{"doc_desc":{"title":"Follow-up of a cohort of patients who received umbilical cord blood transplantation with malignant and non-malignant haematological diseases","idno":"FRESH-PEF60097-en","producers":[{"name":"Vanderson ROCHA","affiliation":"UNIVERSITE PARIS CITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60097-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60097"},{"agency":"FReSH","code":"FRESH-PEF60097"}]},"title":"Follow-up of a cohort of patients who received umbilical cord blood transplantation with malignant and non-malignant haematological diseases","alternate_title":"EUROCORD"},"study_authorization":{"agency":[]},"authoring_entity":[{"name":"Vanderson;ROCHA","firstname":"Vanderson","lastname":"ROCHA","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05f82e368","role":"organisation id"},{"title":"SIREN","uri":"130025737","role":"organisation id"}],"email":"rocha.vanderson@hotmail.fr","affiliationName":"UNIVERSITE PARIS CITE","PILabo":"INSTITUT UNIVERSITAIRE D\u2019 HEMATOLOGIE- UNIVERSITE DE PARIS \/ EUROCORD- OFFICE DE RECHERCHE CLINIQUE EN HEMATOLOGIE ET IMMUNODEFICIENCE","isContact":true}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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","lastname":"ROCHA","firstname":"Vanderson","type":"contact","email":"rocha.vanderson@hotmail.fr","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":"engraftment"},{"keyword":"reaction"},{"keyword":"graft against the host"},{"keyword":"acute"},{"keyword":"chronic"},{"keyword":"Health episodes"},{"keyword":"relapse"},{"keyword":"mortality"}],"topics":[{"topic":"Cardiology and vascular medicine","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":"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":"Malignant haematopoietic neoplasms without further specification","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1510618119","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"General objective: To collect clinical data for new transplant patients and updating cohort follow-up for analysis of prognostic factors from transplantation results in Europe and globally with one or two units of cord blood from umbilical cord blood banks located in France, Europe or internationally. Secondary Objective: To improve data recovery through the creation of an electronic system for collecting data online for cord blood banks in order to facilitate the flow of information from these banks and allow the retrieval of non-analysed to date. To restructure the current information system, notably thanks to the development of new technologies for database management and the application of international standards. To develop a network of electronic communication with other existing databases with PROMISE (EBMT register for bone marrow transplants), Netcord (bank network), the NMDP and CIBMTR in the USA.","abstract":"","coll_dates":[{"start":"1998-01-01"}],"nation":[{"name":"United Kingdom","abbreviation":"gb","extLink":{"vocab":"ISO","vocabURI":"gb"}},{"name":"Sweden","abbreviation":"se","extLink":{"vocab":"ISO","vocabURI":"se"}},{"name":"Norway","abbreviation":"no","extLink":{"vocab":"ISO","vocabURI":"no"}},{"name":"Germany","abbreviation":"de","extLink":{"vocab":"ISO","vocabURI":"de"}},{"name":"Italy","abbreviation":"it","extLink":{"vocab":"ISO","vocabURI":"it"}},{"name":"Spain","abbreviation":"es","extLink":{"vocab":"ISO","vocabURI":"es"}},{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Belgium","abbreviation":"be","extLink":{"vocab":"ISO","vocabURI":"be"}},{"name":"Congo","abbreviation":"cg","extLink":{"vocab":"ISO","vocabURI":"cg"}},{"name":"Iceland","abbreviation":"is","extLink":{"vocab":"ISO","vocabURI":"is"}},{"name":"Denmark","abbreviation":"dk","extLink":{"vocab":"ISO","vocabURI":"dk"}}],"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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"All patients who received one or two units of umbilical cord blood in Europe or international patients who received one or two units of cord blood from European banks\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Participant-reported health 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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"4724"},"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":"Data may be used by academic teams . To be defined if data may be used by industrial teams.","conditions":"Access determined by the Eurocord Scientific Council, The French Stem Cell Society (sfgm-tc) and EBMT.Contractual access with Biotech and pharmaceutical industry in discussion, but not currently active","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":"20-08-2014","isContributorPI":false,"contributorName":"","contributorAffiliation":"","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":""},"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":"Information gathered by another information record: paper questionnaire and on-line (completed by cord blood banks and data managers or transplant centres)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"International multicentric cohort (418 centres) involving: 50 COUNTRIES: EUROPE, USA, SOUTH AMERICA, AUSTRALIA and JAPAN"},"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"}