{"doc_desc":{"title":"\u00c9tude de cohorte prospective \u00e9valuant l'efficacit\u00e9 et la s\u00e9curit\u00e9 de Tarceva\u00ae en 2\u00e8me ligne chez des patients atteints de cancer du poumon non \u00e0 petites cellules (CPNPC) localement avanc\u00e9 ou m\u00e9tastatique - \u00c9tude PEPiTA","idno":"FRESH-PEF74127-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74127-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74127"},{"agency":"FReSH","code":"FRESH-PEF74127"},{"agency":"NCT","code":"NCT01659970"}]},"title":"\u00c9tude de cohorte prospective \u00e9valuant l'efficacit\u00e9 et la s\u00e9curit\u00e9 de Tarceva\u00ae en 2\u00e8me ligne chez des patients atteints de cancer du poumon non \u00e0 petites cellules (CPNPC) localement avanc\u00e9 ou m\u00e9tastatique - \u00c9tude PEPiTA","alternate_title":"PEPITA"},"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 (SSP) chez les patients atteints d'un CBNPC malpighien de stade IIIB ou IV commen\u00e7ant un traitement par Tarceva\u00ae apr\u00e8s l'\u00e9chec d'une chimioth\u00e9rapie de premi\u00e8re intention \u00e0 base de sels de platine. Objectifs secondaires : - D\u00e9crire les caract\u00e9ristiques des patients trait\u00e9s par Tarceva\u00ae ; - D\u00e9crire les modalit\u00e9s de traitement par Tarceva\u00ae chez les patients atteints de CBNPC malpighien apr\u00e8s \u00e9chec d'une chimioth\u00e9rapie de premi\u00e8re intention \u00e0 base de sels de platine ; - \u00c9valuer la survie globale ; - D\u00e9crire l'\u00e9volution de la qualit\u00e9 de vie ; - D\u00e9crire le profil de s\u00e9curit\u00e9 de Tarceva\u00ae.","abstract":"","coll_dates":[{"start":"2012-01-01","end":"2014-01-01"}],"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 : 1. Patients adultes (\u00e2ge >= 18 ans) ; 2. CBNPC avanc\u00e9 (stade IIIB) ou m\u00e9tastatique (stade IV) confirm\u00e9 histologiquement et\\\/ou cytologiquement avec une composante malpighienne pr\u00e9dominante (les carcinomes basalo\u00efdes sont accept\u00e9s), apr\u00e8s \u00e9chec d'une chimioth\u00e9rapie de premi\u00e8re intention \u00e0 base de sels de platine ; 3. Pour lesquels le m\u00e9decin traitant a d\u00e9cid\u00e9 d'initier un traitement par Tarceva\u00ae ; 4. Ayant re\u00e7u des informations orales et \u00e9crites sur l'\u00e9tude et n'ayant pas soulev\u00e9 d'objection \u00e0 la collecte et \u00e0 l'analyse de ses donn\u00e9es personnelles.  \",\n    \"clusion_E\": \"1 Carcinome pulmonaire mixte non \u00e0 petites cellules et \u00e0 petites cellules ou carcinome \u00e9pidermo\u00efde mixte avec une composante ad\u00e9nocarcinome pr\u00e9dominante ; 2 Participation concomitante \u00e0 un essai clinique \u00e9valuant un traitement antin\u00e9oplasique\"\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\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"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":"152"},"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":"Date de la visite - Crit\u00e8res d'inclusion\/d'exclusion - Donn\u00e9es d\u00e9mographiques - indice ECOG - pression art\u00e9rielle systolique (PAS) et pression art\u00e9rielle diastolique (PAD) - Donn\u00e9es sociales et professionnelles - Facteurs de risque (tabagisme) - Ant\u00e9c\u00e9dents m\u00e9dicaux et maladies concomitantes - Traitement associ\u00e9 \u00e0 l'initiation de Tarceva\u00ae - Ant\u00e9c\u00e9dents de la maladie : \u00e9valuation de la tumeur pulmonaire primaire - Ant\u00e9c\u00e9dents de la maladie : diagnostic d'une maladie localement avanc\u00e9e ou m\u00e9tastatique - Statut mutationnel de l'EGFR - Traitement de premi\u00e8re intention du CBNPC m\u00e9tastatique.","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"}