{"doc_desc":{"title":"National Prospective Cohort Follow-Up for Children with Severe Autoimmune Cytopenia","idno":"FRESH-PEF60196-en","producers":[{"name":"Yves PEREL","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60196-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60196"},{"agency":"FReSH","code":"FRESH-PEF60196"}]},"title":"National Prospective Cohort Follow-Up for Children with Severe Autoimmune Cytopenia","alternate_title":"BIOCEREVANCE 1"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Nathalie;ALADJIDI","PILabo":"CHU \/ UNIT\u00c9 D'HEMATO-ONCOLOGIE P\u00c9DIATRIQUE - CEREVANCE","affiliationName":"chu","extlink":[{"title":"ORCID","uri":"0000-0003-0231-4460","role":"pi id"},{"title":"IdRef","uri":"091935172","role":"pi id"},{"title":"SIREN","uri":"263305823","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"nathalie.aladjidi@chu-bordeaux.fr","isContact":"Yes"},{"type":"investigator","name":"Yves;PEREL","PILabo":"CHU \/ UNIT\u00c9 D'HEMATO-ONCOLOGIE P\u00c9DIATRIQUE","affiliationName":"chu","extlink":[{"title":"ORCID","uri":"0000-0001-5537-5668","role":"pi id"},{"title":"IdRef","uri":"067290124","role":"pi id"},{"title":"","uri":"","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01hq89f96","role":"sponsor id"},{"title":"SIREN","uri":"263305823","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Nathalie;ALADJIDI","email":"nathalie.aladjidi@chu-bordeaux.fr","type":"contact","affiliationName":"chu","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01hq89f96","role":"organisation id","title":"ROR"},{"uri":"263305823","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Clinical progression"},{"keyword":"prognostic factors"},{"keyword":"autoimmune haemolytic anaemia"},{"keyword":"Evans syndrome"},{"keyword":"chronic immune thrombocytopenic purpura"},{"keyword":"research network"},{"keyword":"biobank"},{"keyword":"physiopathological mechanisms of these diseases"},{"keyword":"child"}],"topics":[{"topic":"Clinical immunology","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":"Hematology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9239f328-78c9-40a5-a0b9-8e66fd9b6245"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006402"}]},{"topic":"Paediatrics","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":"Immune thrombocytopenic purpura","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/364346400","title":"CIM-11"}]},{"topic":"Autoimmune haemolytic anaemia, warm type","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/880772122","title":"CIM-11"}]},{"topic":"Evans syndrome","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1048228553","title":"CIM-11"}]}],"purpose":"General objective: To prospectively study clinical and paraclinical evolution as well as prognostic factors for autoimmune haemolytic anaemia, Evans syndrome and chronic immune thrombocytopenic purpura among children in France - To generate support for a basic and therapeutic research network for these diseases Secondary objectives - To develop a biobank to study the physiopathological mechanisms of these diseases - To generate support for a national network for epidemiological, clinical, biological and therapeutic research for these diseases","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Infant, Newborn (birth to 28 days)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Infant (28 days to 2 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Child, Preschool (2 to 5 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Under 18 years of age and affiliated with a social security scheme - Living in mainland France Patients with AIHA, chronic ITP and\\\/or ES, regardless of underlying factors Free informed written and signed consent by parental authority holders as well as the child or adolescent if they are of age\",\n    \"clusion_E\": \"constitutional haemolytic anaemia and constitutional platelet disease\"\n}","data_kind":"['Clinical data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"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\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"262"},"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\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"To be decided if data may be used by academic teams To be decided if data may be used by industrial teams","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"17-02-2015","isContributorPI":"No","contributorName":"Nathalie ALADJIDI","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.cerevance.org\/articles-scientifiques"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":"Yes"},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Clinical examinations: manual input with double data entry Biological analysis: manual input with double data entry","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Multicentric cohort throughout France (30 centres)"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"FBC, reticulocytes, blood group, rhesus, haemolysis markers (haptoglobin, LDH, total and unconjugated bilirubin), renal function, liver function test, Coombs test, MAIPA, immunoglobulin quantitation, lymphocyte phenotyping, autoantibody markers (FAN, anti-DNA, anti-phospholipid, thyroid ...), other examinations according to clinical context","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}