{"doc_desc":{"title":"Cohorte nationale de ressources biologiques d\u00e9di\u00e9e aux complications de l'allogreffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques (CSH)","idno":"FRESH-PEF3107-fr","producers":[{"name":"R\u00e9gis PEFFAULT DE LATOUR","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3107-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3107"},{"agency":"FReSH","code":"FRESH-PEF3107"}]},"title":"Cohorte nationale de ressources biologiques d\u00e9di\u00e9e aux complications de l'allogreffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques (CSH)","alternate_title":"CRYOSTEM"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"},{"name":"CESREES"}]},"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":"Non"},{"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":"Oui"},{"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":"Oui"},{"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":"Non"}],"oth_id":[{"name":"CRYOSTEM est le r\u00e9seau\/consortium national regroupant toutes les unit\u00e9s de greffe fran\u00e7aises adultes et p\u00e9diatriques et 28 centres de ressources biologiques associ\u00e9s, d\u00e9di\u00e9 \u00e0 la compr\u00e9hension et la recherche sur les complications de l'allogreffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques.","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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":"Allogreffe"},{"keyword":"Cellules Souches H\u00e9matopo\u00ef\u00e9tiques"},{"keyword":"Maladie du Greffon contre l'H\u00f4te"},{"keyword":"Unit\u00e9s de greffe"},{"keyword":"CRB"},{"keyword":"Echantillons biologiques"},{"keyword":"Complications"},{"keyword":"Biobanking en R\u00e9seau"}],"topics":[{"topic":"Oncologie","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":"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":"Immunologie m\u00e9dicale","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":"Infectiologie","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":"P\u00e9diatrie","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":"Maladie du greffon contre l'h\u00f4te","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/437372167","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":"L\u2019objectif de CRYOSTEM est de cr\u00e9er une collection nationale, prospective, longitudinale et standardis\u00e9e de pr\u00e9l\u00e8vements biologiques de couples Receveur\/Donneur, adultes et p\u00e9diatriques, pr\u00e9- et post-allogreffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques annot\u00e9es des donn\u00e9es cliniques de patients , dans le but de mettre \u00e0 disposition de la communaut\u00e9 scientifique, acad\u00e9mique et industrielle, nationale et internationale, ces \u00e9chantillons pour des \u00e9tudes de grande envergure sur les complications de l\u2019allogreffe de CSH, dans le but d\u2019en am\u00e9liorer les connaissances ainsi que dans des domaines tels que l\u2019oncologie, l\u2019h\u00e9matologie et l\u2019immunologie. Le but ultime de CRYOSTEM est l\u2019am\u00e9lioration de la prise en charge des patients allogreff\u00e9s gr\u00e2ce \u00e0 une meilleure compr\u00e9hension des complications, le d\u00e9veloppement de tests de diagnostic et de nouvelles th\u00e9rapeutiques.","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":"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\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\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            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients, adultes et p\u00e9diatriques, atteints de maladies s\u00e9v\u00e8res du sang, telles que les cancers du sang (leuc\u00e9mie, lymphome), l'aplasie m\u00e9dullaire ou autres syndromes ...  justifiant l'indication d'une premi\u00e8re allogreffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques dans l'une des unit\u00e9s de greffe participante au projet, ainsi que leurs donneurs apparent\u00e9s ou non-apparent\u00e9s. \",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9l\u00e8vement et envoi \/R\u00e9ception et traitement des pr\u00e9l\u00e8vements \/ Mise \u00e0 disposition']"}},"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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"6 455 patients et 2 482 donneurs au 31 d\u00e9cembre 2021"},"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":"","conditions":"Tout investigateur ayant \u00e9t\u00e9 s\u00e9lectionn\u00e9 par le Comit\u00e9 Scientifique de CRYOSTEM pour acc\u00e9der aux \u00e9chantillons de la collection s'engage \u00e0 respecter les conditions g\u00e9n\u00e9rales de l'appel \u00e0 projets en cours, qui servent de convention de mise \u00e0 disposition. L'investigateur peut avoir acc\u00e8s aux informations d\u00e9mographiques du patient et \u00e0 certaines donn\u00e9es cliniques, extraites du registre europ\u00e9en PROMISe de l'EBMT (European Society for Blood and Marrow Transplantation), fournies sous un fichier anonymis\u00e9 au format Excel. Une fois s\u00e9lectionn\u00e9s, les chefs de projet organisent des entretiens individuels avec les investigateurs pour identifier et s\u00e9lectionner les \u00e9chantillons d'int\u00e9r\u00eat. Les d\u00e9lais de mise \u00e0 disposition sont d\u00e9pendants du nombre d'\u00e9chantillons souhait\u00e9s.","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":"15-02-2012","lastUpdatedAuto":null,"lastUpdatedManual":"16-05-2025","isContributorPI":"Non","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)","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":"Oui"},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Les donn\u00e9es sont recueillies via une fiche de liaison compl\u00e9t\u00e9e lors des pr\u00e9l\u00e8vements sanguins par le personnel en charge du suivi m\u00e9dical du patient.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"type et date de greffe\/rechute et date de rechute\/rejet de greffe\/non prise de greffe\/2\u00e8me allogreffe\/stades et corticor\u00e9sistance si GvHD aigu\u00eb\/nature, classification et \u00e9volution si GvHD chronique","biologicalDataDetails":"Les pr\u00e9l\u00e8vements sanguins des patients et donneurs sont trait\u00e9s et conserv\u00e9s sous forme de 3 types d'\u00e9chantillons (plasma, culots leucocytaires et cellules mononucl\u00e9\u00e9es viables en DMSO.)","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}