{"doc_desc":{"title":"Etude longitudinale sur des patients atteints de sarcome ou tumeur conjonctive","idno":"FRESH-PEF8158-fr","producers":[{"name":"Isabelle RAY-COQUARD","affiliation":"CENTRE LEON BERARD"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8158-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8158"},{"agency":"FReSH","code":"FRESH-PEF8158"}]},"title":"Etude longitudinale sur des patients atteints de sarcome ou tumeur conjonctive","alternate_title":"NETSARC"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"authoring_entity":[{"name":"Jean-Yves;BLAY","firstname":"Jean-Yves","lastname":"BLAY","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01cmnjq37","role":"organisation id"},{"title":"SIREN","uri":"779924133","role":"organisation id"}],"email":"jean-yves.blay@lyon.unicancer.fr","affiliationName":"CENTRE LEON BERARD","PILabo":"Centre L\u00e9on B\u00e9rard \/ INSERM U570","isContact":true},{"name":"Isabelle;RAY-COQUARD","firstname":"Isabelle","lastname":"RAY-COQUARD","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01cmnjq37","role":"organisation id"},{"title":"SIREN","uri":"779924133","role":"organisation id"}],"email":"isabelle.ray-coquard@lyon.unicancer.fr","affiliationName":"CENTRE LEON BERARD","PILabo":"Centre L\u00e9on B\u00e9rard \/ EAM Sant\u00e9 Individu Soci\u00e9t\u00e9 4129 Universit\u00e9s Lyon 1\/ Lyon 2 \/ Lyon 3","isContact":true}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE LEON BERARD","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01cmnjq37","role":"sponsor id"},{"title":"SIREN","uri":"779924133","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"INFO SARCOMES","extlink":[{"title":"SIREN","uri":"530748169"}]},{"name":""}]},"distribution_statement":{"contact":[{"name":"Jean-Yves;BLAY","lastname":"BLAY","firstname":"Jean-Yves","type":"contact","email":"jean-yves.blay@lyon.unicancer.fr","affiliationName":"CENTRE LEON BERARD","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01cmnjq37","role":"organisation id","title":"ROR"},{"uri":"779924133","role":"organisation id","title":"SIREN"}]},{"name":"Isabelle;RAY-COQUARD","lastname":"RAY-COQUARD","firstname":"Isabelle","type":"contact","email":"isabelle.ray-coquard@lyon.unicancer.fr","affiliationName":"CENTRE LEON BERARD","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01cmnjq37","role":"organisation id","title":"ROR"},{"uri":"779924133","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Sarcome"},{"keyword":"r\u00e9seau"},{"keyword":"clinique"},{"keyword":"pr\u00e9l\u00e8vements biologiques"},{"keyword":"projet ISKS"},{"keyword":"cancers rares"},{"keyword":"prise en charge"},{"keyword":"g\u00e9n\u00e9tique"}],"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":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Les objectifs de cette cohorte sont : - d\u2019int\u00e9grer les patients en temps r\u00e9el dans la base de donn\u00e9es - de produire en temps r\u00e9el des donn\u00e9es descriptives nationales ou r\u00e9gionales concernant tous les patients atteints de sarcome - de disposer d\u2019indicateurs nationaux de prise en charge des patients et d\u2019\u00e9quit\u00e9 d\u2019acc\u00e8s aux soins et traitements innovants - d\u2019initier\/coordonner des \u00e9tudes \u00e9pid\u00e9miologiques et des recherches translationnelles - d\u2019am\u00e9liorer les connaissances sur ces tumeurs rares - mettre en \u00e9vidence le lien entre g\u00e9n\u00e9tique et sarcomes","abstract":"","coll_dates":[{"start":"2010-01-01"}],"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\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\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\": \" patients atteints de sarcome ou tumeur conjonctive (tout \u00e2ge, toutes histologies) discut\u00e9s dans les r\u00e9unions pluridisciplinaires (RCP) des centres r\u00e9gionaux experts dans la prise en charge des sarcomes\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie','Donn\u00e9es paracliniques (hors biologiques) : Autre']","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)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[10000-20000[ individus","response_rate":"17 346:- 11 646 sarcomes\/GIST\/desmoide.- 5 700 tumeurs conjonctives \u00e0 malignit\u00e9 interm\u00e9diaire ou b\u00e9nigne."},"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":"Les utilisateurs se connectent via un mot de passe unique. Des droits diff\u00e9rents leur sont donn\u00e9s en fonction de leur profil (clinicien, attach\u00e9 de recherche clinique, responsable qualit\u00e9, administrateur,\u2026). Ils doivent avoir au pr\u00e9alable sign\u00e9e une charte d\u2019utilisation du site. Les donn\u00e9es des patients sont non identifiantes (un syst\u00e8me de HASH est en cours de mise en place). Un comit\u00e9 scientifique constitu\u00e9 par des repr\u00e9sentants cliniciens et pathologistes des centres \u00e0 gros volume de patients du r\u00e9seau est charg\u00e9 de r\u00e9guler, analyser et autoriser les demandes d\u2019\u00e9tudes \u00e0 partir des donn\u00e9es de la base partag\u00e9e.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"La base de donn\u00e9es partag\u00e9e accessible via internet a \u00e9t\u00e9 d\u00e9velopp\u00e9e par deux informaticiens du r\u00e9seau. Les donn\u00e9es sont h\u00e9berg\u00e9es chez un h\u00e9bergeur professionnel."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"24-02-2014","lastUpdatedAuto":null,"lastUpdatedManual":"07-08-2014","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Comptes-rendus standardis\u00e9s des centres sp\u00e9cialis\u00e9s dans la prise en charge des sarcomes du r\u00e9seau .","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Le r\u00e9seau clinique national NETSARC est constitu\u00e9 de 28 centres experts r\u00e9gionaux, sp\u00e9cialis\u00e9s dans la prise en charge et la recherche portant sur les sarcomes"},"dataTypes":{"clinicalDataDetails":"> Tumeur (partag\u00e9): localisation, taille, profondeur de l'invasion. > Principales \u00e9tapes de la gestion des patients : type de tumeur, le diagnostic, la date du premier diagnostic, les stades du cancer, le lieu et la qualit\u00e9 de la chirurgie > R\u00e9union multidisciplinaire de consensus : date, centre d'expertise, le calendrier, les d\u00e9cisions > L'inclusion dans les essais cliniques : date, nom de l'essai clinique > Relapse, date du d\u00e9c\u00e8s, la date du dernier suivi","biologicalDataDetails":"ADN. > Description de l'\u00e9chantillon de la tumeur (de RRePS): l'origine, le type d'\u00e9chantillon, la date de l'\u00e9chantillon, le diagnostic \u00e9tabli par la structure de pathologie anatomique, par le centre national de r\u00e9f\u00e9rence, par le site de coordination, immunohistochimie de la tumeur, FISH tumorale examen","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}