{"doc_desc":{"title":"\u00c9tude de cohorte de patients atteints d'un cancer du poumon non \u00e0 petites cellules (CPNPC) avanc\u00e9, non r\u00e9s\u00e9cable (stade IIIB) ou m\u00e9tastatique (stade IV), ou en rechute, commen\u00e7ant un traitement par Avastin\u00ae en association avec une chimioth\u00e9rapie en premi\u00e8re ligne de traitement de la maladie m\u00e9tastatique.","idno":"FRESH-PEF74115-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74115-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74115"},{"agency":"FReSH","code":"FRESH-PEF74115"},{"agency":"NCT","code":"NCT01333007"}]},"title":"\u00c9tude de cohorte de patients atteints d'un cancer du poumon non \u00e0 petites cellules (CPNPC) avanc\u00e9, non r\u00e9s\u00e9cable (stade IIIB) ou m\u00e9tastatique (stade IV), ou en rechute, commen\u00e7ant un traitement par Avastin\u00ae en association avec une chimioth\u00e9rapie en premi\u00e8re ligne de traitement de la maladie m\u00e9tastatique.","alternate_title":"EOLE"},"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","lastname":"Medical data center","firstname":"","type":"contact","email":"data_sharing.france@roche.com","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":"Cette \u00e9tude observationnelle \u00e9valuera la modalit\u00e9, l'efficacit\u00e9 et la s\u00e9curit\u00e9 d'Avastin (bevacizumab) en tant que traitement de premi\u00e8re ligne en association avec la chimioth\u00e9rapie chez les patients atteints d'un cancer du poumon non \u00e0 petites cellules inop\u00e9rable, avanc\u00e9, m\u00e9tastatique ou r\u00e9current, non squameux, dans la pratique clinique 1. D\u00e9crire les caract\u00e9ristiques des patients trait\u00e9s par Avastin\u00ae : caract\u00e9ristiques d\u00e9mographiques et cliniques, ant\u00e9c\u00e9dents de la maladie et troubles et conditions ant\u00e9rieurs, 2. D\u00e9crire les modalit\u00e9s d'utilisation d'Avastin\u00ae dans le cadre du suivi : doses et dur\u00e9es de traitement par Avastin\u00ae (nombre de cycles) ; traitements de chimioth\u00e9rapie utilis\u00e9s en association avec le traitement par Avastin\u00ae ; arr\u00eat du traitement par Avastin\u00ae (temporaire et d\u00e9finitif) et raisons ; strat\u00e9gies th\u00e9rapeutiques mises en place apr\u00e8s l'arr\u00eat du traitement par Avastin\u00ae, 3. D\u00e9crire la survie globale des patients trait\u00e9s par Avastin\u00ae, 4. D\u00e9crire le profil de s\u00e9curit\u00e9 du traitement par Avastin\u00ae : effets ind\u00e9sirables graves et non graves et effets ind\u00e9sirables cibl\u00e9s, 5. D\u00e9crire la qualit\u00e9 de vie : Questionnaire de qualit\u00e9 de vie de Spitzer, 6. D\u00e9crire la prise en charge th\u00e9rapeutique des patients atteints de cancer du poumon non \u00e0 cellules squameuses en premi\u00e8re ligne de chimioth\u00e9rapie en cas de maladie m\u00e9tastatique et ne recevant pas d'Avastin\u00ae : compilation d'un registre anonyme sur une p\u00e9riode de 3 mois \u00e0 partir de la date de mise en place scientifique par l'investigateur.","abstract":"","coll_dates":[{"start":"2011-01-01","end":"2013-01-01"}],"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\": \"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\": \"Cohorte prospective : - Patient adulte, homme ou femme (\u00e2ge >= 18 ans), - atteint d'un cancer du poumon non \u00e0 petites cellules (CPNPC) localement avanc\u00e9 (stade IIIB), m\u00e9tastatique (stade IV) ou r\u00e9current, non squameux (lorsque l'histologie n'est pas majoritairement de type squameux), non r\u00e9s\u00e9cable et trait\u00e9 en premi\u00e8re intention - Patient commen\u00e7ant pour la premi\u00e8re fois un traitement par bevacizumab en premi\u00e8re ligne, - Patient ayant re\u00e7u des informations orales et \u00e9crites sur l'\u00e9tude et n'ayant pas d'objection \u00e0 ce que ses donn\u00e9es personnelles fassent l'objet d'un traitement. Registre : - Patients atteints d'un cancer du poumon non \u00e0 petites cellules (CPNPC) localement avanc\u00e9 (stade IIIB), m\u00e9tastatique (stade IV) ou r\u00e9current, non squameux, non r\u00e9s\u00e9cable et trait\u00e9 en premi\u00e8re ligne, - Les patients pour lesquels le comit\u00e9 multidisciplinaire a d\u00e9cid\u00e9 de ne pas initier de traitement par bevacizumab, - L'inclusion dans le registre devait \u00eatre cons\u00e9cutive au cours des trois premiers mois de participation \u00e0 l'\u00e9tude pour chaque investigateur.\",\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":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"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":"418"},"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":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"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":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}