{"doc_desc":{"title":"Etude de la r\u00e9ponse s\u00e9rologique contre le virus SARS-CoV-2 dans 2 types de personnel, hospitalier et non hospitalier, \u00e0 l\u2019Institut Curie et \u00e0 l\u2019Institut Pasteur","idno":"FRESH-PEF73954-fr","producers":[{"name":"","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73954-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73954"},{"agency":"FReSH","code":"FRESH-PEF73954"},{"agency":"NCT","code":"NCT04369066"}]},"title":"Etude de la r\u00e9ponse s\u00e9rologique contre le virus SARS-CoV-2 dans 2 types de personnel, hospitalier et non hospitalier, \u00e0 l\u2019Institut Curie et \u00e0 l\u2019Institut Pasteur","alternate_title":"Curiosa"},"study_authorization":{"agency":[{"name":"Autre"}]},"authoring_entity":[{"name":"Olivier;LANTZ","firstname":"Olivier","lastname":"LANTZ","type":"investigator","extlink":[{"title":"","uri":"","role":"organisation id"}],"email":"0000-0003-3161-7719","affiliationName":"","PILabo":"","isContact":true},{"name":"Thierry;ROSE","firstname":"Thierry","lastname":"ROSE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0495fxg12","role":"organisation id"},{"title":"SIREN","uri":"775684897","role":"organisation id"}],"email":"","affiliationName":"INSTITUT PASTEUR","PILabo":"","isContact":false}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT CURIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04t0gwh46","role":"sponsor id"},{"title":"SIREN","uri":"784257166","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Olivier;LANTZ","lastname":"LANTZ","firstname":"Olivier","type":"contact","email":"0000-0003-3161-7719","affiliationName":null,"contactPointLabo":"","extlink":[]}]},"study_info":{"keywords":[],"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 comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"L\u2019objectif de cette \u00e9tude est de constituer une s\u00e9roth\u00e8que prospective permettant l\u2019\u00e9tude de la pr\u00e9valence et de la qualit\u00e9 de la r\u00e9ponse immune s\u00e9rologique dirig\u00e9e contre le virus SARS-CoV-2 au cours de la pand\u00e9mie dans une population active en dehors de tout \u00e9pisode infectieux aigu par le SARS-CoV-2, le personnel de l'Institut Curie (Si\u00e8ge, H\u00f4pital et Centre de Recherche) et le personnel de l\u2019Institut Pasteur ayant potentiellement divers niveaux d'exposition.","abstract":"","coll_dates":[{"start":"","end":""}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France']","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\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"1) Personne, volontaire en dehors de tout \u00e9pisode infectieux aigu par le SARS-CoV-2 * (cf. paragraphe indication), et en capacit\u00e9 d\u2019exercer son activit\u00e9 professionnelle sur un des 3 sites de l\u2019Institut Curie, Paris, Orsay ou Saint Cloud, ou sur le campus de l\u2019Institut Pasteur. 2) Personne \u00e2g\u00e9e de 18 ans ou plus. 3) Information et consentement de la personne aux proc\u00e9dures li\u00e9es \u00e0 l\u2019\u00e9tude (cf. note d\u2019information \\\/ consentement). 4) A partir de novembre 2020, personne ayant pr\u00e9sent\u00e9 au moins un des crit\u00e8res suivants depuis janvier 2020 : \u2013 Un test de diagnostic du SARS-COV-2 positif par PCR sur pr\u00e9l\u00e8vement naso-pharyng\u00e9 ou test antig\u00e9nique, \u2013 Une s\u00e9rologie SARS-CoV-2 positive, \u2013 Une anosmie ou\\\/et une agueusie, \u2013 Une infection respiratoire** associ\u00e9e \u00e0 des signes digestifs** Pour le personnel exer\u00e7ant \u00e0 l\u2019Institut Pasteur, Quelles que soient les modalit\u00e9s de travail pendant le confinement. :  Personne ayant pr\u00e9sent\u00e9 au moins un des crit\u00e8res suivants depuis janvier 2020 : \u2013 Un test de diagnostic du SARS-COV-2 positif par PCR sur pr\u00e9l\u00e8vement naso-pharyng\u00e9, \u2013 Une s\u00e9rologie SARS-CoV-2 positive, \u2013 Une anosmie ou\\\/et une agueusie, \u2013 Une infection respiratoire** associ\u00e9e \u00e0 des signes digestifs**  *Sont consid\u00e9r\u00e9s comme volontaires ne pr\u00e9sentant pas d'infection active par le SARS-CoV-2 au moment de l\u2019inclusion : personnes n\u2019ayant pas de signes cliniques** \u00e9vocateurs d\u2019une infection \u00e0 SARS-CoV-2 au moment du pr\u00e9l\u00e8vement sanguin ou les ayant eu avec une fin des sympt\u00f4mes depuis plus de 7 jours.  ** fi\u00e8vre, fatigue, toux, g\u00eane respiratoire, essoufflement, perte de gout ou odorat, maux de t\u00eate, courbatures, conjonctivite ou rhume, troubles digestifs (vomissement, diarrh\u00e9e), que les signes aient entrain\u00e9 ou non un arr\u00eat de travail, un traitement et\\\/ou une hospitalisation.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","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"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\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":"[1000-10000[ individus","response_rate":"1900"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study 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Richard-Le Goff O, Choucha Z, Helynck O, Janin YL, Escriou N, Charneau P, Perez F, Rose T, Lantz O.. 2021. High seroprevalence but short-lived immune response to SARS-CoV-2 infection in Paris. Eur J Immunol. Dec 1:10.1002\/eji.202049058","link":"doi: 10.1002\/eji.202049058."},{"type":"","title":"Anna F, Goyard S, Lalanne AI, Nevo F, Gransagne M, Souque P, Louis D, Gillon V, Turbiez I, Bidard FC, Gobillion A, Savignoni A, Guillot-Delost M, Dejardin F, Dufour E, Petres S, Richard-Le Goff O, Choucha Z, Helynck O, Janin YL, Escriou N, Charneau P, Perez F, Rose T, Lantz O.. 2021. High seroprevalence but short-lived immune response to SARS-CoV-2 infection in Paris. Eur J Immunol. Dec 1:10.1002\/eji.202049058","link":"doi: 10.1002\/eji.202049058"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":false},"collaborations":{"networkConsortium":""},"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":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"\u00cele-de-France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}