{"doc_desc":{"title":"Cohorte de patients atteints d'un cancer bronchique pulmonaire primitif","idno":"FRESH-PEF73306-fr","producers":[{"name":"Grimaux MICHEL","affiliation":"GRAND HOPITAL DE L EST FRANCILIEN (GHEF)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73306-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73306"},{"agency":"FReSH","code":"FRESH-PEF73306"}]},"title":"Cohorte de patients atteints d'un cancer bronchique pulmonaire primitif","alternate_title":"KBP-CPHG"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Michel;GRIVAUX","PILabo":"Meaux Hospital \/ Pulmonology","affiliationName":"GRAND HOPITAL DE L EST FRANCILIEN (GHEF)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"084261285","role":"pi id"},{"title":"SIREN","uri":"200063477","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"m-grivaux@ch-meaux.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"COLLEGE PNEUMOLOGUES HOPITAUX GENERAUX (CPHG)","extlink":[{"title":"SIREN","uri":"413350554","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ASTRAZENECA (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016qv5070"},{"title":"SIREN","uri":"558201075"}]},{"name":"BOEHRINGER INGELHEIM INTERNATIONAL GMBH","extlink":[{"title":"SIREN","uri":"508241882"}]},{"name":"CHUGAI PHARMA FRANCE","extlink":[{"title":"SIREN","uri":"435074422"}]},{"name":"COLLEGE PNEUMOLOGUES HOPITAUX GENERAUX (CPHG)","extlink":[]},{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140"}]},{"name":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87"},{"title":"SIREN","uri":"592052146"}]},{"name":"LILLY FRANCE","extlink":[{"title":"SIREN","uri":"609849153"}]},{"name":"PFIZER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"},{"title":"SIREN","uri":"433623550"}]},{"name":"PIERRE FABRE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04hdhz511"}]},{"name":"RECHERCHE EN SANTE RESPIRATOIRE (FOND DE DOTATION)","extlink":[{"title":"SIREN","uri":"521979674"}]},{"name":"SANOFI (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837"},{"title":"SIREN","uri":"395030844"}]},{"name":"SARL PNEUMOLOGIE DEVELOPPEMENT","extlink":[{"title":"SIREN","uri":"410753727"}]}]},"distribution_statement":{"contact":[{"name":"Michel;GRIVAUX","email":"m-grivaux@ch-meaux.fr","type":"contact","affiliationName":"GRAND HOPITAL DE L EST FRANCILIEN (GHEF)","contactPointLabo":"","extlink":[{"uri":"200063477","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"H\u00f4pitaux g\u00e9n\u00e9raux"},{"keyword":"Prise en charge du patient"},{"keyword":"ad\u00e9nocarcinome"},{"keyword":"\u00c9pid\u00e9miologie"},{"keyword":"cancer bronchopulmonaire (CBP)"}],"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":"Pneumologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D015272"}]},{"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 biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"L'objectif principal est d\u2019\u00e9tudier la mortalit\u00e9 \u00e0 5 ans de ces patients et les facteurs de risque. Ses objectifs secondaires sont : \u2022 de d\u00e9crire les caract\u00e9ristiques de cette population de patients, de leur cancer et les modalit\u00e9s de leur prise en charge ; \u2022 d\u2019estimer les taux de survie \u00e0 1, 4 et 5 ans ; \u2022 de comparer les donn\u00e9es obtenues \u00e0 celles de l\u2019\u00e9tude KBP-2000-CPHG (m\u00eame type d\u2019\u00e9tude, m\u00eames modalit\u00e9s de recrutement des centres et des patients, m\u00eame crit\u00e8res d\u2019inclusion des patients, et nombreux items communs dans les deux questionnaires)","abstract":"","coll_dates":[{"start":"2000-01-01","end":"2010-01-01"}],"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\": \"Tous les patients avec un CBP diagnostiqu\u00e9s histologiquement ou cytologiquement entre le 1er janvier et le 31 d\u00e9cembre 2000 et le 1er janvier et le 31 d\u00e9cembre 2010. Patients suivis dans l\u2019un des services de pneumologie volontaires des centres hospitaliers g\u00e9n\u00e9raux (CHG)\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}","{\"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":"[10000-20000[ individus","response_rate":"2000 : 4669 ; 2010 : 7051"},"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":"Contacter le responsable scientifique","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":"21-01-2016","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2020","isContributorPI":"Non","contributorName":"Michel GRIVAUX","contributorAffiliation":"GRAND HOPITAL DE L EST FRANCILIEN (GHEF)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=KBP+AND+CPHG"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie","Industrie","Industrie","Autre","Industrie","Industrie","Industrie","Industrie","Industrie","Autre","Industrie","Autre"],"otherFundingAgentType":["","","","","","","","","","","",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Par les m\u00e9decins particpants","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Les modalit\u00e9s du diagnostic du CBP (recrutement, sympt\u00f4mes, radiographie, m\u00e9thode et lieu du pr\u00e9l\u00e8vement ayant permis le diagnostic, date du diagnostic, examen anatomopathologique) ; son \u00e9tat fonctionnel gr\u00e2ce au score obtenu au Performance Status (PS) ; le type histologique du CBP selon la classification de l\u2019Organisation Mondiale de la Sant\u00e9 et obtenu \u00e0 partir des r\u00e9sultats histologiques ou cytologiques (cancer \u00e0 petites cellules, ad\u00e9nocarcinome, \u00e9pidermo\u00efde, carcinome \u00e0 grandes cellules, cancer bronchiolo-alv\u00e9olaire) ; le stade du cancer au moment du diagnostic en se basant sur la classification clinique Tumor-Node-Metastasis [TNM] pour les CBNPC selon les crit\u00e8res de Mountain ; la strat\u00e9gie th\u00e9rapeutique de premi\u00e8re intention choisie par son m\u00e9decin","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}