{"doc_desc":{"title":"Retrospective observational study taking an inventory of the KRAS test in 2011 in patients with metastatic colorectal cancer having recently started a first-line treatment","idno":"FRESH-PEF73327-en","producers":[{"name":"Juliette LONGIN","affiliation":"MERCK SANTE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73327-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73327"},{"agency":"FReSH","code":"FRESH-PEF73327"}]},"title":"Retrospective observational study taking an inventory of the KRAS test in 2011 in patients with metastatic colorectal cancer having recently started a first-line treatment","alternate_title":"Flash-KRAS"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Pierre;LAURENT-PUIG","PILabo":"","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0001-8475-5459","role":"pi id"},{"title":"IdRef","uri":"071013512","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Astrid;LIEVRE","PILabo":"","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0003-2118-717X","role":"pi id"},{"title":"IdRef","uri":"068655576","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Michel;GUIU","PILabo":"","affiliationName":"CENTRE DE PATHOLOGIE DES DOCTEURS ISABELLE BIAL - CELINE LAMBOLAIS - ALEXANDRE NATAF - JEAN PHILIPPE MOMPART, CECILE BOR","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"315932525","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Jean-Louis;MERLIN","PILabo":"","affiliationName":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"060244674","role":"pi id"},{"title":"SIREN","uri":"200042166","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Jean-Christophe;SABOURIN","PILabo":"","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE ROUEN","extlink":[{"title":"ORCID","uri":"0000-0001-5490-066X","role":"pi id"},{"title":"IdRef","uri":"075521687","role":"pi id"},{"title":"SIREN","uri":"267601680","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Pascal;ARTRU","PILabo":"","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"094607001","role":"pi id"},{"title":"SIREN","uri":"266900273","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Michel;DUCREUX","PILabo":"","affiliationName":"INSTITUT GUSTAVE ROUSSY (IGR)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"03209437X","role":"pi id"},{"title":"SIREN","uri":"775741101","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"J\u00e9r\u00f4me;VIGUIER","PILabo":"","affiliationName":"UNIVERSITE DE TOURS","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"075239604","role":"pi id"},{"title":"SIREN","uri":"193708005","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"Flash-KRAS"},{"keyword":"Colorectal cancer"}],"topics":[{"topic":"Oncology","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":"Neoplasms","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]}],"purpose":"Evaluate the KRAS test prescription rate in patients starting a first-line treatment for metastatic colorectal cancer. Secondary objectives: - Describe the potential reasons for not prescribing this test - Describe and analyse the clinical characteristics of patients and treatments planned and received in first-line metastatic treatment - Describe and analyse the time frame for obtaining the result of the KRAS test and the channel (who makes the request and when) and the therapeutic attitude adopted during this period - Analyse the impact of the availability of the KRAS test and its result on the therapeutic choice of the physician - Describe the technic used for the analysis, the type of mutation (if available) and the method for reporting the results to the clinicians (report of the results)","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Each participating centre had to select the exhaustiveness of the patients seen in consultation during the study period, meeting all of the following criteria:  - Patients aged 18 years or older,  - Patients with histologically proven metastatic colorectal cancer,  - Patients for whom a metastatic first-line treatment was initiated between 01\\\/01\\\/2011 and 27\\\/03\\\/2011,  - Patients seen in consultation during the official 2-week study selection period.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health care consumption and services"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"n=538 patients (160 centres)"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"06-06-2016","lastUpdatedAuto":null,"lastUpdatedManual":"19-10-2017","isContributorPI":"No","contributorName":"Juliette LONGIN","contributorAffiliation":"MERCK SANTE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industry"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"No","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Medical records of patients seen during the study period retrospectively and using a paper questionnaire. Anonymised copy of the molecular biology report","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"History of early colorectal cancer; First line metastatic treatment; Prescription of KRAS biomarker genotyping; impact of the result on therapeutic management","biologicalDataDetails":"Waiting period for KRAS test result; genotyping report","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}