{"doc_desc":{"title":"Etude longitudinale sur des patients trait\u00e9s en premi\u00e8re ligne m\u00e9tastatique pour un cancer colorectal par le c\u00e9tuximab\u00ae : \u00e9valuation des th\u00e9rapies cibl\u00e9es","idno":"FRESH-PEF2887-fr","producers":[{"name":"C\u00e9cile DROZ-PERROTEAU","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF2887-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"2887"},{"agency":"FReSH","code":"FRESH-PEF2887"}]},"title":"Etude longitudinale sur des patients trait\u00e9s en premi\u00e8re ligne m\u00e9tastatique pour un cancer colorectal par le c\u00e9tuximab\u00ae : \u00e9valuation des th\u00e9rapies cibl\u00e9es","alternate_title":"EREBUS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"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},{"name":"Magali;ROUYER","firstname":"Magali","lastname":"ROUYER","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"organisation id"},{"title":"SIREN","uri":"130018351","role":"organisation id"}],"email":"","affiliationName":"UNIVERSITE DE BORDEAUX","PILabo":"Universit\u00e9 de Bordeaux \/ Bordeaux PharmacoEpi","isContact":false}],"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":"MERCK SANTE","extlink":[{"title":"SIREN","uri":"572028033"}]}]},"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":"c\u00e9tuximab\uf8e8"},{"keyword":"erbitux"},{"keyword":"condition d\u2019utilisation"},{"keyword":"Cancer colorectal m\u00e9tastatique"},{"keyword":"premi\u00e8re ligne"},{"keyword":"tol\u00e9rance"},{"keyword":"survie"},{"keyword":"pharmaco-\u00e9pid\u00e9miologie"},{"keyword":"cohorte"},{"keyword":"d\u00e9partement de pharmacologie"},{"keyword":"Bordeaux"}],"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":"L\u2019objectif principal est d\u2019\u00e9valuer le taux de r\u00e9section secondaire des m\u00e9tastases \u00e0 12 mois en situation r\u00e9elle de soins chez des patients atteints de cancer colorectal trait\u00e9s en premi\u00e8re ligne m\u00e9tastatique par c\u00e9tuximab.","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2012-01-01"}],"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 d\u00e9butant un traitement par c\u00e9tuximab en 1\u00e8re ligne entre le 1er janvier 2009 et le 31 d\u00e9cembre 2010, que le traitement soit poursuivi ou non ; Patient n\u2019ayant jamais \u00e9t\u00e9 trait\u00e9 auparavant par c\u00e9tuximab, y compris au cours d\u2019un essai clinique ou en Autorisation Temporaire d\u2019Utilisation ; Patient na\u00eff de chimioth\u00e9rapie en situation m\u00e9tastatique palliative ; Pas de chimioth\u00e9rapie n\u00e9oadjuvante\\\/adjuvante du cancer primitif ou d\u00e9lai entre cette derni\u00e8re et l\u2019initiation de la 1\u00e8re ligne de traitement avec c\u00e9tuximab sup ou \u00e9gal \u00e0 6 mois (avec une tol\u00e9rance de 15 jours) ; Pas de chimioth\u00e9rapie n\u00e9oadjuvante\\\/adjuvante du cancer m\u00e9tastatique ou d\u00e9lai entre cette derni\u00e8re et l\u2019initiation de la 1\u00e8re ligne de traitement avec c\u00e9tuximab sup ou \u00e9gal \u00e0 12 mois (avec une tol\u00e9rance de 1 mois) ; Patient avec m\u00e9tastases non r\u00e9s\u00e9cables d\u2019embl\u00e9e avant initiation du c\u00e9tuximab ; Patient avec statut K-RAS non mut\u00e9 ; Patient ne participant pas \u00e0 un essai clinique ou le cas \u00e9ch\u00e9ant, il aura \u00e9t\u00e9 jug\u00e9 par le centre coordinateur que les conditions de prise en charge ne sont pas modifi\u00e9es par l\u2019essai ; Patient sans rechute loco-r\u00e9gionale exclusive ; Patient ne s\u2019opposant pas au recueil des donn\u00e9es le concernant.\",\n \"clusion_E\": \"Patient ne s\u2019opposant pas au recueil des donn\u00e9es le concernant\"\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\":\"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":"En cours de recrutement, 2755 patients identifi\u00e9s par les pharmaciens hospitaliers, dont 1047 patients pour lesquels le m\u00e9decin a accept\u00e9 de participer \u00e0 l'\u00e9tude, dont 205 \u00e9ligibles pour le suivi en 2009 - Currently being recruited, 2755 patients identified by hospital pharmacists, including 1047 patients for whom their physician agreed to participate in the study, 205 eligible for follow-up in 2009."},"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'\u00e9tude a fait l'objet d'une convention entre l'Universit\u00e9 de Bordeaux et le laboratoire."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"31-05-2011","lastUpdatedAuto":null,"lastUpdatedManual":"20-01-2021","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"https:\/\/pubmed.ncbi.nlm.nih.gov\/29523416\/"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"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":"Les ARCs du centre coordinateur organisent durant la p\u00e9riode d\u2019inclusion et de suivi de l\u2019\u00e9tude, des visites dans les services hospitaliers pour recueillir sur e-CRF les informations n\u00e9cessaires pr\u00e9sentes dans les dossiers m\u00e9dicaux des patients s\u00e9lectionn\u00e9s.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"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"}