{"doc_desc":{"title":"Cryoconservation during allogeneic hematopoietic Stem cell transplantation","idno":"FRESH-PEF3107-en","producers":[{"name":"R\u00e9gis PEFFAULT DE LATOUR","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3107-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3107"},{"agency":"FReSH","code":"FRESH-PEF3107"}]},"title":"Cryoconservation during allogeneic hematopoietic Stem cell transplantation","alternate_title":"CRYOSTEM"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"R\u00e9gis;PEFFAULT DE LATOUR","PILabo":"H\u00f4pital Saint Louis, Paris (AP-HP) \/ Service d'h\u00e9matologie \/ Greffe Plot B Tr\u00e8fle 3","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0001-6222-4753","role":"pi id"},{"title":"IdRef","uri":"092887112","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Julie;AGOPIAN","PILabo":"Association CRYOSTEM \/ Association CRYOSTEM","affiliationName":"ASSOCIATION CRYOSTEM","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"813575081","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"julie.agopian@cryostem.org","isContact":"Yes"},{"type":"investigator","name":"Emilie;ROBERT","PILabo":"Association CRYOSTEM \/ Association CRYOSTEM","affiliationName":"ASSOCIATION CRYOSTEM","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"813575081","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"emilie.robert@cryostem.org","isContact":"Yes"},{"type":"investigator","name":"Boris;CALMELS","PILabo":"Institut Paoli Calmettes, Marseille \/ Centre de th\u00e9rapie cellulaire","affiliationName":"INSTITUT JEAN PAOLI & IRENE CALMETTES CENTRE REGIONAL DE LUTTE CONTRE LE CANCER","extlink":[{"title":"ORCID","uri":"0000-0002-1684-6030","role":"pi id"},{"title":"IdRef","uri":"070354545","role":"pi id"},{"title":"SIREN","uri":"782921233","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"}],"oth_id":[{"name":"CRYOSTEM is the national network\/consortium bringing together all French adult and pediatric transplant units and 28 associated biological resource centers, dedicated to understanding and researching the complications of allogeneic hematopoietic stem cell transplantation.","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"ASSOCIATION CRYOSTEM","extlink":[{"title":"SIREN","uri":"813575081","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Julie;AGOPIAN","email":"julie.agopian@cryostem.org","type":"contact","affiliationName":"ASSOCIATION CRYOSTEM","contactPointLabo":"","extlink":[{"uri":"813575081","role":"organisation id","title":"SIREN"}]},{"name":"Emilie;ROBERT","email":"emilie.robert@cryostem.org","type":"contact","affiliationName":"ASSOCIATION CRYOSTEM","contactPointLabo":"","extlink":[{"uri":"813575081","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Graft-versus-host-disease"},{"keyword":"GvHD"},{"keyword":"Allogeneic Hematopoietic Stem Cell Transplantation"},{"keyword":"HSCT"},{"keyword":"Biobanking network"},{"keyword":"Complications"}],"topics":[{"topic":"Oncology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D008495"}]},{"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":"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":"Infectious disease medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"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":"Graft-versus-host disease","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/437372167","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"The goal of CryoStem is to create a national, multicenter, prospectie, longitudinal, standardized HSCT human-sample collection (derived from adult and pediatric patients) with the purpose of enabling better characterization and prediction of HSCT complications occurence and outcome, including GvHD. CryoStem has generated a French network involving all the French transplant units, adult and pediatric and 28 Biological Resources Centres. Only in a network such as this may the full potential be realized of having concrete and effective interactions between scientists with top knowledge in specific areas and physicians. CryoStem fosters interactions among internationally recognized experts in advanced biotechnology (genomics,transcriptomics, proteomics, and flow cytometry). Altogether, CryoStem provides a structured approach for a range of different research activities, bringing together leading-edge researchers who can access documented biological (CryoStem) and clinical (ProMISe) samples from transplanted patients in order to better characterize and predict HSCT complications.","abstract":"","coll_dates":[{"start":"2012-01-01","end":"2021-01-01"}],"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            \"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            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Any patient suffering from  a severe blood disease or blood cancer (leukemia, lymphoma, aplastic anemia...) justifying a first HSCT in one of the transplant units of CRYOSTEM network.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Sampling and sending \/ blood samples reception and processing \/ provision']"}},"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":"[1000-10000[ individuals","response_rate":"6 455 patients and 2 482 donors as of December 2021, 31"},"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":"","conditions":"Any investigator selected by CRYOSTEM Scientific Committee commits himself to respect the general terms of the current call of projects to access the collection biological resources. The investigator could access to demographical and clinical information, extracted from the European register of the EBMT (European Society for Blood and Marrow Transplantation), provided via an Excel file made anonymous. Once selected, CRYOSTEM project managers schedule interviews with the investigators in order to identify and select the samples of interest. The delay of provision depend on the number of the samples waited for.","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":"15-02-2012","lastUpdatedAuto":null,"lastUpdatedManual":"16-05-2025","isContributorPI":"No","contributorName":"R\u00e9gis PEFFAULT DE LATOUR","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Metabolomics analysis of human acute graft-versus-host disease reveals changes in host and microbiota-derived metabolites","link":"https:\/\/doi.org\/10.1038\/s41467-019-13498-3"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Private non-profit"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":"Yes"},"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":"Data are collected via a unique document filled in as the time of blood samples by the transplant units staff in charge of the patient medical follow-up.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Metropolitan France"},"dataTypes":{"clinicalDataDetails":"transplant type and date \/ relapse \/ graft failure \/ second transplant \/ stages and corticoresistance for the acute GvHD \/ type, classification and evolution of the chronic GvHD","biologicalDataDetails":"Blood samples","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}