{"study_desc":{"title_statement":{"idno":"FRESH-PEF73865-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73865"},{"agency":"FReSH","code":"FRESH-PEF73865"}]},"title":"SFCE national cohort on SARS-CoV-2 (COVID-19) infections in paediatric oncology-haematology","alternate_title":"PEDONCOVID"},"study_authorization":{"agency":[{"name":"CPP"}]},"authoring_entity":[{"name":"J\u00e9r\u00e9mie;ROUGER-GAUDICHON","firstname":"J\u00e9r\u00e9mie","lastname":"ROUGER-GAUDICHON","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/027arzy69","role":"organisation id"},{"title":"SIREN","uri":"261400931","role":"organisation id"}],"email":"","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","PILabo":"CHU Caen Normandie","isContact":false}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"paediatrics"},{"keyword":"chemotherapy"},{"keyword":"SARS-CoV-2"},{"keyword":"COVID-19"}],"topics":[{"topic":"Paediatrics","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"D010372"}]},{"topic":"Neoplasms","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":"Describe the presentation and clinical course of SARS-CoV-2 infection among patients followed up in a paediatric oncology-haematology department or young adult and adolescent unit at an SFCE centre, for cancer or a benign tumour treated with chemotherapy, radiotherapy or targeted therapy.","abstract":"","coll_dates":[{"start":"","end":""}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Infant, Newborn (birth to 28 days)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D007231\"}},{\"value\":\"Infant (28 days to 2 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D007223\"}},{\"value\":\"Child, Preschool (2 to 5 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D002675\"}},{\"value\":\"Child (6 to 12 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D002648\"}},{\"value\":\"Adolescent (13 to 18 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000293\"}}],\"level_type_clusion_I\":\"Patients population\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Children and legal representatives, or adult patients having received information on the study AND - Patient followed up in a paediatric oncology-haematology department or young adult and adolescent unit at an SFCE centre for cancer or a benign tumour treated with chemotherapy, radiotherapy or targeted therapy, with a cancer treatment either ongoing or completed within the past 6\u00a0months, or a history of allogeneic haematopoietic stem cell transplantation with immunosuppressant therapy ongoing or discontinued within the past 6\u00a0months, or a history of CAR-T cell therapy AND - Diagnosis of SARS-CoV-2 infection confirmed by PCR or positive IgM serology OR - Clinical and radiological diagnosis characteristic of SARS-CoV-2 infection without confirmation of infection by PCR or positive IgM serology with: o Presence of at least 2\u00a0of the following signs in the event of contact with a subject currently presenting SARS-CoV-2 positive infection, or 3\u00a0of the following signs in the absence of contact: fever, cough, dysgeusia, dysosmia, myalgia, chest pain, dyspnoea, signs of respiratory distress, rhinorrhoea or nasopharyngeal congestion, diarrhoea, headaches, recent onset or exacerbation of asthenia and rash. AND o One or more radiological abnormalities observed on chest CT scan compatible with a diagnosis of COVID-19: peripheral and\/or subpleural and\/or bilateral ground-glass opacities, intralobular thickening with a \u0093crazy-paving\u0094 appearance, linear condensations with or without peripheral halo (reverse halo sign).\",\"clusion_E\":\"\"}","data_kind":"['Clinical data','Biological data']","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\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"","sources":[],"target_sample_size":"< 500 individuals","response_rate":""},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}","notes":""},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"05-01-2021","lastUpdatedManual":"05-05-2021","isContributorPI":"","contributorName":"","contributorAffiliation":"","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":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}