{"doc_desc":{"title":"Etude longitudinale sur des patients atteints de la maladie thromboembolique veineuse (MTEV) suite \u00e0 une maladie canc\u00e9reuse: prescription et utilisation des H\u00e9parines de Bas Poids Mol\u00e9culaire (HBPM)","idno":"FRESH-PEF5615-fr","producers":[{"name":"Nadine MACKENZIE","affiliation":"LABORATOIRES LEO (LEO PHARMA)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5615-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5615"},{"agency":"FReSH","code":"FRESH-PEF5615"}]},"title":"Etude longitudinale sur des patients atteints de la maladie thromboembolique veineuse (MTEV) suite \u00e0 une maladie canc\u00e9reuse: prescription et utilisation des H\u00e9parines de Bas Poids Mol\u00e9culaire (HBPM)","alternate_title":"TROPIQUE"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"authoring_entity":[{"name":"Anne;LAMBLIN","firstname":"Anne","lastname":"LAMBLIN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02wvemr05","role":"organisation id"},{"title":"SIREN","uri":"572208122","role":"organisation id"}],"email":"anne.lamblin@leo-pharma.com","affiliationName":"LABORATOIRES LEO (LEO PHARMA)","PILabo":"LEO Pharma \/ LEO Pharma France","isContact":true}],"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":"LABORATOIRES LEO (LEO PHARMA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02wvemr05"},{"title":"SIREN","uri":"572208122"}]}]},"distribution_statement":{"contact":[{"name":"Anne;LAMBLIN","lastname":"LAMBLIN","firstname":"Anne","type":"contact","email":"anne.lamblin@leo-pharma.com","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":"Venous thromboembolism"},{"keyword":"LMWH"},{"keyword":"Cancer"}],"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":"Fonctions des syst\u00e8mes cardiovasculaire, h\u00e9matopo\u00ef\u00e9tique, immunitaire et respiratoire","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/326705068","title":"CIM-11"}]},{"topic":"Tumeurs malignes de localisations primitives mal d\u00e9finies ou non pr\u00e9cis\u00e9es","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1594217552","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":"D\u00e9crire les modalit\u00e9s de prescription et d\u2019utilisation des HBPM en pratique courante en France, dans le traitement de la MTEV symptomatique chez les patients atteints d\u2019une maladie canc\u00e9reuse. Evaluer la conformit\u00e9 de l\u2019utilisation des HBPM avec les recommandations nationales (www.sor-cancer.com et www.thrombose-cancer.com) sur le traitement de la MTEV chez le patient atteint d\u2019une maladie canc\u00e9reuse. Evaluer les r\u00e9cidives thromboemboliques, les h\u00e9morragies, les thrombocytop\u00e9nies ainsi que les d\u00e9c\u00e8s et documenter les raisons d\u2019arr\u00eat du traitement. D\u00e9crire les facteurs cliniques associ\u00e9s \u00e0 la dur\u00e9e de la prescription des HBPM et ceux associ\u00e9s \u00e0 la survenue d\u2019une MTEV chez les patients atteints d\u2019une maladie canc\u00e9reuse. Evaluer la perception du traitement anticoagulant par le patient atteint d\u2019une maladie canc\u00e9reuse afin de mieux connaitre sa satisfaction vis-\u00e0-vis de son traitement par HBPM.","abstract":"","coll_dates":[{"start":"2012-01-01","end":"2014-01-01"}],"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\": \"Homme ou femme \u00e2g\u00e9(e) de 18 ans ou plus. Patient ayant donn\u00e9 son consentement oral de participation apr\u00e8s avoir re\u00e7u les informations orales et \u00e9crites concernant l\u2019\u00e9tude.  Patient atteint d\u2019une tumeur solide ou liquide confirm\u00e9e par un examen histologique ou cytologique, et recevant une th\u00e9rapie anticanc\u00e9reuse ou des soins palliatifs. Patient ayant un diagnostic r\u00e9cent de la maladie thromboembolique veineuse (MTEV) d\u00e9finie par : -une thrombose veineuse profonde (TVP) symptomatique proximale ou distale  -une embolie pulmonaire (EP) confirm\u00e9e -une embolie visc\u00e9rale -une thrombose sur cath\u00e9ter veineux central de longue dur\u00e9e. Patient ayant initi\u00e9 le traitement curatif de la MTEV par HBPM depuis 7 jours au plus.  \",\n    \"clusion_E\": \"Patient trait\u00e9 par HBPM depuis plus de 7 jours Patient pr\u00e9sentant des contre-indications \u00e0 l\u2019utilisation des HBPM, conform\u00e9ment aux RCP respectifs\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","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 individus","response_rate":"155 (21\/03\/2013)"},"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":"Toute demande doit \u00eatre faite aupr\u00e8s de LEO Pharma","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"11-08-2014","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25099690"}],"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":"Un questionnaire de satisfaction vis-\u00e0-vis du traitement par HBPM sera rempli par le patient \u00e0 l\u2019inclusion et \u00e0 la fin de son traitement.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"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"}