{"doc_desc":{"title":"Survie chez les patients adultes atteints de m\u00e9lanome avanc\u00e9 porteur d'une mutation BRAF V600 : \u00e9tude ambispective non interventionnelle d'une cohorte de patients trait\u00e9s par cobimetinib dans le cadre du programme fran\u00e7ais d'acc\u00e8s pr\u00e9coce (TAU).","idno":"FRESH-PEF74085-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74085-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74085"},{"agency":"FReSH","code":"FRESH-PEF74085"},{"agency":"NCT","code":"NCT03139513"}]},"title":"Survie chez les patients adultes atteints de m\u00e9lanome avanc\u00e9 porteur d'une mutation BRAF V600 : \u00e9tude ambispective non interventionnelle d'une cohorte de patients trait\u00e9s par cobimetinib dans le cadre du programme fran\u00e7ais d'acc\u00e8s pr\u00e9coce (TAU).","alternate_title":"MELANIS"},"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":"cobimetinib"}],"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":"Dermatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5375c411-6db9-40ed-a854-6554102a587b"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D003880"}]},{"topic":"Tumeurs malignes, d\u00e9clar\u00e9es ou suppos\u00e9es primitives, de localisations pr\u00e9cis\u00e9es, \u00e0 l'exception des tissus lympho\u00efde, h\u00e9matopo\u00ef\u00e9tique, du syst\u00e8me nerveux central ou de tissus apparent\u00e9s","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1643222460","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 : Estimer la survie globale des patients trait\u00e9s par le cobimetinib en association avec le vemurafenib. Objectifs secondaires : - \u00c9valuer la survie sans progression de la maladie (PFS) - Identifier les facteurs pronostiques de la survie globale - Identifier les facteurs pronostiques de la survie sans progression de la maladie (PFS) - D\u00e9crire la r\u00e9ponse au traitement (\u00e9valuation globale du m\u00e9decin) - D\u00e9crire le d\u00e9lai d'arr\u00eat du traitement. - Caract\u00e9riser les effets ind\u00e9sirables cibl\u00e9s du cobimetinib en association avec le vemurafenib dans des conditions r\u00e9elles d'utilisation. - D\u00e9crire le profil de s\u00e9curit\u00e9 \u00e0 long terme du cobimetinib en association avec le vemurafenib dans des conditions r\u00e9elles d'utilisation. Objectifs exploratoires : - D\u00e9crire la population de patients trait\u00e9s par le cobimetinib en association avec le vemurafenib. - D\u00e9crire l'utilisation du cobimetinib en association avec le vemurafenib.","abstract":"","coll_dates":[{"start":"2016-01-01","end":"2018-01-01"}],"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 \u00e2g\u00e9s d'au moins 18 ans - Patients inclus dans le programme d\u2019acc\u00e8s pr\u00e9coce (TAU) \u00e0 partir du 26 f\u00e9vrier 2015 - Patients atteints d'un m\u00e9lanome non r\u00e9s\u00e9cable ou m\u00e9tastatique pr\u00e9sentant une mutation BRAF V600 et trait\u00e9s par cobimetinib en association avec Zelboraf\u00ae (vemurafenib). - Pour les patients vivants : les patients qui ont \u00e9t\u00e9 inform\u00e9s verbalement et par \u00e9crit de cette \u00e9tude, qui ne s'opposent pas \u00e0 ce que leurs donn\u00e9es soient trait\u00e9es \u00e9lectroniquement ou soumises \u00e0 un contr\u00f4le de qualit\u00e9 et qui ont sign\u00e9 le formulaire de consentement. OU - Pour les patients d\u00e9c\u00e9d\u00e9s avant la p\u00e9riode d'inclusion : les patients qui n'ont pas exprim\u00e9 leur opposition lorsqu'ils \u00e9taient en vie. \",\n    \"clusion_E\": \"Patients vivants incapables de donner leur consentement \u00e9clair\u00e9 - Patients ayant d\u00e9j\u00e0 particip\u00e9 \u00e0 un essai clinique sur le cobimetinib\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","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":[{"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\":\"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":"< 500 individus","response_rate":"198"},"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":"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":"eCRF","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Type de donn\u00e9es collect\u00e9es : consentement \u00e9clair\u00e9, crit\u00e8res d'inclusion\/exclusion, date de la visite, donn\u00e9es d\u00e9mographiques, donn\u00e9es cliniques, ant\u00e9c\u00e9dents m\u00e9dicaux, ant\u00e9c\u00e9dents de la maladie et traitements ant\u00e9rieurs du m\u00e9lanome, traitement par cobimetinib, m\u00e9dicaments concomitants pour le m\u00e9lanome (y compris le vemurafenib), premi\u00e8re progression de la maladie, \u00e9valuation des l\u00e9sions (selon l'appr\u00e9ciation du m\u00e9decin), \u00e9tat vital, \u00e9v\u00e9nements ind\u00e9sirables cibl\u00e9s (avant l'inclusion), \u00e9v\u00e9nements ind\u00e9sirables (apr\u00e8s l'inclusion), fin pr\u00e9matur\u00e9e de l'\u00e9tude.","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"}