{"doc_desc":{"title":"Cohorte de patients atteints de cancer : d\u00e9veloppement et validation d'un score de risque de survenue de thrombose veineuse, \u00e0 partir de param\u00e8tres cliniques et biologiques","idno":"FRESH-PEF150-fr","producers":[{"name":"Christel LECLERC-ZWIRN","affiliation":"GLAXOSMITHKLINE (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF150-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"150"},{"agency":"FReSH","code":"FRESH-PEF150"}]},"title":"Cohorte de patients atteints de cancer : d\u00e9veloppement et validation d'un score de risque de survenue de thrombose veineuse, \u00e0 partir de param\u00e8tres cliniques et biologiques","alternate_title":"CONNEXION CANCER"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Christel;LECLERC-ZWIRN","PILabo":"Laboratoire GSK","affiliationName":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi 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id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"cohorte prospective"},{"keyword":"score de risque"},{"keyword":"oncologie"}],"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":"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":"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":"D\u00e9velopper un score de risque de survenue de thrombose veineuse chez les patients atteints d\u2019un cancer, \u00e0 partir de param\u00e8tres cliniques et biologiques","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2011-01-01"}],"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\": \"\u2022Patient \u00e2g\u00e9 de 18 ans et plus  \u2022Patient pr\u00e9sentant: - Soit un cancer m\u00e9tastatique, quelle que soit sa localisation (\u00e0 l\u2019exception des cancers h\u00e9matopo\u00ef\u00e9tiques), - Soit l\u2019un des cancers suivants, \u00e0 tous les stades de d\u00e9veloppement :  estomac, ovaire, pancr\u00e9as, poumon, vessie, testicule  \u2022Patient : -Dont le cancer est en cours de traitement ou  -Dont le traitement du cancer est pr\u00e9vu ou  -N\u2019ayant pas de traitement anticanc\u00e9reux en cours mais qui a re\u00e7u un traitement (au cours des 3 derni\u00e8res ann\u00e9es) par chimioth\u00e9rapie ou radioth\u00e9rapie ou hormonoth\u00e9rapie ou th\u00e9rapies cibl\u00e9es  \u2022Pour \u00eatre inclus dans l\u2019\u00e9tude, le sujet pour lequel une recherche de param\u00e8tres biologiques suppl\u00e9mentaires sera effectu\u00e9e doit : - avoir donn\u00e9 son consentement libre et \u00e9clair\u00e9 par \u00e9crit, - accepter un pr\u00e9l\u00e8vement sanguin suppl\u00e9mentaire le jour de l\u2019inclusion.\",\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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