{"doc_desc":{"title":"Identification des facteurs permettant d'optimiser la prise en charge th\u00e9rapeutique de l'an\u00e9mie chez les patients atteints de maladie r\u00e9nale chronique trait\u00e9s par activateur continu du r\u00e9cepteur de l\u2019\u00e9rythropo\u00ef\u00e9tine (C.E.R.A.)","idno":"FRESH-PEF74090-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74090-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74090"},{"agency":"FReSH","code":"FRESH-PEF74090"}]},"title":"Identification des facteurs permettant d'optimiser la prise en charge th\u00e9rapeutique de l'an\u00e9mie chez les patients atteints de maladie r\u00e9nale chronique trait\u00e9s par activateur continu du r\u00e9cepteur de l\u2019\u00e9rythropo\u00ef\u00e9tine (C.E.R.A.)","alternate_title":"OPTICERA"},"study_authorization":{"agency":[{"name":"Autre"}]},"authoring_entity":[],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":";Medical data center","email":"data_sharing.france@roche.com","type":"contact","affiliationName":"F. HOFFMANN-LA ROCHE AG","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01mqmer16","role":"organisation id","title":"ROR"},{"uri":"775752140","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"M\u00e9thoxy-poly\u00e9thyl\u00e8ne glycol-\u00e9po\u00e9tine b\u00eata"}],"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"}]},{"topic":"An\u00e9mie due \u00e0 une maladie chronique","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1981248479","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"}],"purpose":"Objectif principal : Identifier les facteurs potentiels d'optimisation de la prise en charge th\u00e9rapeutique de l'an\u00e9mie r\u00e9nale avec l'activateur continu du r\u00e9cepteur de l\u2019\u00e9rythropo\u00ef\u00e9tine (C.E.R.A.). Objectifs secondaires : - Analyse de la r\u00e9ponse th\u00e9rapeutique au C.E.R.A., selon 4 d\u00e9finitions (atteinte ou maintien de la concentration d'Hb dans l'intervalle th\u00e9rapeutique cible de [10-12] g\/dL, limitation de la variabilit\u00e9 de l'Hb \u00e0 +\/- 1 g\/dL par rapport \u00e0 la valeur de base, les deux crit\u00e8res ci-dessus, ou au moins l'un des crit\u00e8res ci-dessus, apr\u00e8s une p\u00e9riode de traitement de 3 mois). - Description des caract\u00e9ristiques du patient et de la maladie lors de la premi\u00e8re injection de C.E.R.A. - Description de l'\u00e9volution de la prise en charge de la maladie r\u00e9nale chronique (examen physique, param\u00e8tres de laboratoire, y compris les valeurs d'h\u00e9moglobine et la fonction r\u00e9nale, traitements concomitants ant\u00e9rieurs et en cours pour l'an\u00e9mie, ainsi que les maladies et traitements concomitants) sous le traitement C.E.R.A. - Recherche d'associations\/corr\u00e9lations entre les variables et d\u00e9tection de profils particuliers.","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2015-01-01"}],"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\": \"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\u00e8res d'inclusion : - Patients atteints de maladie r\u00e9nale chronique ayant commenc\u00e9 un traitement par C.E.R.A. \u00e0 l'inclusion. - Avec au moins une valeur d'Hb dans les 3 mois pr\u00e9c\u00e9dant la premi\u00e8re injection de C.E.R.A. - Ne pas avoir particip\u00e9 \u00e0 une \u00e9tude interventionnelle\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques']","quality_statement":{"standards":[{"name":"['similaire \u00e0 CDISC']","committee":"","governance":""}],"other_quality_statement":"['Bonnes pratiques cliniques\/Bonnes Pratiques de Pharmacovigilance (GCP\/GVP)']"}},"study_development":{"development_activity":[]},"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']"}},"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":"[1000-10000[ individus","response_rate":"2984"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"","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":"02-11-2021","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":"Non","contributorName":"Camille BACHOT","contributorAffiliation":"F. HOFFMANN-LA ROCHE AG","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"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":"Pool de 5 bases de donn\u00e9es non interventionnelles","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Mise en commun de 5 \u00e9tudes non-interventionnelles avec Mircera\u00ae (OCEANE \/ HORTENSIA \/ COMETE \/ PERCEPOLIS \/ MIRIADE). Type de donn\u00e9es recueillies : donn\u00e9es d\u00e9mographiques, comorbidit\u00e9s, ant\u00e9c\u00e9dents de maladie r\u00e9nale chronique, traitements ant\u00e9rieurs de l'an\u00e9mie, donn\u00e9es de laboratoire, premi\u00e8re injection de C.E.R.A., autres traitements, signes vitaux, traitement de l'an\u00e9mie, injections de C.E.R.A., autres traitements, retrait pr\u00e9matur\u00e9.","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}