{"doc_desc":{"title":"\u00c9tude d'une cohorte de patients atteints de cancer du poumon non \u00e0 petites cellules localement avanc\u00e9 ou m\u00e9tastatique, trait\u00e9s par Tarceva\u00ae (Erlotinib) en monoth\u00e9rapie et n'ayant pas progress\u00e9 apr\u00e8s au moins neuf mois.","idno":"FRESH-PEF74128-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74128-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74128"},{"agency":"FReSH","code":"FRESH-PEF74128"},{"agency":"NCT","code":"NCT01488331"}]},"title":"\u00c9tude d'une cohorte de patients atteints de cancer du poumon non \u00e0 petites cellules localement avanc\u00e9 ou m\u00e9tastatique, trait\u00e9s par Tarceva\u00ae (Erlotinib) en monoth\u00e9rapie et n'ayant pas progress\u00e9 apr\u00e8s au moins neuf mois.","alternate_title":"TERRA"},"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":"ERLOTINIB"}],"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":"Carcinome in situ de l'oreille moyenne ou du syst\u00e8me respiratoire","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/951191646","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":"Objectif principal : D\u00e9crire la survie sans progression d'une population de patients atteints de CPNPC m\u00e9tastatique ou localement avanc\u00e9 trait\u00e9s par Tarceva\u00ae en monoth\u00e9rapie et dont la maladie n'a pas progress\u00e9 depuis au moins neuf mois. Objectifs secondaires : - D\u00e9crire les caract\u00e9ristiques des patients \u00e0 l'inclusion dans l'\u00e9tude et \u00e0 l'initiation du traitement par Tarceva\u00ae en monoth\u00e9rapie (caract\u00e9ristiques d\u00e9mographiques, cliniques et biologiques) ; - D\u00e9crire l'utilisation de Tarceva\u00ae ; - \u00c9valuer l'efficacit\u00e9 du traitement par Tarceva\u00ae : meilleure r\u00e9ponse obtenue (r\u00e9ponse compl\u00e8te, r\u00e9ponse partielle ou stabilisation), survie globale et crit\u00e8res pronostiques de survie \u00e0 long terme sous Tarceva\u00ae ; - D\u00e9crire le profil de s\u00e9curit\u00e9 \u00e0 long terme de Tarceva\u00ae ; - D\u00e9crire les corr\u00e9lations entre la biologie des tumeurs et la r\u00e9ponse \u00e0 Tarceva\u00ae ; - D\u00e9crire l'adh\u00e9sion des patients \u00e0 la monoth\u00e9rapie par Tarceva\u00ae \u00e0 l'aide de l'\u00e9chelle de Morisky ; - D\u00e9crire l'\u00e9volution de la qualit\u00e9 de vie des patients trait\u00e9s par Tarceva\u00ae en monoth\u00e9rapie, \u00e0 l'aide du questionnaire FACT-L.","abstract":"","coll_dates":[{"start":"2010-01-01","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\": \"Crit\u00e8res d'inclusion : - Patients adultes (\u00e2ge >= 18 ans) ; - Trait\u00e9s par Tarceva\u00ae en monoth\u00e9rapie pour un CBNPC localement avanc\u00e9 ou m\u00e9tastatique (stade IIIB\\\/IV) et sans progression de la maladie depuis au moins neuf mois ; - Ayant accept\u00e9 d'\u00eatre suivi pendant toute la dur\u00e9e de l'observation (24 mois maximum) ; - Ayant re\u00e7u des informations orales et \u00e9crites sur l'\u00e9tude sans s'opposer \u00e0 ce que leurs donn\u00e9es fassent l'objet d'un traitement automatis\u00e9.  \",\n    \"clusion_E\": \"Aucun\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"['CDISC']","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\r\nConsommation 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 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\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"217"},"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":"23-06-2022","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":false,"contributorName":"Camille BACHOT","contributorAffiliation":"F. HOFFMANN-LA ROCHE AG","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":"eCRF","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Validation des crit\u00e8res de s\u00e9lection - Informations sur l'\u00e9tude - Donn\u00e9es d\u00e9mographiques et g\u00e9n\u00e9rales - Ant\u00e9c\u00e9dents de CBNPC - Biomarqueurs si disponibles - Statut de performance (ECOG) - Traitement par Tarceva\u00ae - Traitements combin\u00e9s - Traitements anticanc\u00e9reux apr\u00e8s l'arr\u00eat d\u00e9finitif de Tarceva\u00ae - Progression de la maladie - Effets ind\u00e9sirables sous traitement par Tarceva\u00ae, sur la p\u00e9riode r\u00e9trospective de l'\u00e9tude - Effets ind\u00e9sirables sur la p\u00e9riode prospective de l'\u00e9tude - Raison de l'arr\u00eat pr\u00e9matur\u00e9 de l'\u00e9tude.","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"}