{"doc_desc":{"title":"Etude multicentrique de la transmission nosocomiale du SRAS-CoV-2 : le projet NOSO-COR","idno":"FRESH-PEF73994-fr","producers":[{"name":"PHILIPPE VANHEMS","affiliation":"UNIVERSITE CLAUDE BERNARD LYON 1"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73994-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73994"},{"agency":"FReSH","code":"FRESH-PEF73994"}]},"title":"Etude multicentrique de la transmission nosocomiale du SRAS-CoV-2 : le projet NOSO-COR","alternate_title":"NOSO-COR-IMMUNO"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Philippe;VANHEMS","firstname":"Philippe","lastname":"VANHEMS","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/029brtt94","role":"organisation id"},{"title":"SIREN","uri":"196917744","role":"organisation id"}],"email":"philippe.vanhems@chu-lyon.fr","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","PILabo":"Fondation M\u00e9rieux, Centre International de Recherche en Infectiologie (CIRI), INSERM U1111, CNRS, UMR5308, ENS de Lyon, UCBL1, Lyon, France \/ Hospices Civils de Lyon, \/ Laboratoire des Pathog\u00e8nes Emergents \/ Service Hygi\u00e8ne, Epid\u00e9miologie, Infectiologie et Pr\u00e9vention","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"sponsor id"},{"title":"SIREN","uri":"266900273","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Philippe;VANHEMS","lastname":"VANHEMS","firstname":"Philippe","type":"contact","email":"philippe.vanhems@chu-lyon.fr","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/029brtt94","role":"organisation id","title":"ROR"},{"uri":"196917744","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[],"topics":[{"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":"Certaines maladies infectieuses ou parasitaires","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1435254666","title":"CIM-11"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"}],"purpose":"Le principal objectif de cette \u00e9tude ancillaire est de d\u00e9crire la r\u00e9ponse s\u00e9rologique chez les personnes infect\u00e9es par SARS-CoV-2 \u00e0 distance de l\u2019\u00e9pisode infectieux. Objectifs secondaires : 1. Caract\u00e9risation des populations T CD8 sp\u00e9cifiques du virus, ph\u00e9notype et capacit\u00e9 fonctionnelle, pr\u00e9sente dans la circulation (PBL) 2. Titration des anticorps neutralisants vs. facilitateurs 3. Comparaison des caract\u00e9ristiques de la r\u00e9ponse immune m\u00e9moire des patients 4. Etude de la restauration immunitaire post-COVID19 5. Constitution d'une collection d'\u00e9chantillons biologiques salivaires et sanguins aux HCL (serum et les cellules mononucl\u00e9es du sang p\u00e9riph\u00e9rique (PBMC)) et cession d'une partie des produits sanguins avant la fin de la recherche au Centre International de Recherche en Infectiologie (CIRI) pour initier des recherches pour de nouvelles connaissances scientifiques sur les agents pathog\u00e8ne SARS-CoV-2.","abstract":"","coll_dates":[{"start":"2020-01-01","end":"2021-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Auvergne Rh\u00f4ne-Alpes']","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 (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\": \"\u2022Personnes inclues dans l\u2019\u00e9tude NOSO-COR pr\u00e9sentant un diagnostic de COVID-19 confirm\u00e9 par un test biologique RT-PCR sur \u00e9couvillon nasopharyng\u00e9 sp\u00e9cifique pour le virus SARS-CoV-2 \u2022Personnes majeures \u2022Personnes qui ont \u00e9t\u00e9 d\u00fbment inform\u00e9es et qui ont sign\u00e9 le formulaire de consentement \u00e9clair\u00e9 de l\u2019\u00e9tude ancillaire \u2022Personnes affili\u00e9es \u00e0 un r\u00e9gime de s\u00e9curit\u00e9 sociale\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Donn\u00e9es r\u00e9colt\u00e9es par les m\u00e9decins en face-\u00e0-face, saisie par l\\'\u00e9quipe d\\'\u00e9pid\u00e9miologie du Pr Vanhems dans un e-CRF cr\u00e9\u00e9 par les data mangers des HCL. Donn\u00e9es analys\u00e9es par l\\'\u00e9quipe des biostatisticiens des HCL.']"}},"study_development":{"development_activity":[]},"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\":\"MeasurementsAndTests.Physical\",\"vocab\":\"CESSDA\"},\"value\":\"Mesures physiques\/biologiques (tension art\u00e9rielle, poids, biochimie, imagerie...)\"}"],"research_instrument":"","sources":[],"target_sample_size":"< 500 individus","response_rate":"189"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"","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":"----","lastUpdatedAuto":null,"lastUpdatedManual":"01-10-2021","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)"],"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":"Etude interventionnelle. Les sujets participant \u00e0 l\u2019\u00e9tude NOSO-COR au sein des Hospices Civils de Lyon et ayant \u00e9t\u00e9 diagnostiqu\u00e9s du COVID-19 ont \u00e9t\u00e9 invit\u00e9s \u00e0 participer. Deux visites ont \u00e9t\u00e9 programm\u00e9es \u00e0 environ 8 et 12 mois (\u00b1 1 mois) apr\u00e8s l\u2019\u00e9pisode infectieux initial par SARS-CoV-2. Ces visites consistaient en: la pr\u00e9sentation de l\u2019\u00e9tude ancillaire, la signature du consentement, la r\u00e9alisation des pr\u00e9l\u00e8vements sanguins, salivaire et nasopharyng\u00e9 \u00e0 chaque visite dans un centre de pr\u00e9l\u00e8vement des HCL.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Patients hospitalis\u00e9s aux Hospices Civils de Lyon"},"dataTypes":{"clinicalDataDetails":"Donn\u00e9es de la base NOSO-COR","biologicalDataDetails":"S\u00e9rologie, PCR","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}