{"doc_desc":{"title":"Etude longitudinale sur des patients \u00e2g\u00e9s atteints de cancers bronchiques \u00e0 petites cellules : \u00e9valuation g\u00e9riatrique standardis\u00e9e et morbidit\u00e9 post-op\u00e9ratoire apr\u00e8s ex\u00e9r\u00e8se pulmonaire","idno":"FRESH-PEF6221-fr","producers":[{"name":"Christine RAYNAUD","affiliation":"GROUPE FRANCAIS DE PNEUMO-CANCEROLOGIE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF6221-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"6221"},{"agency":"FReSH","code":"FRESH-PEF6221"}]},"title":"Etude longitudinale sur des patients \u00e2g\u00e9s atteints de cancers bronchiques \u00e0 petites cellules : \u00e9valuation g\u00e9riatrique standardis\u00e9e et morbidit\u00e9 post-op\u00e9ratoire apr\u00e8s ex\u00e9r\u00e8se pulmonaire","alternate_title":"GFPC 08-05"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"name":"Christos;CHOUAID","firstname":"Christos","lastname":"CHOUAID","type":"investigator","extlink":[{"title":"SIREN","uri":"438343972","role":"organisation id"}],"email":"christos.chouaid@chicreteil.fr","affiliationName":"GROUPE FRANCAIS DE PNEUMO-CANCEROLOGIE","PILabo":"GROUPE FRANCAIS DE PNEUMO CANCEROLOGIE - GFPC - ASSOCIATION LOI 1901","isContact":true},{"name":"Christine;RAYNAUD","firstname":"Christine","lastname":"RAYNAUD","type":"investigator","extlink":[{"title":"SIREN","uri":"438343972","role":"organisation id"}],"email":"christine.raynaud@ch-argenteuil.fr","affiliationName":"GROUPE FRANCAIS DE PNEUMO-CANCEROLOGIE","PILabo":"GROUPE FRANCAIS DE PNEUMO CANCEROLOGIE - GFPC- ASSOCIATION LOI 1901","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"GROUPE FRANCAIS DE PNEUMO-CANCEROLOGIE","extlink":[{"title":"SIREN","uri":"438343972","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"GROUPE FRANCAIS DE PNEUMO-CANCEROLOGIE","extlink":[{"title":"SIREN","uri":"438343972"}]}]},"distribution_statement":{"contact":[{"name":"Christos;CHOUAID","lastname":"CHOUAID","firstname":"Christos","type":"contact","email":"christos.chouaid@chicreteil.fr","affiliationName":"GROUPE FRANCAIS DE PNEUMO-CANCEROLOGIE","contactPointLabo":"","extlink":[{"uri":"438343972","role":"organisation id","title":"SIREN"}]},{"name":"Christine;RAYNAUD","lastname":"RAYNAUD","firstname":"Christine","type":"contact","email":"christine.raynaud@ch-argenteuil.fr","affiliationName":"GROUPE FRANCAIS DE PNEUMO-CANCEROLOGIE","contactPointLabo":"","extlink":[{"uri":"438343972","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"CBNPC RESECABLE SUJET AGE PLUS DE 70 ANS EVALUATION GERIATRIQUE"}],"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":"G\u00e9riatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d37e4d8c-a978-40c7-ba4f-eee841851073"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005853"}]},{"topic":"Tumeurs malignes des bronches ou du poumon","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/316539081","title":"CIM-11"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Tester l'hypoth\u00e8se selon laquelle l'\u00e9valuation g\u00e9riatrique standardis\u00e9e constitue un facteur pronostique dans la survenue de complications post op\u00e9ratoires dans les 30 jours suivants une chirurgie d'ex\u00e9r\u00e8se pour cancer bronchique","abstract":"","coll_dates":[{"start":"2009-01-01","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\": \"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\": \"Patients \u00e2g\u00e9s de plus de 70 ans avec suspicion de CBNPC de stade clinique I \u00e0 IIIB avec indication d'ex\u00e9r\u00e8se chirurgicale \u00e0 vis\u00e9e curative retenue en RCP\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es comportementales']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['R\u00e9union de mises en place, coh\u00e9rence des donn\u00e9es de la base informatique.']"}},"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\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":"300"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"Chaque investigateur n&#x27;a acc\u00e8s qu&#x27;aux donn\u00e9es de son centre gr\u00e2ce \u00e0 un mot de passe modifi\u00e9 tous les 2 mois.","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"L&#x27;investigateur principal et le si\u00e8ge social du GFPC conserveront un CD des donn\u00e9es pendant 15 ans. Les donn\u00e9es sont recueillies par l&#x27;investigateur \u00e0 partir du dossier m\u00e9dical du patient qui a donn\u00e9 son consentement sur le cahier d&#x27;observation \u00e9lectronique. Les donn\u00e9es sont stock\u00e9es sur le serveur de la soci\u00e9t\u00e9 B&amp;D, l&#x27;analyse sera effectu\u00e9e via le logiciel SAS."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"24-05-2013","lastUpdatedAuto":null,"lastUpdatedManual":"13-06-2013","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":""},"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":"Les donn\u00e9es sont recueillies dans un cahier de recueil \u00e9lectronique saisi par chaque centre sur une base d\u00e9di\u00e9e \u00e0 cet effet.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"62 centres du GFPC - GROUPE FRANCAIS DE PNEUMO CANCEROLOGIE -"},"dataTypes":{"clinicalDataDetails":"Donn\u00e9es pr\u00e9 op\u00e9ratoires, donn\u00e9e p\u00e9ri-op\u00e9ratoires, donn\u00e9es post-op\u00e9ratoires et d'hospitalisation \u00e0 30 jours post-op\u00e9ratoire","biologicalDataDetails":"Donn\u00e9es biologiques p\u00e9ri op\u00e9ratoires","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}