{"doc_desc":{"title":"Prescription and Utilisation of Low Molecular Weight Heparin (LMWH) in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism (VTE) in Patients With Cancer.","idno":"FRESH-PEF5615-en","producers":[{"name":"Nadine MACKENZIE","affiliation":"LABORATOIRES LEO (LEO PHARMA)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5615-en","IDno":{"metadata_no":[{"agency":"PEF","code":"5615"},{"agency":"FReSH","code":"FRESH-PEF5615"}]},"title":"Prescription and Utilisation of Low Molecular Weight Heparin (LMWH) in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism (VTE) in Patients With Cancer.","alternate_title":"TROPIQUE"},"study_authorization":{"agency":[]},"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":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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","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":"Venous thromboembolism"},{"keyword":"Cancer"},{"keyword":"LMWH"}],"topics":[{"topic":"Oncology","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":"Functions of the cardiovascular, haematological, immunological and respiratory systems","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/326705068","title":"CIM-11"}]},{"topic":"Malignant neoplasms of ill-defined or unspecified primary sites","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1594217552","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"To document the prescription and the use of LMWH in usual medical practice in France for the treatment of symptomatic VTE in patients with cancer. To assess the conformity of LMWH usage with national recommendations (www.sor-cancer.com et www.thrombose-cancer.com) for VTE treatment in patients with cancer. To evaluate thromboembolism recurrence, bleeding, thrombocytopenia and death as well as document the reasons for discontinuing treatment. To describe clinical factors associated with LMWH treatment duration and those associated with the occurrence of VTE in patients with cancer. To evaluate anticoagulant treatment perception in cancer patients in order to have a better knowledge of their LMWH treatment satisfaction.","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Men or women aged 18 years or more. Patients who have given oral consent to participate after receiving oral and written information concerning the study. Patients with a solid or liquid tumour confirmed by a histological or cytological examination and receiving anti-cancerous therapy or palliative care. Patients diagnosed with venous thromboembolism (VTE) defined as: - symptomatic proximal or distal deep vein thrombosis (DVP) - confirmed pulmonary embolism (PE) - visceral embolism - thrombosis from a long-term central venous catheter. Patients who have begun curative VTE treatment with LMWH for 7 days or more.\",\n    \"clusion_E\": \"Patients treated with LMWH for more than 7 days. Patients presenting contraindications to LMWH use confirmed by respective multidisciplinary meetings.\"\n}","data_kind":"['Clinical data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"155 (21\/03\/2013)"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"All requests to be sent to LEO Pharma","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"11-08-2014","isContributorPI":"No","contributorName":"Nadine MACKENZIE","contributorAffiliation":"LABORATOIRES LEO (LEO PHARMA)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25099690"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industry"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"A satisfaction questionnaire regarding LMWH treatment will be completed by the patient at baseline and at the end of their treatment.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}