{"doc_desc":{"title":"Base clinico biologique du r\u00e9seau Sarcomes","idno":"FRESH-PEF73354-fr","producers":[{"name":"St\u00e9phanie HOPPE","affiliation":"UNICANCER GROUP"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73354-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73354"},{"agency":"FReSH","code":"FRESH-PEF73354"}]},"title":"Base clinico biologique du r\u00e9seau Sarcomes","alternate_title":"BCB sarcomes"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Simone;MATHOULIN-PELISSIER","PILabo":"Institut Bergoni\u00e9 \/ Clinical Research and Epidemiology Unit and CIC1401","affiliationName":"INSTITUT BERGONIE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"071358587","role":"pi id"},{"title":"SIREN","uri":"781831714","role":"organisation id"},{"title":"RNSR","uri":"200120110J","role":"labo id"}],"email":"simone.pelissier@u-bordeaux.fr","isContact":"Oui"},{"type":"investigator","name":"Jean-Michel;COINDRE","PILabo":"Institut Bergoni\u00e9 \/ Department of Pathology","affiliationName":"INSTITUT BERGONIE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"059858478","role":"pi id"},{"title":"SIREN","uri":"781831714","role":"organisation id"},{"title":"RNSR","uri":"200120110J","role":"labo id"}],"email":"J.Coindre@bordeaux.unicancer.fr","isContact":"Oui"}],"oth_id":[{"name":"R\u00e9seaux nationaux RRePS et NetSarc et r\u00e9seau europ\u00e9en Conticanet","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT BERGONIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02yw1f353","role":"sponsor id"},{"title":"SIREN","uri":"781831714","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]}]},"distribution_statement":{"contact":[{"name":"Simone;MATHOULIN-PELISSIER","email":"simone.pelissier@u-bordeaux.fr","type":"contact","affiliationName":"INSTITUT BERGONIE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02yw1f353","role":"organisation id","title":"ROR"},{"uri":"781831714","role":"organisation id","title":"SIREN"}]},{"name":"Jean-Michel;COINDRE","email":"J.Coindre@bordeaux.unicancer.fr","type":"contact","affiliationName":"INSTITUT BERGONIE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02yw1f353","role":"organisation id","title":"ROR"},{"uri":"781831714","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"sarcomes"},{"keyword":"r\u00e9seaux"},{"keyword":"expertises"},{"keyword":"recherche \u00e9pid\u00e9miologiques et cliniques"}],"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":"Tumeurs malignes, d\u00e9clar\u00e9es ou suppos\u00e9es primitives, de localisations pr\u00e9cis\u00e9es, \u00e0 l'exception des tissus lympho\u00efde, h\u00e9matopo\u00ef\u00e9tique, du syst\u00e8me nerveux central ou de tissus apparent\u00e9s","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1643222460","title":"CIM-11"}]},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"},{"topic":"Autre","vocab":"health determinant"}],"purpose":"L'objectif du programme est d'am\u00e9liorer la qualit\u00e9 concernant la collecte des \u00e9chantillons et des donn\u00e9es, la conception de nouveaux modules et outils, et d'am\u00e9liorer l'interop\u00e9rabilit\u00e9 afin d'am\u00e9liorer la recherche \u00e9pid\u00e9miologique, clinique, fondamentale et translationnelle et les pratiques m\u00e9dicales dans ces pathologies. Trois axes de travail ont \u00e9t\u00e9 d\u00e9finis : - WP1 : collection des donn\u00e9es et data management - WP2 : d\u00e9veloppement de la base clinico biologique sarcomes - WP3 : communication.","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 d'un sarcomes des tissus mous ou des visc\u00e8res inclus dans une des bases de donn\u00e9es existantes : RRePS\\\/NetSarc, Conticabase et Conticagist\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Formations \u00e0 la base de donn\u00e9es pour les diff\u00e9rents utilisateurs. Il existe un livret de proc\u00e9dures qualit\u00e9 (contr\u00f4le des doublons, cas \u00e0 supprimer, donn\u00e9es manquantes, cas \u00e0 revoir en 3\u00e8me lecture, contr\u00f4le de coh\u00e9rence entre variables. Des audits externes des centres sont r\u00e9alis\u00e9s pour la qualit\u00e9 des donn\u00e9es']"}},"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\nAutres"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":""}},"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":">= 20000 individus","response_rate":"Conticabase et conticagist contiennent les donn\u00e9es d'environ 13000 patients et la base de donn\u00e9es RRePS contient les donn\u00e9es d'environ 8500 patients"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Registre de morbidit\u00e9"]}]},"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":"Il existe : 1\/ 1 charte d'utilisation des sites internet et de la base partag\u00e9e des r\u00e9seaux de r\u00e9f\u00e9rence sarcome RRePS et NetSarc 2\/ 1 charte pour conticanet : 'Definition of rules for access and use of data and materiel among CTCN partners'","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":"03-08-2016","lastUpdatedAuto":null,"lastUpdatedManual":"23-10-2017","isContributorPI":"Non","contributorName":"Simone MATHOULIN-PELISSIER","contributorAffiliation":"INSTITUT BERGONIE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Les donn\u00e9es sont collect\u00e9es par des attach\u00e9s de recherche clinique avec des temps d\u00e9di\u00e9es et via les r\u00e9unions de concertations","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Les R\u00e9seaux RRePS et NetSarc sont chacun coordonn\u00e9s par 3 sites : Institut bergoni\u00e9 \u00e0 Bordeaux, le centre L\u00e9on B\u00e9rard \u00e0 Lyon et l'Institut Gustave Roussy \u00e0 Villejuif et travaillent en lien avec les centres experts r\u00e9gionaux r\u00e9partis sur tout le territoire national."},"dataTypes":{"clinicalDataDetails":"Ant\u00e9c\u00e9dents, localisation et profondeur de la tumeur, Donn\u00e9es contenues dans la fiche de R\u00e9union de Concertation Pluridisciplinnaire ou dans le dossier m\u00e9dical du patient : type de tumeur, diagnostic et date, m\u00e9tastases, imagerie avant chirurgie,biopsie initiale, grade, date et \u00e9tablissement de la chirurgie, qualit\u00e9 d'exer\u00e8se, r\u00e9cidive locale\/m\u00e9tastatique, date des derni\u00e8res nouvelles, statut vital., participation du patient a un essai clinique, donn\u00e9es concernant le pr\u00e9l\u00e8vement (date pr\u00e9l\u00e8vement, r\u00e9ception, diagnostic, techniques utilis\u00e9es et mat\u00e9riel stock\u00e9)","biologicalDataDetails":"donn\u00e9es sur les caract\u00e9ristiques de la tumeur","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}