{"doc_desc":{"title":"Cohorte de patients atteints d'Aspergillose Broncho Pulmonaire Allergique : \u00e9tude de la balance Th2 \/Th17","idno":"FRESH-PEF60166-fr","producers":[{"name":"Antoine MAGNAN","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60166-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60166"},{"agency":"FReSH","code":"FRESH-PEF60166"}]},"title":"Cohorte de patients atteints d'Aspergillose Broncho Pulmonaire Allergique : \u00e9tude de la balance Th2 \/Th17","alternate_title":"TARC-ABPA"},"study_authorization":{"agency":[{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Antoine;MAGNAN","PILabo":"INSERM \/ CHU DE \/ L'INSTITUT DU THORAX - INSERM UMR1087 \/ CNRS UMR 6291","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"075645300","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"201220396X","role":"labo id"}],"email":"a.magnan@hopital-foch.com","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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","email":"a.magnan@hopital-foch.com","type":"contact","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":"Aspergillose broncho-pulmonaire allergique"},{"keyword":"exacerbation"},{"keyword":"biomarqueurs"}],"topics":[{"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":"Allergologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/af65e2bf-afc5-45e8-a0fc-364dfb48f0a4"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"topic":"Aspergillose","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1913468488","title":"CIM-11"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : \u00e9valuer la pertinence de nouveaux biomarqueurs dans le suivi de l'aspergillose broncho pulmonaire allergique hors mucoviscidose (\u00e9tude des variations du NO exhal\u00e9, de l\u2019expectoration induite, de la s\u00e9rologie aspergillaire par m\u00e9thode ELISA, populations lymphocytaires).","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":"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Diagnostic d\u2019ABPA :  IGE totales sup\u00e9rieures \u00e0 417 ku\\\/lhypersensibilit\u00e9 imm\u00e9diate \u00e0 Aspergillus (prick-test positif et\\\/ou ige sp\u00e9cifiques positives) DDB proximales et\\\/ou infiltrats labiles (ABPA-S) pr\u00e9cipitines anti-aspergillaires positives Les patients pr\u00e9- inclus : - seront majeurs, de sexe indiff\u00e9rent ; - seront affili\u00e9s \u00e0 un r\u00e9gime de s\u00e9curit\u00e9 sociale ; - auront donn\u00e9 leur consentement \u00e9clair\u00e9 et \u00e9crit ; - seront porteurs d\u2019une ABPA avec tous les crit\u00e8res mentionn\u00e9s ci-dessous, pr\u00e9sents au moins 1 fois dans leur dossier m\u00e9dical ; - patients n\u2019ayant pas pr\u00e9sent\u00e9 d\u2019exacerbation depuis V0 ou V0\u2019 permettant ainsi de d\u00e9finir un \u00e9tat de base.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques Gestion des donn\u00e9es manquantes par retour au dossier source ou retour vers le patient Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi Relance des sujets pour r\u00e9aliser les visites de suivi R\u00e9alisation d\\'audits qualit\u00e9 internes 1 fois par an Proc\u00e9dures qualit\u00e9 CIC Thorax de Nantes Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es (\u00e9crit)']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"30"},"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":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques \u00e0 d\u00e9terminer Utilisation non possible des donn\u00e9es par des industriels","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"28-02-2014","isContributorPI":"Non","contributorName":"Antoine MAGNAN","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"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":"Auto-questionnaire : saisie \u00e0 partir d\u2019un questionnaire papier (saisie manuelle) avec double saisie Entretiens : saisie \u00e0 partir d\u2019un questionnaire papier (saisie manuelle) avec double saisie Examens cliniques : saisie directe informatique Examens biologiques : saisie directe informatique","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique (3 centres) fran\u00e7aise : Nantes, Angers, le Mans"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi tous les 3 mois pendant 2 ans Informations recueillies lors de l'examen clinique : historique de l'ABPA, oscultation pulmonaire, survenue des exacerbations, fonction respiratoire","biologicalDataDetails":"A chaque visite : expectoration induite (uniquement pour le centre de nantes), prise de sang (dosage IgE totales, sp\u00e9cifiques, IgG...), ECBC","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}