{"doc_desc":{"title":"Cohorte de patients pr\u00e9sentant une tumeur cartilagineuse unique non op\u00e9r\u00e9e - incidence des chondrosarcomes dans la population des chondromes solitaires","idno":"FRESH-PEF8130-fr","producers":[{"name":"Fran\u00e7ois GOUIN","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8130-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8130"},{"agency":"FReSH","code":"FRESH-PEF8130"}]},"title":"Cohorte de patients pr\u00e9sentant une tumeur cartilagineuse unique non op\u00e9r\u00e9e - incidence des chondrosarcomes dans la population des chondromes solitaires","alternate_title":"CHONSOL"},"study_authorization":{"agency":[{"name":"CNIL"}]},"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":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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":"Chondrome solitaire"},{"keyword":"chondrosarcome"},{"keyword":"marqueurs mol\u00e9culaires"},{"keyword":"domicile"},{"keyword":"RESOS"},{"keyword":"facteurs pronostiques de survenue."}],"topics":[{"topic":"Orthop\u00e9die et traumatologie","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":"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":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"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":"L\u2019objectif principal de l\u2019\u00e9tude sera de pouvoir d\u00e9terminer quelle est \u00e0 5 ans, l\u2019incidence de chondrosarcome dans la population des chondromes solitaires. Les objectifs secondaires de l\u2019\u00e9tude seront: -D\u00e9terminer quelle est \u00e0 10 ans, l\u2019incidence de chondrosarcome dans la population des chondromes solitaires -D\u00e9crire les modalit\u00e9s de diagnostic et de suivi des chondromes solitaires -D\u00e9crire les indications \u00e0 une biopsie, un curetage ou \u00e0 une r\u00e9section -D\u00e9crire les niveaux de qualit\u00e9 de vie globale et de douleur des patients atteints d\u2019un chondrome solitaire ainsi que l\u2019impact d\u2019une biopsie, d\u2019un curetage ou d\u2019une r\u00e9section sur ces derniers -D\u00e9crire les facteurs d\u00e9mographiques, cliniques, radiologiques, biologiques, mol\u00e9culaires et g\u00e9n\u00e9tiques associ\u00e9s \u00e0, ou pr\u00e9dictif de la survenue d\u2019une \u00e9volution sarcomateuse. -D\u00e9crire les facteurs d\u00e9mographiques, cliniques, radiologiques, biologiques, mol\u00e9culaires et g\u00e9n\u00e9tiques pr\u00e9dictifs d\u2019une \u00e9volution (alt\u00e9ration ou am\u00e9lioration) de la qualit\u00e9 de la vie globale et du niveau de douleur chez les patients atteints d\u2019un chondrome solitaire -Evaluer les risques iatrog\u00e8nes de la biopsie, du curetage ou de la r\u00e9section de ces chondromes solitaires","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":"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            \"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\": \"Les crit\u00e8res d\u2019inclusion seront les suivants : -Patients \u00e2g\u00e9s de plus de 18 ans -Patients pr\u00e9sentant une tumeur cartilagineuse unique non op\u00e9r\u00e9e -Patients avec des crit\u00e8res radiologiques et scintigraphique et TDM et\\\/ou IRM de chondrome solitaire -Patients ayant accept\u00e9 de participer \u00e0 l\u2019\u00e9tude et au suivi propos\u00e9, et ayant sign\u00e9 le formulaire de consentement \u00e9clair\u00e9 pour la biocollection.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","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\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"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) Base m\u00e9dico-administrative (de patients, Assurance Maladie\/Mutuelle) Registre de maladies, de d\u00e9c\u00e8s']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"200"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"20-02-2014","lastUpdatedAuto":null,"lastUpdatedManual":"19-08-2014","isContributorPI":"Non","contributorName":"Fran\u00e7ois GOUIN","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public 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ADN","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}