{"study_desc":{"title_statement":{"idno":"FRESH-PEF60166-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60166"},{"agency":"FReSH","code":"FRESH-PEF60166"}]},"title":"Study of Th2\/Th17 balance during allergic bronchopulmonary aspergillosis","alternate_title":"TARC-ABPA"},"study_authorization":{"agency":[{"name":"CPP"}]},"authoring_entity":[{"name":"Antoine;MAGNAN","firstname":"Antoine","lastname":"MAGNAN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"uri":"075645300","role":"pi id","title":"IdRef"}],"email":"a.magnan@hopital-foch.com","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"INSERM \/ CHU DE \/ L'INSTITUT DU THORAX - INSERM UMR1087 \/ CNRS UMR 6291","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05c1qsg97","role":"sponsor id"},{"title":"SIREN","uri":"264400136","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ARS PAYS DE LA LOIRE","extlink":[{"title":"SIREN","uri":"130008006"}]},{"name":"INSTITUT DE RECHERCHE EN SANTE RESPIRATOIRE DES PAYS DE LA LOIRE (IRSBPL)","extlink":[{"title":"SIREN","uri":"528816523"}]}]},"distribution_statement":{"contact":[{"name":"Antoine;MAGNAN","lastname":"MAGNAN","firstname":"Antoine","type":"contact","email":"a.magnan@hopital-foch.com","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"allergic bronchopulmonary aspergillosis"},{"keyword":"exacerbations"},{"keyword":"biomarkers"}],"topics":[{"topic":"Pulmonary medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"D015272"}]},{"topic":"Allergology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/af65e2bf-afc5-45e8-a0fc-364dfb48f0a4"},{"title":"MeSH","uri":"D000486"}]},{"topic":"Aspergillosis","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1913468488","title":"CIM-11"}]},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"purpose":"Evaluate the relevance of new biomarkers for monitoring allergic bronchopulmonary aspergillosis : study of changes in exhaled NO, induced sputum cellularity, Aspergillus serology by ELISA method lymphocyte populations.","abstract":"","coll_dates":[{"start":"2012-01-01","end":"2014-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Pays de la Loire']","analysis_unit":"Individuals","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Young Adult (19 to 24 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adult (25 to 44 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Middle Aged (45 to 64 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}}],\"level_type_clusion_I\":\"Patients population\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"ABPA diagnostic: total IgE superior to 417 KU\/L immediat hypersensitivity to Aspergillus (positive prick-test and\/or positive specifics ige) proximal DDB (bronchiectasis) and\/or labile infiltrate (ABPA-S) positives anti-aspergillosis precipitins. Patients pre-included : legally adults, either gender; members of a social security system, obligatory informed and written consent, carriers of an ABPA with all the criteria set out hereinafter, at least once in their medical file; patients without exacerbation since V0 or V0', allowing the definition of a basic status.\",\"clusion_E\":\"\"}","data_kind":"['Clinical data','Biological data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity"}]},"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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"30"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}","notes":""},"dataset_use":{"restrictions":"Data utilization by academic teams te be determined. 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Clinical examinations : direct entry Biological examinations direct computer entry","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"French Multicentric cohort (3 centers) : Nantes, Angers, Le Mans"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"At each exam: induced expectoration (only at the Nantes center), blood sample (improved total IgE test, specifics, IgC\u2026)ECBC","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}