{"doc_desc":{"title":"Etude longitudinale sur des patients n\u2019ayant pas rechut\u00e9 apr\u00e8s arr\u00eat de traitement par inhibiteurs de tyrosine kinase pour leuc\u00e9mie my\u00e9lo\u00efde chronique","idno":"FRESH-PEF5419-fr","producers":[{"name":"Fran\u00e7ois-Xavier MAHON","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5419-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5419"},{"agency":"FReSH","code":"FRESH-PEF5419"}]},"title":"Etude longitudinale sur des patients n\u2019ayant pas rechut\u00e9 apr\u00e8s arr\u00eat de traitement par inhibiteurs de tyrosine kinase pour leuc\u00e9mie my\u00e9lo\u00efde chronique","alternate_title":"Les STIMs"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Fran\u00e7ois-Xavier;MAHON","firstname":"Fran\u00e7ois-Xavier","lastname":"MAHON","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"organisation id"},{"title":"SIREN","uri":"130018351","role":"organisation id"}],"email":"Francois-Xavier.Mahon@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","PILabo":"Universit\u00e9 Bordeaux \/ H\u00e9matopo\u00ef\u00e8se Leuc\u00e9mique et Cible th\u00e9rapeutiques","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"sponsor id"},{"title":"SIREN","uri":"130018351","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"}]}]},"distribution_statement":{"contact":[{"name":"Fran\u00e7ois-Xavier;MAHON","lastname":"MAHON","firstname":"Fran\u00e7ois-Xavier","type":"contact","email":"Francois-Xavier.Mahon@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"inhibiteur de tyrosine kinase"},{"keyword":"arr\u00eat traitement"},{"keyword":"r\u00e9ponse mol\u00e9culaire compl\u00e8te"},{"keyword":"rechute."}],"topics":[{"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":"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":"Suivre les patients pour lesquels les inhibiteurs de la thymidine kinase ont \u00e9t\u00e9 arr\u00eat\u00e9s depuis au moins deux ans afin de connaitre leur statut mol\u00e9culaire et colliger les \u00e9ventuelles rechutes mol\u00e9culaires tardives.","abstract":"","coll_dates":[{"start":"2010-01-01"}],"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\": \"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Homme ou femme \u00e2g\u00e9 d\u2019au moins 18 ans Leuc\u00e9mie my\u00e9lo\u00efde chronique en phase chronique ou acc\u00e9l\u00e9r\u00e9e trait\u00e9e par imatinib depuis au moins 3 ans R\u00e9mission mol\u00e9culaire compl\u00e8te depuis au moins 2 ans sous imatinib Pour les femmes en \u00e2ge de procr\u00e9er n\u00e9cessit\u00e9 d'avoir recours \u00e0 une m\u00e9thode de contraception fiable  Sujets affili\u00e9s ou b\u00e9n\u00e9ficiaire d\u2019un r\u00e9gime de s\u00e9curit\u00e9 sociale S\u00e9rologie VIH n\u00e9gative et absence d\u2019h\u00e9patite B ou C chronique Consentement libre, \u00e9clair\u00e9 et expr\u00e8s donn\u00e9 par \u00e9crit Suivi mol\u00e9culaire selon les recommandations du \u00ab LeukemiaNet \u00bb Europ\u00e9en\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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\r\nConsommation de soins\/services de sant\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 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