{"doc_desc":{"title":"Clinical biological database of the Sarcoma network","idno":"FRESH-PEF73354-en","producers":[{"name":"St\u00e9phanie HOPPE","affiliation":"UNICANCER GROUP"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73354-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73354"},{"agency":"FReSH","code":"FRESH-PEF73354"}]},"title":"Clinical biological database of the Sarcoma network","alternate_title":"BCB sarcomes"},"study_authorization":{"agency":[]},"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":"Yes"},{"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":"Yes"}],"oth_id":[{"name":"","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"sarcomas"},{"keyword":"networks"},{"keyword":"expertise"},{"keyword":"epidemiological and clinical research"}],"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":"Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic, central nervous system or related tissues","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1643222460","title":"CIM-11"}]}],"purpose":"The objective of the programme is to improve quality in the collection of samples and data, the design of new modules and tools, and improve interoperability to improve epidemiological, clinical, fundamental and translational research and medical practices in these pathologies. Three areas of work have been defined: - WP1: data collection and data management - WP2: development of the clinico-biological sarcoma database - WP3: communication.","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 soft tissue and visceral sarcomas included in one of the existing databases: RRePS\\\/NetSarc, Conticabase and ConticaGist\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data','Socio-demographic data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Database training for the different users. There is a quality procedure guide (control of duplicates, cases to be deleted, missing data, cases to be reviewed in third reading, consistency control between variables). External audits of the centres are carried out for the quality of the data']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nOthers"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":""}},"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":">= 20000 individuals","response_rate":"Conticabase and conticaGist contain data from approximately 13,000 patients and the RRePS database contains data from approximately 8,500 patients"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Morbidity registry"]}]},"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":"There are: 1\/ A charter for the use of the websites and the shared database of the sarcoma RRePS and NetSarc reference networks 2\/ A charter for 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":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"03-08-2016","lastUpdatedAuto":null,"lastUpdatedManual":"23-10-2017","isContributorPI":"No","contributorName":"Simone MATHOULIN-PELISSIER","contributorAffiliation":"INSTITUT BERGONIE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"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":"The data is collected by clinical researchers with dedicated time and via consultation meetings","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"The RRePS and NetSarc networks are each coordinated by three sites: Bergoni\u00e9 Cancer Institute in Bordeaux, the Centre L\u00e9on B\u00e9rard in Lyon and Institut Gustave Roussy in Villejuif and work in conjunction with regional expert centres throughout the country."},"dataTypes":{"clinicalDataDetails":"Medical history, location and depth of the tumour, Data contained in the Multidisciplinary Consultation Meeting or in the patient's medical record: type of tumour, diagnosis and date, metastasis, imaging before surgery, initial biopsy, grade, date and establishment of surgery, quality of exeresis, local\/metastatic recurrence, date of latest news, vital status, patient participation in a clinical trial, data on the sample (sampling date, reception, diagnosis, techniques used and stored material)","biologicalDataDetails":"data on the characteristics of the tumour","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}