{"doc_desc":{"title":"Constitution d'une base de donn\u00e9es nationale fran\u00e7aise des cancers dermatologiques rares : Cohorte Carcinomes de Merkel","idno":"FRESH-PEF73397-fr","producers":[{"name":"Beno\u00eet MINART","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73397-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73397"},{"agency":"FReSH","code":"FRESH-PEF73397"}]},"title":"Constitution d'une base de donn\u00e9es nationale fran\u00e7aise des cancers dermatologiques rares : Cohorte Carcinomes de Merkel","alternate_title":"CARADERM"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"authoring_entity":[{"type":"investigator","name":"Laurent;MORTIER","PILabo":"CHRU de Lille","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","extlink":[{"title":"ORCID","uri":"0000-0002-2644-1790","role":"pi id"},{"title":"IdRef","uri":"073412295","role":"pi id"},{"title":"SIREN","uri":"265906719","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"laurent.mortier@chru-lille.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02ppyfa04","role":"sponsor id"},{"title":"SIREN","uri":"265906719","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Astrid;BLOM","email":"astrid.blom@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Philippe;SAIAG","email":"philippe.saiag@uvsq.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Laurent;MORTIER","email":"laurent.mortier@chru-lille.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02ppyfa04","role":"organisation id","title":"ROR"},{"uri":"265906719","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Carcinome de Merkel"},{"keyword":"recherche fondamentale et translationnelle"},{"keyword":"r\u00e9seau"},{"keyword":"cohorte"},{"keyword":"\u00e9pid\u00e9miologie"},{"keyword":"phases pr\u00e9-cliniques aux phases III"},{"keyword":"instances nationales"},{"keyword":"europ\u00e9ennes et internationales"}],"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":"Dermatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5375c411-6db9-40ed-a854-6554102a587b"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D003880"}]},{"topic":"Tumeurs","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]}],"purpose":"Objectif principal Constitution d\u2019une base de donn\u00e9es clinico-histologique pour les carcinomes de Merkel. Objectifs secondaires 1. Fournir un tableau de bord annuel du suivi clinique des patients permettant \u00e0 partir de cette cohorte de : - r\u00e9aliser des analyses descriptives \u00e9pid\u00e9miologiques et des \u00e9tudes de corr\u00e9lation sur l\u2019ensemble du territoire national. - identifier et valider de nouveaux facteurs pronostiques cliniques, - \u00e9valuer le b\u00e9n\u00e9fice risque des traitements autoris\u00e9s et en cours d\u2019autorisation des cancers cutan\u00e9s rares. 2. Assurer des discussions de prise en charge RCP (r\u00e9union de concertation pluridisciplinaire) pour tous les patients porteurs d\u2019un de ces cancers rares sur le territoire national dans le cadre d\u2019une des RCP r\u00e9gionales. Si n\u00e9cessaire, organiser une RCP Nationale de recours 4. Elaborer et actualiser des recommandations de bonnes pratiques cliniques nationales. 5. Structurer la recherche clinique et fondamentale sur les cancers cutan\u00e9s rares, en favorisant l\u2019inclusion des patients atteints de cancers cutan\u00e9s rares dans des essais th\u00e9rapeutiques de nouveaux m\u00e9dicaments. 6. Organiser la formation des soignants (m\u00e9dical et param\u00e9dical) et l\u2019information des patients a\u0300 l\u2019\u00e9chelon r\u00e9gional ou interr\u00e9gional.","abstract":"","coll_dates":[{"start":"2014-01-01","end":"2018-01-01"}],"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\": \"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\": \"Crit\u00e8res d\u2019inclusion : -Patients adultes atteints de cancers cutan\u00e9s rares confirm\u00e9s histologiquement : Carcinome de Merkel -Patients volontaires pour participer \u00e0 l\u2019\u00e9tude. -Age \u2265 18 ans. -Patients ne s\u2019opposant pas \u00e0 la r\u00e9utilisation \u00e0 des fins scientifiques de leurs donn\u00e9es. \",\n    \"clusion_E\": \"Refus du patient -Patient sous tutelle ou curatelle -Age < 18 ans\"\n}","data_kind":"['Donn\u00e9es 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