{"doc_desc":{"title":"Cohorte de patients greff\u00e9s avec les cellules du sang de cordon ombilical atteints de maladies h\u00e9matologiques malignes et non malignes","idno":"FRESH-PEF60097-fr","producers":[{"name":"Vanderson ROCHA","affiliation":"UNIVERSITE PARIS CITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60097-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60097"},{"agency":"FReSH","code":"FRESH-PEF60097"}]},"title":"Cohorte de patients greff\u00e9s avec les cellules du sang de cordon ombilical atteints de maladies h\u00e9matologiques malignes et non malignes","alternate_title":"EUROCORD"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Vanderson;ROCHA","PILabo":"INSTITUT UNIVERSITAIRE D\u2019 HEMATOLOGIE- UNIVERSITE DE PARIS \/ EUROCORD- OFFICE DE RECHERCHE CLINIQUE EN HEMATOLOGIE ET IMMUNODEFICIENCE","affiliationName":"UNIVERSITE PARIS CITE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"154693790","role":"pi id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"rocha.vanderson@hotmail.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"UNIVERSITE PARIS CITE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05f82e368","role":"sponsor id"},{"title":"SIREN","uri":"130025737","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE DE LA BIOMEDECINE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03tajza86"},{"title":"SIREN","uri":"180092587"}]},{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14"},{"title":"SIREN","uri":"267500452"}]}]},"distribution_statement":{"contact":[{"name":"Vanderson;ROCHA","email":"rocha.vanderson@hotmail.fr","type":"contact","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"prise du greffon"},{"keyword":"r\u00e9action"},{"keyword":"greffon contre l\u2019h\u00f4te"},{"keyword":"aigue"},{"keyword":"chronique"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"rechute"},{"keyword":"mortalit\u00e9"}],"topics":[{"topic":"Cardiologie et m\u00e9decine vasculaire","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4455c187-2f2f-4cd1-a4dd-449f59d73b39"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D002309"}]},{"topic":"H\u00e9matologie","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":"Tumeurs h\u00e9matopo\u00ef\u00e9tiques malignes, sans autre pr\u00e9cision","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1510618119","title":"CIM-11"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : Collecter des donn\u00e9es cliniques des nouveaux patients greff\u00e9s et mise \u00e0 jour du suivi de la cohorte pour l\u2019analyse des facteurs pronostiques des r\u00e9sultats des greffes en Europe et dans le monde avec une ou deux unit\u00e9s de sang de cordon provenant des banques de sang de cordon fran\u00e7aises, europ\u00e9ennes ou internationales. Objectif secondaire : Am\u00e9liorer la r\u00e9cup\u00e9ration de donn\u00e9es par la creation d\u2019un syst\u00e8me electronique de recueil de donn\u00e9es en ligne pour les banques de sang de cordon, afin de faciliter le flux d\u2019informations qui provient de ces banques et permettre de r\u00e9cuperer des donn\u00e9es non analys\u00e9es \u00e0 ce jour. Restructurer le syst\u00e8me d\u2019information actuel, notamment gr\u00e2ce au d\u00e9veloppement de nouvelles technologies pour la gestion de la base de donn\u00e9es et l\u2019application des standards internationaux. D\u00e9velopper un r\u00e9seau de communication \u00e9lectronique avec d\u2019autres bases de donn\u00e9es existantes notamment avec promise (registre EBMT des greffes de moelle), Netcord (r\u00e9seau des banques), le NMDP et le CIBMTR aux USA.","abstract":"","coll_dates":[{"start":"1998-01-01"}],"nation":[{"name":"Royaume-Uni","abbreviation":"gb","extLink":{"vocab":"ISO","vocabURI":"gb"}},{"name":"Su\u00e8de","abbreviation":"se","extLink":{"vocab":"ISO","vocabURI":"se"}},{"name":"Norv\u00e8ge","abbreviation":"no","extLink":{"vocab":"ISO","vocabURI":"no"}},{"name":"Allemagne","abbreviation":"de","extLink":{"vocab":"ISO","vocabURI":"de"}},{"name":"Italie","abbreviation":"it","extLink":{"vocab":"ISO","vocabURI":"it"}},{"name":"Espagne","abbreviation":"es","extLink":{"vocab":"ISO","vocabURI":"es"}},{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Belgique","abbreviation":"be","extLink":{"vocab":"ISO","vocabURI":"be"}},{"name":"Congo","abbreviation":"cg","extLink":{"vocab":"ISO","vocabURI":"cg"}},{"name":"Islande","abbreviation":"is","extLink":{"vocab":"ISO","vocabURI":"is"}},{"name":"Danemark","abbreviation":"dk","extLink":{"vocab":"ISO","vocabURI":"dk"}}],"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\": \"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Tous les patients ayant re\u00e7u une ou deux unit\u00e9s de sang de cordon ombilical en Europe ou patients internationaux ayant re\u00e7u une ou deux unit\u00e9s de sang de cordon provenant des banques europ\u00e9ennes\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques Gestion des donn\u00e9es manquantes par retour au dossier source ou retour vers un tiers ou retour vers la base ebmt (promise) pour confirmer l\u2019absence des donnees et ainsi pouvoir retourner vers les data-managers des centres greffeurs Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es']"}},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"4724"},"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\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation possible des donn\u00e9es par des industriels \u00e0 d\u00e9terminer","conditions":"Condition d'acc\u00e8s determiner par le conseil scientifique d\u2019eurocord, de la societe fran\u00e7aise de greffe de moelle (sfgm-tc), de l\u2019ebmt Condition d'acc\u00e8s contrats avec les biotech et l'industrie pharmaceutiques en discussion, aucun n'est actuellement actif","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"20-08-2014","isContributorPI":"Non","contributorName":"Vanderson ROCHA","contributorAffiliation":"UNIVERSITE PARIS CITE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/24986801"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Informations recueillies par l'autre fiche d'information : questionnaire papier et par internet (remplis par banques de sang de cordon et data managers des centres greffeurs)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique (418 centres) Internationale impliquant : 50 PAYS : EUROPE, USA, AMERIQUE DU SUD, AUSTRALIE, JAPON"},"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"}