{"doc_desc":{"title":"Observational, retrospective study exploring RAS mutation tests practices in patients with metastatic colorectal cancer in 2014","idno":"FRESH-PEF73329-en","producers":[{"name":"Juliette LONGIN","affiliation":"MERCK SANTE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73329-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73329"},{"agency":"FReSH","code":"FRESH-PEF73329"}]},"title":"Observational, retrospective study exploring RAS mutation tests practices in patients with metastatic colorectal cancer in 2014","alternate_title":"Flash-RAS"},"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":"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"}],"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":"RAS mutation tests"},{"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":"To assess the RAS (KRAS and NRAS exons 2,3 and 4) mutation screening test request and realisation rates in patients with a recent diagnosis of metastatic colorectal cancer. Secondary objectives: - To describe changes in the KRAS (exon 2) mutation test request rate between 2011 and 2014; - To describe the reasons for requesting\/not requesting and performing\/not performing these tests as a function of physician and patient profiles - To describe and to analyse the impact of KRAS (exons 2,3 and 4) and NRAS (exons 2.3 and 4) results, the anatomopathology department availability to provide the tests, and the BRAF result, on therapeutic decision-making or changes in ongoing treatment; - To describe and analyse clinical characteristics of patients and treatments planned and received as first-line therapy of metastatic disease; - To describe the laboratory test method, the type of mutation request (if available) and the method and route by which the result was communicated to the physicians (result report); - To describe and to analyse the time to receipt the KRAS and NRAS results, the process (who ordered the test and when) and the therapeutic approach chosen during this period","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":"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\": \"To obtain the best possible representativeness while limiting bias, the physician had to screen consecutive patients followed for metastatic colorectal cancer and who had to satisfy the following criteria: - patients 18 years of age or older, - patients with metastatic colorectal cancer histologically-confirmed after march 2014 (date the NRAS tests become available in French centers), - patients seen by the physician between June 15th , 2014 and September 30th, 2014 who have already started first-line treatment, during that time interval, for mCRC - patients in whom first-line therapy of metastatic disease had been already initiated between March 1st, 2014 and June 30th, 2014 - patients seen in a routine visit during the official 15-week screening period of the study\",\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 individuals","response_rate":"N= 375 patients, included by 104 physicians"},"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":"09-06-2016","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","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":"Data collected were obtained from the medical notes of patients seen at a visit during the study period (data already recorded), restrospectively with a paper questionnaire and the copy of the molecular biology report from which all reference to the patient by name had been removed to be anonymous","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"History of primary colorectal cancer; first-line therapy of metastatic disease; request for KRAS marker genotyping; impact of result on therapeutic management","biologicalDataDetails":"Waiting period for test result; genotyping test 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"}