{"doc_desc":{"title":"Strat\u00e9gies th\u00e9rapeutiques incluant l'Avastin comme traitement de premi\u00e8re ligne chez les patients \u00e2g\u00e9s souffrant d'un cancer du poumon non \u00e0 petites cellules non squameux avanc\u00e9 (stade IIIB\/IV), dans la pratique clinique courante","idno":"FRESH-PEF74114-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74114-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74114"},{"agency":"FReSH","code":"FRESH-PEF74114"},{"agency":"NCT","code":"NCT01893268"}]},"title":"Strat\u00e9gies th\u00e9rapeutiques incluant l'Avastin comme traitement de premi\u00e8re ligne chez les patients \u00e2g\u00e9s souffrant d'un cancer du poumon non \u00e0 petites cellules non squameux avanc\u00e9 (stade IIIB\/IV), dans la pratique clinique courante","alternate_title":"AVANTAGE"},"study_authorization":{"agency":[{"name":"Autre"}]},"authoring_entity":[],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":";Medical data center","email":"data_sharing.france@roche.com","type":"contact","affiliationName":"F. HOFFMANN-LA ROCHE AG","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01mqmer16","role":"organisation id","title":"ROR"},{"uri":"775752140","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Bevacizumab"}],"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":"Dans chaque cohorte de patients d\u00e9finis par leur classe d'\u00e2ge ([65 ; 70[ et >=70 ans), les crit\u00e8res d'\u00e9valuation sont les suivants : - Agents antin\u00e9oplasiques associ\u00e9s au bevacizumab en traitement de premi\u00e8re intention - Classes d'agents antin\u00e9oplasiques associ\u00e9s au b\u00e9vacizumab en traitement de premi\u00e8re intention (sels de platine, taxanes, etc.) - Soins de soutien (facteurs de croissance, analg\u00e9siques). \u00e0 d\u00e9crire : -Caract\u00e9ristiques des patients atteints d'un carcinome pulmonaire non \u00e0 petites cellules non squameux avanc\u00e9 (nsNSCLC) trait\u00e9s par b\u00e9vacizumab en premi\u00e8re ligne de traitement, ainsi que les caract\u00e9ristiques de leur maladie, - Survie sans progression (SSP) et survie globale (SG), - \u00c9volution de la qualit\u00e9 de vie des patients au cours de la p\u00e9riode de traitement par le bevacizumab en premi\u00e8re intention, - S\u00e9curit\u00e9 du bevacizumab, - Raisons de la non-utilisation du bevacizumab comme traitement de premi\u00e8re intention chez les patients souffrant d'un cancer du poumon non \u00e0 petites cellules \u00e0 un stade avanc\u00e9.","abstract":"","coll_dates":[{"start":"2013-01-01","end":"2017-01-01"}],"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\": \"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\": \"Crit\u00e8res d'inclusion : - Patient \u00e2g\u00e9 de >= 65 ans, - Diagnostiqu\u00e9 avec un carcinome pulmonaire non \u00e0 petites cellules non squameux (CBNPC) avanc\u00e9 (stade IIIB ou IV), - Pour lequel le m\u00e9decin a d\u00e9cid\u00e9 d'initier un traitement par bevacizumab associ\u00e9 \u00e0 une chimioth\u00e9rapie en 1\u00e8re ligne, - Ayant re\u00e7u des informations orales et \u00e9crites sur l'\u00e9tude, et ayant sign\u00e9 un formulaire de consentement \u00e9crit.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Bonnes pratiques cliniques\/Bonnes Pratiques de Pharmacovigilance (GCP\/GVP)']"}},"study_development":{"development_activity":[]},"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\"}","{\"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":"277"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"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":"17-01-2022","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":"Non","contributorName":"Camille BACHOT","contributorAffiliation":"F. HOFFMANN-LA ROCHE AG","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Validation des crit\u00e8res de s\u00e9lection ; Information sur l'\u00e9tude et formulaire de consentement \u00e9crit ; Donn\u00e9es d\u00e9mographiques et g\u00e9n\u00e9rales ; Historique de la maladie ; Traitement par Bevacizumab ; Indice G8 et indice de comorbidit\u00e9 de Charlson, le cas \u00e9ch\u00e9ant ; R\u00e9ponse au traitement de premi\u00e8re ligne ; Traitements combin\u00e9s ; Premi\u00e8re progression de la maladie ; R\u00e9sultats rapport\u00e9s par les patients ; Raison de l'abandon ; Ev\u00e9nements ind\u00e9sirables.","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}