{"doc_desc":{"title":"Cohorte nationale SFCE des infections \u00e0 SARS-CoV-2 (COVID-19) en onco-h\u00e9matologie p\u00e9diatrique","idno":"FRESH-PEF73865-fr","producers":[{"name":"Elodie MORILLAND-LECOQ","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73865-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73865"},{"agency":"FReSH","code":"FRESH-PEF73865"}]},"title":"Cohorte nationale SFCE des infections \u00e0 SARS-CoV-2 (COVID-19) en onco-h\u00e9matologie p\u00e9diatrique","alternate_title":"PEDONCOVID"},"study_authorization":{"agency":[{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"J\u00e9r\u00e9mie;ROUGER-GAUDICHON","PILabo":"CHU Caen Normandie","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"261400931","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/027arzy69","role":"sponsor id"},{"title":"SIREN","uri":"261400931","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"cancer"},{"keyword":"p\u00e9diatrie"},{"keyword":"chimioth\u00e9rapie"},{"keyword":"SARS-CoV-2"},{"keyword":"COVID-19"}],"topics":[{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"Tumeurs","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]}],"purpose":"D\u00e9crire la pr\u00e9sentation et l\u2019\u00e9volution clinique de l\u2019infection \u00e0 SARS-CoV-2 chez les patients suivis en onco-h\u00e9matologie p\u00e9diatrique ou en unit\u00e9 AJA d\u2019un centre SFCE pour un cancer ou une tumeur b\u00e9nigne trait\u00e9e par chimioth\u00e9rapie, radioth\u00e9rapie ou th\u00e9rapie cibl\u00e9e.","abstract":"","coll_dates":[{"start":"","end":""}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","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\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Enfants et repr\u00e9sentants l\u00e9gaux ou patients majeurs inform\u00e9s sur l\u2019\u00e9tude ET - Patient suivi dans un centre SFCE en onco-h\u00e9matologie p\u00e9diatrique ou unit\u00e9 AJA pour un cancer ou une tumeur b\u00e9nigne trait\u00e9e par chimioth\u00e9rapie, radioth\u00e9rapie ou th\u00e9rapie cibl\u00e9e, avec un traitement oncologique en cours ou termin\u00e9 depuis moins de 6 mois ou ant\u00e9c\u00e9dent de greffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques allog\u00e9niques avec traitement immunosupresseur en cours ou interrompu depuis moins de 6 mois, ou ant\u00e9c\u00e9dent de traitement par cellules CAR-T ET - Diagnostic d\u2019infection \u00e0 SARS-CoV-2 confirm\u00e9 par une PCR ou une s\u00e9rologie IgM positive OU - Diagnostic clinique et radiologique caract\u00e9ristique d\u2019infection \u00e0 SARS-CoV-2 sans confirmation de l\u2019infection par PCR ou s\u00e9rologie IgM positive avec : o Pr\u00e9sence d\u2019au moins 2 des signes suivants si contact avec un sujet ayant une infection actuelle \u00e0 SARS-CoV-2 positive ou bien 3 des signes suivants en l\u2019absence de contact : fi\u00e8vre, toux, dysgueusie, dysosmie, myalgies, douleur thoracique, dyspn\u00e9e, signes de d\u00e9tresse respiratoire, rhinorrh\u00e9e ou encombrement rhinopharyng\u00e9, diarrh\u00e9e, c\u00e9phal\u00e9es, asth\u00e9nie d\u2019installation ou d\u2019aggravation r\u00e9cente, \u00e9ruption cutan\u00e9e. ET o Une ou des anomalie(s) radiologique(s) \u00e0 la tomodensitom\u00e9trie thoracique compatibles avec le diagnostic de COVID-19 : hyperdensit\u00e9s \u00e0 type de verre d\u00e9poli de localisation p\u00e9riph\u00e9rique et\\\/ou sous-pleurale et\\\/ou bilat\u00e9rale, \u00e9paississements intralobulaires avec aspect \u00ab crazy-paving \u00bb, condensations lin\u00e9aires avec ou sans halo p\u00e9riph\u00e9rique (signe du halo invers\u00e9).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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\":\"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":"","sources":[],"target_sample_size":"< 500 individus","response_rate":""},"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":"05-01-2021","lastUpdatedAuto":null,"lastUpdatedManual":"05-05-2021","isContributorPI":"Non","contributorName":"Elodie MORILLAND-LECOQ","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"","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":"Non"},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}