{"doc_desc":{"title":"Etude de suivi de coHORte de 5 ans des patIents ayant initi\u00e9 le pembroliZumab en traitement de leur m\u00e9lanOme avanc\u00e9 au cours de son autorisatioN temporaire d\u2019utilisation (ATU)","idno":"FRESH-PEF73345-fr","producers":[{"name":"Laurie LEVY-BACHELOT","affiliation":"MSD FRANCE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73345-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73345"},{"agency":"FReSH","code":"FRESH-PEF73345"}]},"title":"Etude de suivi de coHORte de 5 ans des patIents ayant initi\u00e9 le pembroliZumab en traitement de leur m\u00e9lanOme avanc\u00e9 au cours de son autorisatioN temporaire d\u2019utilisation (ATU)","alternate_title":"HORIZON"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Rodolphe;MONTIN","firstname":"Rodolphe","lastname":"MONTIN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12","role":"organisation id"},{"title":"SIREN","uri":"417890589","role":"organisation id"}],"email":"","affiliationName":"MSD FRANCE","PILabo":"","isContact":false}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"MSD FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12","role":"sponsor id"},{"title":"SIREN","uri":"417890589","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MSD FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12"},{"title":"SIREN","uri":"417890589"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[],"topics":[{"topic":"Oncologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D008495"}]},{"topic":"Tumeurs","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]}],"purpose":"L\u2019objectif primaire est de d\u00e9crire la survie globale \u00e0 5 ans apr\u00e8s l\u2019initiation du pembrolizumab chez des patients atteints de m\u00e9lanome avanc\u00e9 (non r\u00e9s\u00e9cable ou m\u00e9tastatique).","abstract":"","coll_dates":[{"start":"","end":""}],"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\": \"Inclusion :  Dans chaque centre, tous les patients respectant les crit\u00e8res suivants seront inclus : 1.Patient ayant initi\u00e9 un traitement par pembrolizumab dans le cadre de l\u2019ATU ; 2.Patient n\u2019ayant pas exprim\u00e9 un refus de participer \u00e0 l\u2019\u00e9tude de suivi \u00e0 long-terme.  Les patients d\u00e9c\u00e9d\u00e9s ou perdus de vue au moment de l\u2019initiation de l\u2019\u00e9tude seront \u00e9galement inclus dans l\u2019analyse, s\u2019ils n\u2019avaient pas exprim\u00e9 de refus quant \u00e0 la collecte ou le traitement de donn\u00e9es les concernant.  Ainsi, \u00e0 l\u2019initiation de l\u2019\u00e9tude, les patients inclus pourront se trouver dans l\u2019une des situations suivantes : 1.Patient d\u00e9c\u00e9d\u00e9 avant l\u2019initiation de l\u2019\u00e9tude ; 2.Patient perdu de vue avant l\u2019initiation de l\u2019\u00e9tude ; 3.Patient ayant d\u00e9finitivement arr\u00eat\u00e9 le pembrolizumab avant l\u2019initiation de l\u2019\u00e9tude ; 4.Patient toujours trait\u00e9 par pembrolizumab au moment de l\u2019initiation de l\u2019\u00e9tude.   \",\n    \"clusion_E\": \"1Patient refusant de participer \u00e0 l\u2019\u00e9tude ou ayant exprim\u00e9 son refus quant \u00e0 la collecte ou le traitement des donn\u00e9es le concernant ; 2Patient \u00e2g\u00e9 de moins de 18 ans \"\n}","data_kind":"['Donn\u00e9es cliniques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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":""}},"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":"Pas d\u2019acc\u00e8s","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"600"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"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":"----","lastUpdatedAuto":null,"lastUpdatedManual":"29-10-2020","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"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":"Pas de d\u00e9tails"},"dataTypes":{"clinicalDataDetails":"","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"}