{"doc_desc":{"title":"Etude longitudinale sur des patients atteints d\u2019un cancer colorectal m\u00e9tastatique ayant d\u00e9but\u00e9 un traitement par bevacizumab en premi\u00e8re ligne de traitement palliatif","idno":"FRESH-PEF2907-fr","producers":[{"name":"C\u00e9cile DROZ-PERROTEAU","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF2907-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"2907"},{"agency":"FReSH","code":"FRESH-PEF2907"}]},"title":"Etude longitudinale sur des patients atteints d\u2019un cancer colorectal m\u00e9tastatique ayant d\u00e9but\u00e9 un traitement par bevacizumab en premi\u00e8re ligne de traitement palliatif","alternate_title":"ETNA : Etude de Terrain sur les traitements iNnovants en canc\u00e9rologie : un anti-angiog\u00e9nique le b\u00e9vacizumab (Avastin\u00ae)"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Annie;FOURRIER-REGLAT","firstname":"Annie","lastname":"FOURRIER-REGLAT","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"organisation id"},{"title":"SIREN","uri":"130018351","role":"organisation id"}],"email":"annie.fourrier-reglat@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","PILabo":"Universit\u00e9 Bordeaux \/ Service de Pharmacologie, CIC1401- Universit\u00e9 de Bordeaux","isContact":true},{"name":"Nicholas;MOORE","firstname":"Nicholas","lastname":"MOORE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"organisation id"},{"title":"SIREN","uri":"130018351","role":"organisation id"}],"email":"nicholas.moore@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","PILabo":"Universit\u00e9 Bordeaux \/ Service de Pharmacologie, CIC1401 - Universit\u00e9 de Bordeaux","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"sponsor id"},{"title":"SIREN","uri":"130018351","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Annie;FOURRIER-REGLAT","lastname":"FOURRIER-REGLAT","firstname":"Annie","type":"contact","email":"annie.fourrier-reglat@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]},{"name":"Nicholas;MOORE","lastname":"MOORE","firstname":"Nicholas","type":"contact","email":"nicholas.moore@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Cancer colorectal m\u00e9tastatique"},{"keyword":"bevacizumab"},{"keyword":"Avastin\u00ae"},{"keyword":"premi\u00e8re ligne"},{"keyword":"conditions d\u2019utilisation"},{"keyword":"pharmaco-\u00e9pid\u00e9miologie"},{"keyword":"d\u00e9partement de pharmacologie"},{"keyword":"Bordeaux"},{"keyword":"tol\u00e9rance"},{"keyword":"survie"},{"keyword":"cohorte"}],"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":"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":"Les principaux objectifs de l'\u00e9tude \u00e9taient de d\u00e9crire la population des patients atteints d'un cancer colorectal m\u00e9tastatique et trait\u00e9s en vie r\u00e9elle par bevacizumab en 1\u00e8re ligne, d\u00e9crire les conditions d'utilisation de ce m\u00e9dicament, \u00e9valuer la tol\u00e9rance des traitements et l'efficacit\u00e9 en termes de r\u00e9ponse et survie globale et sans progression \u00e0 12 et 24 mois de suivi.","abstract":"","coll_dates":[{"start":"2007-01-01","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\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patient atteint d\u2019un cancer colorectal m\u00e9tastatique ayant d\u00e9but\u00e9 un traitement par bevacizumab en premi\u00e8re ligne de traitement palliatif quel que soit le traitement anticanc\u00e9reux associ\u00e9 entre le 1er janvier 2006 et le 31 d\u00e9cembre 2007 (que le traitement soit poursuivi ou non); D\u00e9lai entre une chimioth\u00e9rapie adjuvante du cancer primitif et l\u2019initiation du bevacizumab sup ou \u00e9gale \u00e0 6 mois ; Absence de chimioth\u00e9rapie en situation m\u00e9tastatique avant initiation du bevacizumab ; Patient n\u2019ayant jamais \u00e9t\u00e9 trait\u00e9 auparavant par bevacizumab, y compris au cours d\u2019un essai clinique ou en Autorisation Temporaire d\u2019Utilisation ; Patient dont le m\u00e9decin prescripteur ou le chef de service a accept\u00e9 de participer \u00e0 l\u2019\u00e9tude ; Patient ne participant pas \u00e0 un essai th\u00e9rapeutique (loi Huriet-S\u00e9rusclat), sauf s\u2019il b\u00e9n\u00e9ficie d\u2019un traitement standard (bras contr\u00f4le) dans une \u00e9tude Phase III en ouvert (bevacizumab connu) ; Patient ne s\u2019opposant pas au recueil des donn\u00e9es le concernant.\",\n    \"clusion_E\": \"\"\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":"['Base m\u00e9dico-administrative (de patients, Assurance Maladie\/Mutuelle) Registre de maladies, de d\u00e9c\u00e8s']"}},"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":"411"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"La propri\u00e9t\u00e9 des donn\u00e9es de l&#x27;\u00e9tude a fait l&#x27;objet d&#x27;une convention entre l&#x27;Universit\u00e9 de Bordeaux, le CHU de Bordeaux et le laboratoire."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"06-06-2011","lastUpdatedAuto":null,"lastUpdatedManual":"20-01-2021","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=%28Fourrier-Reglat+A[author]+OR+Moore+N[author]%29+AND+Etna"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie","Public (France)"],"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":"L\u2019ensemble des donn\u00e9es m\u00e9dicales n\u00e9cessaires pour l\u2019\u00e9tude est recueilli sur des cahiers d\u2019observation papiers \u00e0 partir des dossiers m\u00e9dicaux par des Attach\u00e9s de Recherche Clinique form\u00e9s pour cette \u00e9tude.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Pharmaciens et m\u00e9decins hospitaliers exer\u00e7ant en France m\u00e9tropolitaine"},"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"}