{"doc_desc":{"title":"Etude de cohorte prospective sur l'impact de la r\u00e9sistance \u00e0 l'insuline sur la r\u00e9ponse virologique soutenue au traitement Pegasys\u00ae et Copegus\u00ae chez les patients atteints d'h\u00e9patite C chronique","idno":"FRESH-PEF74113-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74113-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74113"},{"agency":"FReSH","code":"FRESH-PEF74113"},{"agency":"NCT","code":"NCT01200225"}]},"title":"Etude de cohorte prospective sur l'impact de la r\u00e9sistance \u00e0 l'insuline sur la r\u00e9ponse virologique soutenue au traitement Pegasys\u00ae et Copegus\u00ae chez les patients atteints d'h\u00e9patite C chronique","alternate_title":"ORPHEE"},"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","lastname":"Medical data center","firstname":"","type":"contact","email":"data_sharing.france@roche.com","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":"Traitement par Copegus\u00ae"}],"topics":[{"topic":"Infectiologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"H\u00e9patite virale","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/985510409","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 primaire : D\u00e9crire en conditions r\u00e9elles la r\u00e9sistance \u00e0 l'insuline et son impact sur la r\u00e9ponse virologique soutenue (RVS) chez des patients pr\u00e9sentant une h\u00e9patite C chronique et trait\u00e9s par Pegasys\u00ae et Copegus\u00ae. Objectifs secondaires : - D\u00e9crire les caract\u00e9ristiques des patients \u00e0 l'inclusion - D\u00e9crire les facteurs pr\u00e9dictifs influen\u00e7ant la r\u00e9ponse virologique sous traitement \u00e0 la 4\u1d49 semaine (r\u00e9ponse virologique rapide, RVR), \u00e0 la 12\u1d49 semaine (r\u00e9ponse virologique pr\u00e9coce, EVR), et 24 semaines apr\u00e8s la fin du traitement par Pegasys\u00ae (r\u00e9ponse virologique soutenue, SVR). - D\u00e9crire les param\u00e8tres constitutifs du syndrome m\u00e9tabolique au cours de la p\u00e9riode d'\u00e9tude - D\u00e9crire la prise en charge de l'h\u00e9patite C chronique et de l'insulinor\u00e9sistance - D\u00e9crire l'\u00e9volution de la qualit\u00e9 de vie des patients pendant la p\u00e9riode d'\u00e9tude - D\u00e9crire les \u00e9v\u00e9nements ind\u00e9sirables graves et non graves survenus au cours de la p\u00e9riode d'\u00e9tude.","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2013-01-01"}],"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 : - Patient adulte (\u00e2ge >=18 ans) - Souffrant d'une h\u00e9patite C chronique (ARN VHC d\u00e9tectable dans le sang) - Pour lequel le sp\u00e9cialiste a d\u00e9cid\u00e9 d'initier une bith\u00e9rapie avec Pegasys\u00ae et Copegus\u00ae. - Ayant re\u00e7u des informations orales et \u00e9crites sur l'\u00e9tude, sans aucune objection quant \u00e0 l'utilisation de ses donn\u00e9es personnelles.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques']","quality_statement":{"standards":[{"name":"","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 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\"}","{\"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":"1150"},"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":"","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":"17-01-2022","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Validation des crit\u00e8res de s\u00e9lection ; Donn\u00e9es d\u00e9mographiques des patients (\u00e2ge et sexe) ; Test de grossesse pour les femmes en \u00e2ge de procr\u00e9er ; Donn\u00e9es cliniques ; Co-morbidit\u00e9s et facteurs associ\u00e9s ; Ant\u00e9c\u00e9dents d'h\u00e9patite C chronique ; Donn\u00e9es biologiques les plus r\u00e9centes ; Donn\u00e9es histologiques les plus r\u00e9centes ; Traitement par Pegasys\u00ae et Copegus\u00ae ; Date d'arr\u00eat d\u00e9finitif du traitement par Pegasys\u00ae et motif(s) ; Mode de vie et recommandations th\u00e9rapeutiques, traitements concomitants ; Ev\u00e9nements ind\u00e9sirables ; Date et motif d'arr\u00eat pr\u00e9matur\u00e9 de l'\u00e9tude ; Questionnaire de qualit\u00e9 de vie (HQLQ).","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}