{"doc_desc":{"title":"\u00c9tude r\u00e9trospective observationnelle explorant les pratiques de tests de mutation RAS chez les patients atteints de cancer colorectal m\u00e9tastatique en 2014","idno":"FRESH-PEF73329-fr","producers":[{"name":"Juliette LONGIN","affiliation":"MERCK SANTE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73329-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73329"},{"agency":"FReSH","code":"FRESH-PEF73329"}]},"title":"\u00c9tude r\u00e9trospective observationnelle explorant les pratiques de tests de mutation RAS chez les patients atteints de cancer colorectal m\u00e9tastatique en 2014","alternate_title":"Flash-RAS"},"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":"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}],"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":"Tests de mutation RAS"},{"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":"\u00c9valuer les taux de demande et de r\u00e9alisation du test de d\u00e9pistage de la mutation RAS (KRAS et NRAS exons 2, 3 et 4) chez les patients ayant re\u00e7u un diagnostic r\u00e9cent de cancer colorectal m\u00e9tastatique. Objectifs secondaires : - D\u00e9crire l'\u00e9volution du taux de demande de test de d\u00e9pistage de la mutation KRAS (exon 2) entre 2011 et 2014 ; - D\u00e9crire les raisons de la demande\/absence de demande et de la r\u00e9alisation\/absence de r\u00e9alisation de ces tests en fonction des profils des m\u00e9decins et des patients. - D\u00e9crire et analyser l'impact des r\u00e9sultats KRAS (exons 2,3 et 4) et NRAS (exons 2.3 et 4), de la disponibilit\u00e9 du service d'anatomopathologie pour la r\u00e9alisation des tests et du r\u00e9sultat BRAF, sur la prise de d\u00e9cision th\u00e9rapeutique ou la modification du traitement en cours ; - D\u00e9crire et analyser les caract\u00e9ristiques cliniques des patients et les traitements pr\u00e9vus et re\u00e7us en premi\u00e8re intention pour le traitement de la maladie m\u00e9tastatique ; - D\u00e9crire la m\u00e9thode de test de laboratoire, le type de mutation recherch\u00e9e (si disponible) et la m\u00e9thode et la voie par laquelle le r\u00e9sultat a \u00e9t\u00e9 communiqu\u00e9 aux m\u00e9decins (rapport de r\u00e9sultat) ; - D\u00e9crire et analyser le d\u00e9lai de r\u00e9ception des r\u00e9sultats KRAS et NRAS, le processus (qui a demand\u00e9 le test et quand) et l'approche th\u00e9rapeutique choisie pendant cette p\u00e9riode.","abstract":"","coll_dates":[{"start":"2014-01-01","end":"2014-12-31"}],"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\": \"Pour obtenir la meilleure repr\u00e9sentativit\u00e9 possible tout en limitant les biais, le m\u00e9decin devait s\u00e9lectionner des patients cons\u00e9cutifs suivis pour un cancer colorectal m\u00e9tastatique et qui devaient r\u00e9pondre aux crit\u00e8res suivants : - patients \u00e2g\u00e9s de 18 ans ou plus, - patients ayant un cancer colorectal m\u00e9tastatique confirm\u00e9 histologiquement apr\u00e8s mars 2014 (date de mise \u00e0 disposition des tests NRAS dans les centres fran\u00e7ais), - les patients vus par le m\u00e9decin entre le 15 juin 2014 et le 30 septembre 2014 et qui ont d\u00e9j\u00e0 commenc\u00e9 un traitement de premi\u00e8re ligne, pendant cet intervalle de temps, pour un cancer colorectal m\u00e9tastatique - les patients pour lesquels un traitement de premi\u00e8re ligne de la maladie m\u00e9tastatique a d\u00e9j\u00e0 \u00e9t\u00e9 initi\u00e9 entre le 1er mars 2014 et le 30 juin 2014 - les patients ayant b\u00e9n\u00e9fici\u00e9 d'une visite de routine au cours de la p\u00e9riode officielle de d\u00e9pistage de 15 semaines de l'\u00e9tude.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\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&#x27;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 individus","response_rate":"N= 375 patients, inclus par 104 m\u00e9decins"},"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":"09-06-2016","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","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":"Les donn\u00e9es collect\u00e9es ont \u00e9t\u00e9 obtenues \u00e0 partir des dossiers m\u00e9dicaux des patients vus lors d'une visite pendant la p\u00e9riode de l'\u00e9tude (donn\u00e9es d\u00e9j\u00e0 enregistr\u00e9es), r\u00e9trospectivement avec un questionnaire papier et la copie du rapport de biologie mol\u00e9culaire dont toute r\u00e9f\u00e9rence au nom du patient a \u00e9t\u00e9 supprim\u00e9e pour garantir l'anonymat.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Ant\u00e9c\u00e9dents de cancer colorectal primaire ; traitement de premi\u00e8re intention d'une maladie m\u00e9tastatique ; demande de g\u00e9notypage du marqueur KRAS ; impact du r\u00e9sultat sur la prise en charge th\u00e9rapeutique.","biologicalDataDetails":"D\u00e9lai d'attente pour le r\u00e9sultat d'un test ; rapport de test de g\u00e9notypage","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}