{"doc_desc":{"title":"Longitudinal Study of Elderly Patients with Small Cell Lung Cancer: Standardised Geriatric Assessment and Postoperative Morbidity Following Lung Resection,","idno":"FRESH-PEF6221-en","producers":[{"name":"Christine RAYNAUD","affiliation":"GROUPE FRANCAIS DE PNEUMO-CANCEROLOGIE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF6221-en","IDno":{"metadata_no":[{"agency":"PEF","code":"6221"},{"agency":"FReSH","code":"FRESH-PEF6221"}]},"title":"Longitudinal Study of Elderly Patients with Small Cell Lung Cancer: Standardised Geriatric Assessment and Postoperative Morbidity Following Lung Resection,","alternate_title":"GFPC 08-05"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Christos;CHOUAID","PILabo":"GROUPE FRANCAIS DE PNEUMO CANCEROLOGIE - GFPC - ASSOCIATION LOI 1901","affiliationName":"GROUPE FRANCAIS DE PNEUMO-CANCEROLOGIE","extlink":[{"title":"ORCID","uri":"0000-0002-4290-5524","role":"pi id"},{"title":"IdRef","uri":"059755172","role":"pi id"},{"title":"SIREN","uri":"438343972","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"christos.chouaid@chicreteil.fr","isContact":"Yes"},{"type":"investigator","name":"Christine;RAYNAUD","PILabo":"GROUPE FRANCAIS DE PNEUMO CANCEROLOGIE - 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GERIATRIC ASSESSMENT- SUBJECTS OVER 70 YEARS OLD"}],"topics":[{"topic":"Oncology","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":"Geriatrics","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":"Malignant neoplasms of bronchus or lung","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/316539081","title":"CIM-11"}]},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"To test the hypothesis that standardised geriatric assessment is a prognostic factor for post-operative complications within 30 days following surgical resection for lung cancer.","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients over 70 years old with suspected NSCLC at clinical stage I  to IIIB with indication of curative surgical resection considered by multidisciplinary meeting.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data','Behavioral data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Kick-off meeting, consistent data in computerised database.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"300"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Each researcher can only access data from their centre with a password that is changed every 2 months.","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"Data are collected by the researcher from the medical record of the patient who gave their consent through the electronic case report form. Data are stored on the B&amp;D server"}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"24-05-2013","lastUpdatedAuto":null,"lastUpdatedManual":"13-06-2013","isContributorPI":"No","contributorName":"Christine RAYNAUD","contributorAffiliation":"GROUPE FRANCAIS DE PNEUMO-CANCEROLOGIE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Private non-profit"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Data are collected in an electronic case report form collected by each centre through a dedicated database.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"62 French Pneumo-Oncology Group sites throughout France"},"dataTypes":{"clinicalDataDetails":"Pre-operative data, peri-operative data and post-operative and hospitalisation data at 30 days following operation","biologicalDataDetails":"peri-operative biological data","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}