9nale - \u00e9v\u00e8nements cardiovasculaires- traitements","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : sang et urine","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}