{"doc_desc":{"title":"Etude longitudinale de patients atteints de cancers digestifs\/complications infectieuses li\u00e9es aux cath\u00e9ters veineux \u00e0 site implantables","idno":"FRESH-PEF5087-fr","producers":[{"name":"C\u00e9cile CHAMBRIER","affiliation":"HOSPICES CIVILS DE LYON (HCL)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5087-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5087"},{"agency":"FReSH","code":"FRESH-PEF5087"}]},"title":"Etude longitudinale de patients atteints de cancers digestifs\/complications infectieuses li\u00e9es aux cath\u00e9ters veineux \u00e0 site implantables","alternate_title":""},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"C\u00e9cile;CHAMBRIER","firstname":"C\u00e9cile","lastname":"CHAMBRIER","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"organisation id"},{"title":"SIREN","uri":"266900273","role":"organisation id"}],"email":"cecile.chambrier@chu-lyon.fr","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","PILabo":"Hospices Civils de Lyon \/ Unit\u00e9 CARMENInserm 1060\/ Inra 1235 (Equipe 1)","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"sponsor id"},{"title":"SIREN","uri":"266900273","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60"},{"title":"SIREN","uri":"266900273"}]},{"name":"SOCIETE FRANCOPHONE NUTRITION CLINIQUE ET METABOLISME (SFNEP)","extlink":[{"title":"SIREN","uri":"409128337"}]},{"name":""}]},"distribution_statement":{"contact":[{"name":"C\u00e9cile;CHAMBRIER","lastname":"CHAMBRIER","firstname":"C\u00e9cile","type":"contact","email":"cecile.chambrier@chu-lyon.fr","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01502ca60","role":"organisation id","title":"ROR"},{"uri":"266900273","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"cath\u00e9ter veineux central"},{"keyword":"\u00e9valuer"},{"keyword":"impact"},{"keyword":"incidence"},{"keyword":"infection"},{"keyword":"mortalit\u00e9"}],"topics":[{"topic":"Gastroent\u00e9rologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/a3898340-a42d-4f5e-a822-1de204a9a867"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005762"}]},{"topic":"H\u00e9patologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/27c456a1-051a-42f6-b52a-3beff0487da7"}]},{"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":"L\u2019objectif principal est d\u2019\u00e9valuer les facteurs de risques des infections li\u00e9es au cath\u00e9ter veineux central et la mortalit\u00e9 dans les 30 jours qui suivent la survenue de l\u2019infection chez des patients ayant un cancer digestif. L\u2019objectif secondaire est d\u2019\u00e9valuer l\u2019impact de la sarcop\u00e9nie sur l\u2019incidence d\u2019infection li\u00e9e au cath\u00e9ter veineux central et la mortalit\u00e9 dans les 30 jours qui suivent la survenue de l\u2019infection chez des patients ayant un cancer digestif.","abstract":"","coll_dates":[{"start":"2007-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Auvergne Rh\u00f4ne-Alpes']","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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients ayant un cancer digestif suivis depuis mars 2007,  \u00e2ge sup\u00e9rieur \u00e0 18 ans, chimioth\u00e9rapie intraveineuse, diagnostic d'un cancer digestif primitif, pose d'une voie veineuse centrale\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques']","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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"525"},"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":"11-12-2012","lastUpdatedAuto":null,"lastUpdatedManual":"11-08-2014","isContributorPI":false,"contributorName":"C\u00e9cile CHAMBRIER","contributorAffiliation":"HOSPICES CIVILS DE LYON (HCL)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/tinyurl.com\/Hal-Cancers-digestifs"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"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":"La date d\u2019inclusion correspond \u00e0 la date de pose de la voie veineuse centrale, chaque patient est suivi pendant 12 mois maximum. Les crit\u00e8res de fin d\u2019observation sont: l\u2019infection li\u00e9e au cath\u00e9ter veineux central , l\u2019arr\u00eat de la chimioth\u00e9rapie intraveineuse, l\u2019ablation du cath\u00e9ter, le transfert dans un autre h\u00f4pital ou le d\u00e9c\u00e8s","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Lyon"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"le taux d\u2019albumine, la prot\u00e9ine C r\u00e9active (CRP)","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}