{"doc_desc":{"title":"Facteurs pr\u00e9dictifs de mortalit\u00e9 \u00e0 J28 des patients pris en charge au CHU de Lille pour maladie COVID 19","idno":"FRESH-PEF73660-fr","producers":[{"name":"Laurent SCHWARB","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73660-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73660"},{"agency":"FReSH","code":"FRESH-PEF73660"}]},"title":"Facteurs pr\u00e9dictifs de mortalit\u00e9 \u00e0 J28 des patients pris en charge au CHU de Lille pour maladie COVID 19","alternate_title":"LICORNE"},"study_authorization":{"agency":[{"name":"ANSM"},{"name":"Autre"}]},"authoring_entity":[{"name":"Marie-Charlotte;CHOPIN","firstname":"Marie-Charlotte","lastname":"CHOPIN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02ppyfa04","role":"organisation id"},{"title":"SIREN","uri":"265906719","role":"organisation id"}],"email":"","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","PILabo":"Lille University Hospital","isContact":false},{"name":"Laurent;SCHWARB","firstname":"Laurent","lastname":"SCHWARB","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02ppyfa04","role":"organisation id"},{"title":"SIREN","uri":"265906719","role":"organisation id"}],"email":"drs.promotion@chru-lille.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","PILabo":"Lille University Hospital - Research Division Promotion Unit","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02ppyfa04","role":"sponsor id"},{"title":"SIREN","uri":"265906719","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"UNIVERSITE DE LILLE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02kzqn938"},{"title":"SIREN","uri":"130029754"}]}]},"distribution_statement":{"contact":[{"name":"Laurent;SCHWARB","lastname":"SCHWARB","firstname":"Laurent","type":"contact","email":"drs.promotion@chru-lille.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02ppyfa04","role":"organisation id","title":"ROR"},{"uri":"265906719","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[],"topics":[{"topic":"Anesth\u00e9siologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/e92e8adc-8256-4a4c-a052-b3cad420db7d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000776"}]},{"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":"Certaines autres maladies virales","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1136802325","title":"CIM-11"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]}],"purpose":"L\u2019objectif principal de cette \u00e9tude est d\u2019identifier les facteurs pr\u00e9dictifs de mortalit\u00e9 \u00e0 J28 d\u2019infection \u00e0 SARS-CoV-2 chez les patients pris en charge pour maladie COVID 19 au CHU de Lille via la constitution d\u2019une base de donn\u00e9es \u00e9pid\u00e9miologiques, cliniques, biologiques, immunologiques, g\u00e9n\u00e9tiques, microbiologiques, anatomopathologiques, radiologiques, th\u00e9rapeutiques et consignant les r\u00e9sultats des examens d\u2019explorations fonctionnelles. NB : Seront exclus de l\u2019analyse les patients \u00ab cas confirm\u00e9s \u00bb d\u2019infection grave \u00e0 SARS-CoV-2 dont la prise en charge a \u00e9t\u00e9 r\u00e9alis\u00e9e en service de m\u00e9decine conventionnelle du fait de limitations th\u00e9rapeutiques (LAT) qui existaient pr\u00e9alablement \u00e0 l\u2019infection \u00e0 SARS-CoV-2 en raison d\u2019une pathologie incurable ou de comorbidit\u00e9s sous-jacentes.","abstract":"","coll_dates":[{"start":"2020-01-01","end":"2020-12-31"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Hauts-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\": \"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\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Tout patient majeur, \u00ab patients suspects\u00bb, \u00ab cas possibles \u00bb, \u00ab cas probables \u00bb ou \u00ab cas confirm\u00e9s \u00bb d\u2019une infection \u00e0 SARS-CoV-2 admis au CHU de Lille.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Autre']","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\r\nEv\u00e9nements de sant\u00e9\/mortalit\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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"concept\":{\"vocabURI\":\"MeasurementsAndTests.Physical\",\"vocab\":\"CESSDA\"},\"value\":\"Mesures physiques\/biologiques (tension art\u00e9rielle, poids, biochimie, imagerie...)\"}"],"research_instrument":"","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1000"},"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":"05-05-2021","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"Clinico-Biological Features and Clonal Hematopoiesis in Patients with Severe COVID-19","link":"https:\/\/pubmed.ncbi.nlm.nih.gov\/32708264\/"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"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":"Receuil retrospectif pour la 1\u00e8re vague de COVID puis prosperctif \u00e0 partir de septembre 2020","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Patients ayant consult\u00e9 ou \u00e9t\u00e9 admis au CHU de Lille pour suspicion de COVID"},"dataTypes":{"clinicalDataDetails":"ant\u00e9c\u00e9dents, sympthomatologie, donn\u00e9es pneumologiques, donn\u00e9es de monitoring de r\u00e9animation, compte rendu d'imageries, traitements et prise en charge,","biologicalDataDetails":"bilan biologique de soin courrant, diagnostic PCR, autre examens micro-biologique,","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}