{"doc_desc":{"title":"Etude observationnelle r\u00e9trospective faisant un \u00e9tat des lieux du test KRAS en 2011 chez des patients atteint d'un cancer colorectal m\u00e9tastatique ayant d\u00e9but\u00e9 r\u00e9cemment un traitement de premi\u00e8re ligne","idno":"FRESH-PEF73327-fr","producers":[{"name":"Juliette LONGIN","affiliation":"MERCK SANTE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73327-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73327"},{"agency":"FReSH","code":"FRESH-PEF73327"}]},"title":"Etude observationnelle r\u00e9trospective faisant un \u00e9tat des lieux du test KRAS en 2011 chez des patients atteint d'un cancer colorectal m\u00e9tastatique ayant d\u00e9but\u00e9 r\u00e9cemment un traitement de premi\u00e8re ligne","alternate_title":"Flash-KRAS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Pierre;LAURENT-PUIG","firstname":"Pierre","lastname":"LAURENT-PUIG","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"SIREN","uri":"267500452","role":"organisation id"}],"email":"","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","PILabo":"","isContact":false},{"name":"Astrid;LIEVRE","firstname":"Astrid","lastname":"LIEVRE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"SIREN","uri":"267500452","role":"organisation id"}],"email":"","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","PILabo":"","isContact":false},{"name":"Michel;GUIU","firstname":"Michel","lastname":"GUIU","type":"investigator","extlink":[{"title":"SIREN","uri":"315932525","role":"organisation id"}],"email":"","affiliationName":"CENTRE DE PATHOLOGIE DES DOCTEURS ISABELLE BIAL - CELINE LAMBOLAIS - ALEXANDRE NATAF - JEAN PHILIPPE MOMPART, CECILE BOR","PILabo":"","isContact":false},{"name":"Jean-Louis;MERLIN","firstname":"Jean-Louis","lastname":"MERLIN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016ncsr12","role":"organisation id"},{"title":"SIREN","uri":"200042166","role":"organisation id"}],"email":"","affiliationName":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","PILabo":"","isContact":false},{"name":"Jean-Christophe;SABOURIN","firstname":"Jean-Christophe","lastname":"SABOURIN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04cdk4t75","role":"organisation id"},{"title":"SIREN","uri":"267601680","role":"organisation id"}],"email":"","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE ROUEN","PILabo":"","isContact":false},{"name":"Pascal;ARTRU","firstname":"Pascal","lastname":"ARTRU","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"organisation id"},{"title":"SIREN","uri":"266900273","role":"organisation id"}],"email":"","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","PILabo":"","isContact":false},{"name":"Michel;DUCREUX","firstname":"Michel","lastname":"DUCREUX","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0321g0743","role":"organisation id"},{"title":"SIREN","uri":"775741101","role":"organisation id"}],"email":"","affiliationName":"INSTITUT GUSTAVE ROUSSY (IGR)","PILabo":"","isContact":false},{"name":"J\u00e9r\u00f4me;VIGUIER","firstname":"J\u00e9r\u00f4me","lastname":"VIGUIER","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02wwzvj46","role":"organisation id"},{"title":"SIREN","uri":"193708005","role":"organisation id"}],"email":"","affiliationName":"UNIVERSITE DE TOURS","PILabo":"","isContact":false}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"MERCK SANTE","extlink":[{"title":"SIREN","uri":"572028033","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MERCK SANTE","extlink":[{"title":"SIREN","uri":"572028033"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"Test-KRAS"},{"keyword":"Cancer colorectal"}],"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","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"}],"purpose":"Evaluer le taux de prescription du test KRAS chez des patients d\u00e9butant un traitement de premi\u00e8re ligne d'un cancer colorectal m\u00e9tastatique. Objectifs secondaires: - D\u00e9crire les raisons \u00e9ventuelles de non prescription de ce test - D\u00e9crire et analyser les caract\u00e9ristiques cliniques des patients et les traitements pr\u00e9vus et re\u00e7us en premi\u00e8re ligne m\u00e9tastatique - D\u00e9crire et analyser le d\u00e9lai d'obtention du r\u00e9sultat du test KRAS et le circuit (qui fait la demande, quand) et l'attitude th\u00e9rapeutique adopt\u00e9e pendant cette p\u00e9riode - Analyser l'impact de la disponibilit\u00e9 du test KRAS et de son r\u00e9sultat sur le choix th\u00e9rapeutique du m\u00e9decin - D\u00e9crire la technique utilis\u00e9e pour l'analyse, le type de mutation (si disponible) et la modalit\u00e9 de report des r\u00e9sultats aux cliniciens (compte rendu de r\u00e9sultat)","abstract":"","coll_dates":[{"start":"2011-01-01","end":"2011-12-31"}],"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\": \"Chaque centre participant devait s\u00e9lectionner l'exhaustivit\u00e9 des patients vus en consultation pendant la p\u00e9riode de r\u00e9alisation de l'\u00e9tude, r\u00e9pondant \u00e0 tous les crit\u00e8res  suivants: - Patients \u00e2g\u00e9s de 18 ans ou plus, - Patients atteints d'un cancer colorectal m\u00e9tastatique histologiquement prouv\u00e9, - Patients pour lesquels un traitement de premi\u00e8re ligne m\u00e9tastatique a \u00e9t\u00e9 initi\u00e9 entre le 01\\\/01\\\/2011 et le 27\\\/03\\\/2011, - Patients vus en consultation pendant la p\u00e9riode officielle des 2 semaines de s\u00e9lection de l'\u00e9tude.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Consommation 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 les professionnels d'exercice lib\u00e9ral 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":"[500-1000[ individus","response_rate":"n=538 patients (160 centres)"},"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":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"06-06-2016","lastUpdatedAuto":null,"lastUpdatedManual":"19-10-2017","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Dossier m\u00e9dical des patients vus en consultation pendant la p\u00e9riode de l'\u00e9tude de fa\u00e7on r\u00e9trospective et \u00e0 l'aide d'un questionnaire papier. 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