{"doc_desc":{"title":"Etude longitudinale sur des patients avec initiation de traitement par thalidomide ou l\u00e9nalidomide dans le cadre d\u2019un my\u00e9lome multiple: prophylaxie de la MTEV","idno":"FRESH-PEF96-fr","producers":[{"name":"Nadine MACKENZIE","affiliation":"LABORATOIRES LEO (LEO PHARMA)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF96-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"96"},{"agency":"FReSH","code":"FRESH-PEF96"}]},"title":"Etude longitudinale sur des patients avec initiation de traitement par thalidomide ou l\u00e9nalidomide dans le cadre d\u2019un my\u00e9lome multiple: prophylaxie de la MTEV","alternate_title":"MELISSE"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Anne;LAMBLIN","PILabo":"LEO Pharma \/ LEO Pharma France","affiliationName":"LABORATOIRES LEO (LEO PHARMA)","extlink":[{"title":"ORCID","uri":"0009-0001-8771-2478","role":"pi id"},{"title":"IdRef","uri":"076298566","role":"pi id"},{"title":"SIREN","uri":"572208122","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"anne.lamblin@leo-pharma.com","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"LABORATOIRES LEO (LEO PHARMA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02wvemr05","role":"sponsor id"},{"title":"SIREN","uri":"572208122","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02wvemr05"},{"title":"SIREN","uri":"572208122"}]}]},"distribution_statement":{"contact":[{"name":"Anne;LAMBLIN","email":"anne.lamblin@leo-pharma.com","type":"contact","affiliationName":"LABORATOIRES LEO (LEO PHARMA)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02wvemr05","role":"organisation id","title":"ROR"},{"uri":"572208122","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"prophylaxie"},{"keyword":"thalidomide"},{"keyword":"lenalidomide"}],"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":"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":"D\u00e9crire la prise en charge prophylactique de la maladie thromboembolique veineuse (MTEV) chez les patients atteints d\u2019un my\u00e9lome multiple et b\u00e9n\u00e9ficiant d\u2019un traitement par thalidomide ou l\u00e9nalidomide : - D\u00e9crire la proportion de patients qui b\u00e9n\u00e9ficient d\u2019un traitement prophylactique de la MTEV ; - D\u00e9finir la place des h\u00e9parines de bas poids mol\u00e9culaire (HBPM), des antivitamines K (AVK) et de l\u2019aspirine, ainsi que les modalit\u00e9s de leur utilisation, dans la prophylaxie de la MTEV. D\u00e9crire, sur une p\u00e9riode de 4 mois puis 8 mois, la survenue d\u2019\u00e9v\u00e8nements thromboemboliques et h\u00e9morragiques chez des patients avec my\u00e9lome multiple b\u00e9n\u00e9ficiant d\u2019un traitement par thalidomide ou l\u00e9nalidomide, en fonction de la strat\u00e9gie thromboprophylactique mise en place \u00e0 l\u2019inclusion","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2011-01-01"}],"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\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patient adulte avec initiation de traitement par thalidomide ou l\u00e9nalidomide dans le cadre d\u2019un my\u00e9lome multiple (1\u00e8re, 2\u00e8 ou 3\u00e8 ligne de chimioth\u00e9rapie). \",\n    \"clusion_E\": \"patient participant, ou ayant particip\u00e9 dans les trois mois pr\u00e9c\u00e9dents, \u00e0 une \u00e9tude biom\u00e9dicale sur les anticoagulants\"\n}","data_kind":"['Donn\u00e9es cliniques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","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\":\"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":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"10-09-2014","isContributorPI":"Non","contributorName":"Nadine MACKENZIE","contributorAffiliation":"LABORATOIRES LEO (LEO PHARMA)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"List of publications in Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=Lamblin+A[author]+AND+Melisse"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"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":"- Questionnaire centre : \u00e0 remplir par les centres acceptant de participer \u00e0 l'\u00e9tude. - Cahier de recueil de donn\u00e9es : \u00e0 remplir par les m\u00e9decins participants pour chaque patient screen\u00e9 et chaque patient inclus","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"60 centres hospitaliers disposant d\u2019un service d\u2019h\u00e9mato-oncologie, implant\u00e9s en France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","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"}