{"doc_desc":{"title":"CHONSOL","idno":"FRESH-PEF8130-en","producers":[{"name":"Fran\u00e7ois GOUIN","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8130-en","IDno":{"metadata_no":[{"agency":"PEF","code":"8130"},{"agency":"FReSH","code":"FRESH-PEF8130"}]},"title":"CHONSOL","alternate_title":""},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Fran\u00e7ois;GOUIN","PILabo":"CHU \/ Service de chirurgie orthop\u00e9dique et traumatologique du CHU Nantes","affiliationName":"chu","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"068934629","role":"pi id"},{"title":"SIREN","uri":"264400136","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"Francois.GOUIN@lyon.unicancer.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05c1qsg97","role":"sponsor id"},{"title":"SIREN","uri":"264400136","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Fran\u00e7ois;GOUIN","email":"Francois.GOUIN@lyon.unicancer.fr","type":"contact","affiliationName":"chu","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05c1qsg97","role":"organisation id","title":"ROR"},{"uri":"264400136","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Solitary chondroma"},{"keyword":"chondrosarcoma"},{"keyword":"molecular markers"},{"keyword":"home"},{"keyword":"prognostic factors of onset."},{"keyword":"RESOS"}],"topics":[{"topic":"Orthopaedics and traumatology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4538836-ae58-4941-b544-50f53e979e20"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009985"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D014194"}]},{"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":"Behavioral determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"The main objective of the study is to determine the incidence of chondrosarcoma at 5 years in a population presenting with solitary chondroma. The secondary objectives of the study are: - To determine the incidence of chondrosarcoma at 10 years a population presenting with solitary chondroma -To describe solitary chondroma diagnosis and follow-up modalities - To describe indications for biopsy, curettage or resection - To describe the level of pain and overall quality of life for patients with solitary chondroma as well as the impact of biopsy, curettage or resection -To describe the demographic, clinical, radiological, biological, molecular and genetic factors associated with, or predictive of, sarcomatous change. - To describe the demographic, clinical, radiological, biological, molecular and genetic factors predicting change (improvement or deterioration) in the overall quality of life and level of pain in patients with solitary chondroma - To evaluate the iatrogenic risks of biopsy, curettage or resection of solitary chondroma","abstract":"","coll_dates":[{"start":"2015-01-01","end":"2030-01-01"}],"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                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Inclusion criteria are: -Patients over 18 years of age -Patients with a single cartilaginous non-operative tumour -Patients fulfilling radiographic, scintigraphic, CT and\\\/or MRI criteria for solitary chondroma -Patients who agreed to participate in the study and proposed follow-up and who have signed the informed consent for biocollection.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.) Medical-administrative database (patients, health insurance\/mutual insurance) Disease and death registry']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"200"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"20-02-2014","lastUpdatedAuto":null,"lastUpdatedManual":"19-08-2014","isContributorPI":"No","contributorName":"Fran\u00e7ois GOUIN","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE 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DNA","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}