{"doc_desc":{"title":"NATIONAL PROSPECTIVE COHORT ON SARCOMAS\/GIST\/DESMOID AND CONNECTIVE TISSUE TUMOURS","idno":"FRESH-PEF8158-en","producers":[{"name":"Isabelle RAY-COQUARD","affiliation":"CENTRE LEON BERARD"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8158-en","IDno":{"metadata_no":[{"agency":"PEF","code":"8158"},{"agency":"FReSH","code":"FRESH-PEF8158"}]},"title":"NATIONAL PROSPECTIVE COHORT ON SARCOMAS\/GIST\/DESMOID AND CONNECTIVE TISSUE TUMOURS","alternate_title":"NETSARC"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Jean-Yves;BLAY","PILabo":"Centre L\u00e9on B\u00e9rard \/ INSERM U570","affiliationName":"CENTRE LEON BERARD","extlink":[{"title":"ORCID","uri":"0000-0001-7190-120X","role":"pi id"},{"title":"IdRef","uri":"069035407","role":"pi id"},{"title":"SIREN","uri":"779924133","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"jean-yves.blay@lyon.unicancer.fr","isContact":"Yes"},{"type":"investigator","name":"Isabelle;RAY-COQUARD","PILabo":"Centre L\u00e9on B\u00e9rard \/ EAM Sant\u00e9 Individu Soci\u00e9t\u00e9 4129 Universit\u00e9s Lyon 1\/ Lyon 2 \/ Lyon 3","affiliationName":"CENTRE LEON BERARD","extlink":[{"title":"ORCID","uri":"0000-0003-2472-8306","role":"pi id"},{"title":"IdRef","uri":"073702005","role":"pi id"},{"title":"SIREN","uri":"779924133","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"isabelle.ray-coquard@lyon.unicancer.fr","isContact":"Yes"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Jean-Yves;BLAY","email":"jean-yves.blay@lyon.unicancer.fr","type":"contact","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","email":"isabelle.ray-coquard@lyon.unicancer.fr","type":"contact","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":"Sarcoma"},{"keyword":"rare cancers"},{"keyword":"network"},{"keyword":"clinical"},{"keyword":"biological samples"},{"keyword":"ISKS project"},{"keyword":"genetic"},{"keyword":"treatment"}],"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":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"The objectives of this cohort are: real-time integration of patients into a database- to generate real-time national and regional descriptive data for all patients with sarcoma - to provide national indicators of patient care and equal access to care and innovative treatments - to improve knowledge of rare tumours - to investigate the link between sarcomas and genetics.","abstract":"","coll_dates":[{"start":"2010-01-01"}],"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\": \"Infant, Newborn (birth to 28 days)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Infant (28 days to 2 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Child, Preschool (2 to 5 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\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\": \"patients with sarcoma or connective tissue tumours (all ages and histologies) discussed in multidisciplinary meetings (RCP) in regional centres of expertise specialising in the treatment of sarcomas\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data','Paraclinical data (non-biological) : Imaging','Paraclinical data (non-biological) : Other']","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.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[10000-20000[ individuals","response_rate":"17 346:- 11 646 sarcomes\/GIST\/desmoide.- 5 700 tumeurs conjonctives \u00e0 malignit\u00e9 interm\u00e9diaire ou b\u00e9nigne."},"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":"Users can connect with a unique password. Different rights are allocated per profile (clinician, clinical research associate, quality manager, administrator ...). Website terms of use must be previously signed. Non-identifiable patient data (HASH system is being put in place). A scientific committee consisting of representatives clinicians and pathologists centres to large volume of patients in the network is responsible for controlling, analysing and authorising requests for studies from the shared data base.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"Shared database is accessible online and developed by two network I.T. professionals. Data is hosted by a professional hosting provider."}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"24-02-2014","lastUpdatedAuto":null,"lastUpdatedManual":"07-08-2014","isContributorPI":"No","contributorName":"Isabelle RAY-COQUARD","contributorAffiliation":"CENTRE LEON BERARD","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Private non-profit","Private non-profit"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Standardised reports from regional centres specialising in the treatment of sarcomas included in the network.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"The national NETSARC clinical network is composed of 28 regional centres of expertise specialising in sarcoma treatment and research."},"dataTypes":{"clinicalDataDetails":"> Tumor (shared): location, size, depth of invasion > Tumor sample description (from RRePS): case origin, sample type, sample date, diagnosis establish by anatomic pathology structure, by the national reference center, by the coordination site, tumor immunohistochemistry, tumor molecular biology, tumor FISH exam > Main steps of patient management (from NetSarc): tumor type, diagnosis, date of the first diagnosis, stages of cancer, imaging data before resection, biopsy, place and quality of surgery > Multidisciplinary consensus meeting (from NetSarc): date, expert center, timing, decisions > Inclusion in clinical trials (from NetSarc): date, name of clinical trial > Relapse, date of death, date of last follow-up (from NetSarc)","biologicalDataDetails":"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"}