{"doc_desc":{"title":"Etude de l\u2019incidence de l\u2019infection \u00e0 SARS-CoV-2 dans le d\u00e9partement des Alpes-Maritimes par l\u2019analyse de la r\u00e9ponse humorale sp\u00e9cifique et de la r\u00e9ponse cellulaire au cours du d\u00e9confinement","idno":"FRESH-PEF73574-fr","producers":[{"name":"Jonathan ALLOUCHE","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73574-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73574"},{"agency":"FReSH","code":"FRESH-PEF73574"}]},"title":"Etude de l\u2019incidence de l\u2019infection \u00e0 SARS-CoV-2 dans le d\u00e9partement des Alpes-Maritimes par l\u2019analyse de la r\u00e9ponse humorale sp\u00e9cifique et de la r\u00e9ponse cellulaire au cours du d\u00e9confinement","alternate_title":"COVIMMUNE 2"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"K\u00e9vin;ZORZI","firstname":"K\u00e9vin","lastname":"ZORZI","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05qsjq305","role":"organisation id"},{"title":"SIREN","uri":"260600705","role":"organisation id"}],"email":"zorzi.k@chu-nice.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","PILabo":"Recherche Clinique CHU de Nice","isContact":true}],"oth_id":[{"name":"D\u00e9partement de Sant\u00e9 Publique CHU Nice","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05qsjq305","role":"sponsor id"},{"title":"SIREN","uri":"260600705","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05qsjq305"},{"title":"SIREN","uri":"260600705"}]},{"name":"DEPARTEMENT DES ALPES MARITIMES","extlink":[{"title":"SIREN","uri":"220600019"}]},{"name":""}]},"distribution_statement":{"contact":[{"name":"Jonathan;ALLOUCHE","lastname":"ALLOUCHE","firstname":"Jonathan","type":"contact","email":"allouche.j@chu-nice.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05qsjq305","role":"organisation id","title":"ROR"},{"uri":"260600705","role":"organisation id","title":"SIREN"}]},{"name":"Christian;PRADIER","lastname":"PRADIER","firstname":"Christian","type":"contact","email":"pradier.c@chu-nice.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05qsjq305","role":"organisation id","title":"ROR"},{"uri":"260600705","role":"organisation id","title":"SIREN"}]},{"name":"Barbara;SEITZ-POLSKI","lastname":"SEITZ-POLSKI","firstname":"Barbara","type":"contact","email":"seitz-polski.b@chu-nice.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05qsjq305","role":"organisation id","title":"ROR"},{"uri":"260600705","role":"organisation id","title":"SIREN"}]},{"name":"K\u00e9vin;ZORZI","lastname":"ZORZI","firstname":"K\u00e9vin","type":"contact","email":"zorzi.k@chu-nice.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05qsjq305","role":"organisation id","title":"ROR"},{"uri":"260600705","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"d\u00e9confinement"},{"keyword":"interf\u00e9ron"},{"keyword":"SARS-CoV-2 COVID-19 S\u00e9rologie"},{"keyword":"immuno-virologie"},{"keyword":"incidence"}],"topics":[{"topic":"Immunologie m\u00e9dicale","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7a3cf568-46ba-4840-be8f-f22fc030139f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"topic":"Infectiologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"}],"purpose":"Mesurer l\u2019incidence de l\u2019infection \u00e0 SARS-Cov-2, sur une p\u00e9riode de 18 mois apr\u00e8s la sortie du premier confinement dans un groupe de sujets dont la profession les expose \u00e0 des contacts avec le grand public. Etablir le risque de r\u00e9infection apr\u00e8s une premi\u00e8re infection \u00e0 SARS-Cov-2 valid\u00e9e par un test s\u00e9rologique positif.","abstract":"","coll_dates":[{"start":"2020-01-01","end":"2022-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Provence - Alpes - C\u00f4te d\\'Azur']","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\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\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\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Tout sujet majeur, volontaire sain, expos\u00e9 \u00e0 du public \u00e0 partir du 11 mai 2020 inform\u00e9 de l\u2019\u00e9tude par les institutions partenaires (Conseil D\u00e9partemental 06), affili\u00e9 \u00e0 un r\u00e9gime de la s\u00e9curit\u00e9 sociale\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es paracliniques (hors biologiques) : Anthropom\u00e9trie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['V\u00e9rification de la saisie des donn\u00e9es informatiques. Data management de la base de donn\u00e9e avec tests de coh\u00e9rence. Les patients sont inform\u00e9s de l\\'utilisation de leurs donn\u00e9es.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\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) Base de population \u00e0 finalit\u00e9 statistique']"}},"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":"","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"560 environ"},"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\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","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":"15-11-2020","lastUpdatedAuto":null,"lastUpdatedManual":"01-10-2021","isContributorPI":false,"contributorName":"Jonathan ALLOUCHE","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"D\u00e9tails de l'\u00e9tude sur Clinical Trial","link":"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04429594"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"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":"Autoquestionnaire papier, entretien en face \u00e0 face, examen clinique et pr\u00e9l\u00e8vement sanguin","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Alpes-Maritimes"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l'inclusion","biologicalDataDetails":"Pr\u00e9l\u00e8vement sanguin : S\u00e9rologie IgA et IgG anti SARS-CoV2, QuantiFERON Monitor","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}