{"doc_desc":{"title":"Incidence study with population of Rhone-Alpes region of cancers eligible for hadrontherapy by proton or carbon ions. Description of Tumors and patients characteristics","idno":"FRESH-PEF2995-en","producers":[{"name":"Pascal POMMIER","affiliation":"CENTRE LEON BERARD"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF2995-en","IDno":{"metadata_no":[{"agency":"PEF","code":"2995"},{"agency":"FReSH","code":"FRESH-PEF2995"}]},"title":"Incidence study with population of Rhone-Alpes region of cancers eligible for hadrontherapy by proton or carbon ions. Description of Tumors and patients characteristics","alternate_title":"EpiHadron"},"study_authorization":{"agency":[]},"authoring_entity":[{"name":"Pascal;POMMIER","firstname":"Pascal","lastname":"POMMIER","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01cmnjq37","role":"organisation id"},{"title":"SIREN","uri":"779924133","role":"organisation id"}],"email":"pommier@lyon.fnclcc.fr","affiliationName":"CENTRE LEON BERARD","PILabo":"Centre L\u00e9on B\u00e9rard","isContact":true},{"name":"St\u00e9phanie;PATIN","firstname":"St\u00e9phanie","lastname":"PATIN","type":"investigator","extlink":[{"title":"SIREN","uri":"130004492","role":"organisation id"}],"email":"","affiliationName":"GROUPEMENT COOPERATION SANITAIRE CENTRE ETOILE","PILabo":"GCS ( Groupment de Coop\u00e9ration Sanitaire) ETOILE","isContact":false}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"GROUPEMENT COOPERATION SANITAIRE CENTRE ETOILE","extlink":[{"title":"SIREN","uri":"130004492","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"GROUPEMENT COOPERATION SANITAIRE CENTRE ETOILE","extlink":[{"title":"SIREN","uri":"130004492"}]}]},"distribution_statement":{"contact":[{"name":"Pascal;POMMIER","lastname":"POMMIER","firstname":"Pascal","type":"contact","email":"pommier@lyon.fnclcc.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":"hadrontherapy"},{"keyword":"descriptive prospective survey"},{"keyword":"evaluation."},{"keyword":"Epidemiology"},{"keyword":"incidence"},{"keyword":"ENT"}],"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":"Otolaryngology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9c3a57c5-68bd-4ee7-a9cc-aa8ba07bde94"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010036"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"The main objective is to evaluate in the Rh\u00f4ne-Alpes region the incidence of cancers that have an indication eligible for treatment with hadrontherapy by proton or carbon ions.","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2012-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Auvergne Rh\u00f4ne-Alpes']","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\": \"Type of tumors to identify: A list of the main indications for hadrontherapy by protons and by carbon ions (Appendix 1: list of indications) was developed by experts using data from literature prioritized according to an \\\"\\\"evidence based medicine\\\"\\\" type analysis and based on rendered or expected service criteria (survival and quality of life), (Appendix 2: Literature review method).   Criteria for \\\"\\\"patient\\\"\\\" inclusion The study will be carried out with adult and child subjects, with no age limit, who have indications of hadrontherapy, whose dossiers were able to be discussed by experts at a preliminary pluridisciplinary concertation meeting (RCP).  Subjects must have a general and psychological condition that is compatible with hadrontherapy (good compliance, possible follow-up, accept to travel where applicable) and absence of co-morbidities that are life-threatening.   Criteria for \\\"\\\"tumor\\\"\\\" inclusion The characteristics common to the pathologies to be identified are as follows:  Inoperable tumors, which belong to a pathological group recognized as radio-resistant, at the early stage of development (locoregional stage) or recurring or local relapse, with a low metastatic potential or with an M+ dissemination controlled by medical treatments.  \",\n    \"clusion_E\": \"Tumors: Choroidal melanomas are excluded from the study. Patients: General or psychological condition that is not compatible or threatening co-morbidities.\"\n}","data_kind":"['Clinical data','Biological data','Socio-demographic data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth care consumption and services\r\nOthers"}]},"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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"800"},"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":"","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":"05-08-2011","lastUpdatedAuto":null,"lastUpdatedManual":"10-07-2012","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"List of publications in HAL","link":"http:\/\/tinyurl.com\/Hal-EPIHADRON"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Other"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"prospective, continuous","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Rh\u00f4ne-Alpes"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"anatomopathological results","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}