{"doc_desc":{"title":"Creation of a French national database of rare dermatological cancers: Inoperable or metastatic Basal Cell Carcinoma Cohort","idno":"FRESH-PEF73395-en","producers":[{"name":"Beno\u00eet MINART","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73395-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73395"},{"agency":"FReSH","code":"FRESH-PEF73395"}]},"title":"Creation of a French national database of rare dermatological cancers: Inoperable or metastatic Basal Cell Carcinoma Cohort","alternate_title":"CARADERM"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Bernard;GUILLOT","PILabo":"CHU Montpellier","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER (CHU)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"034280936","role":"pi id"},{"title":"SIREN","uri":"263400160","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"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":"basic and translational research"},{"keyword":"network"},{"keyword":"cohort"},{"keyword":"epidemiology"},{"keyword":"pre-clinical to phase III"},{"keyword":"national, European and international bodies"},{"keyword":"Basal Cell Carcinoma"}],"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":"Dermatology","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":"Neoplasms","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]}],"purpose":"Main objective Creation of a clinical-histological database for inoperable or metastatic forms of basal cell carcinoma.. Secondary objectives 1. to provide an annual dashboard of patients' clinical follow-up, enabling this cohort to: - carry out descriptive epidemiological analyses and correlation studies throughout France - identify and validate new clinical prognostic factors, - evaluate the benefit-risk of authorized and pending treatments for rare skin cancers 2. ensure RCP (multidisciplinary consultation meeting) management discussions for all patients with one of these rare cancers nationwide, within the framework of one of the regional RCPs. If necessary, organize a national referral RCP 4. draw up and update national recommendations for good clinical practice 5. structure clinical and fundamental research into rare cutaneous cancers, by encouraging the inclusion of patients with rare cutaneous cancers in therapeutic trials for new drugs 6. organize training for caregivers (medical and paramedical) and patient information at regional or inter-regional level..","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":"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\": \"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               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schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}"],"research_instrument":"","sources":[],"target_sample_size":"","response_rate":"199"},"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\":\"Metadata-only access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_14cb\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal 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