{"doc_desc":{"title":"Etude longitudinale sur des sujets pr\u00e9sentant des indications d\u2019hadronth\u00e9rapie","idno":"FRESH-PEF2995-fr","producers":[{"name":"Pascal POMMIER","affiliation":"CENTRE LEON BERARD"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF2995-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"2995"},{"agency":"FReSH","code":"FRESH-PEF2995"}]},"title":"Etude longitudinale sur des sujets pr\u00e9sentant des indications d\u2019hadronth\u00e9rapie","alternate_title":"EpiHadron"},"study_authorization":{"agency":[{"name":"CNIL"}]},"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":"Portail Epid\u00e9miologie France (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":"hadronth\u00e9rapie"},{"keyword":"enqu\u00eate prospective descriptive"},{"keyword":"\u00e9valuation."},{"keyword":"Epid\u00e9miologie"},{"keyword":"incidence"},{"keyword":"ORL"}],"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":"Oto-rhino-laryngologie","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":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"L\u2019objectif principal est d\u2019\u00e9valuer en r\u00e9gion Rh\u00f4ne-Alpes l\u2019incidence des cancers qui pr\u00e9sentent une indication jug\u00e9e prioritaire pour un traitement par hadronth\u00e9rapie par protons ou ions carbone.","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":"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\": \"Type de tumeurs \u00e0 identifier: Une liste des  principales indications d\u2019hadronth\u00e9rapie par protons et par ions carbone (Annexe 1 : liste des indications) a \u00e9t\u00e9 \u00e9labor\u00e9e par des experts \u00e0 partir des donn\u00e9es de la litt\u00e9rature hi\u00e9rarchis\u00e9e selon une analyse de type \u00ab evidence based medicine \u00bb et reposant sur des crit\u00e8res de service m\u00e9dical rendu ou attendu (survie et qualit\u00e9 de vie), (Annexe 2: M\u00e9thode de revue de litt\u00e9rature).   Crit\u00e8res d\u2019inclusion \u00ab Patients \u00bb  L\u2019\u00e9tude sera r\u00e9alis\u00e9e aupr\u00e8s de sujets adultes et enfants, sans limite d\u2019\u00e2ge, pr\u00e9sentant des indications d\u2019hadronth\u00e9rapie, dont les dossiers auront pu \u00eatre discut\u00e9s par des experts au cours d\u2019une RCP primaire.  Les sujets devront pr\u00e9senter un \u00e9tat g\u00e9n\u00e9ral et psychologique compatible avec une hadronth\u00e9rapie (bonne compliance, suivi possible, acceptation du d\u00e9placement \u00e9ventuel) et une absence de co- morbidit\u00e9s mena\u00e7ant le pronostic vital.   Crit\u00e8res d\u2019inclusion \u00ab Tumeurs \u00bb Les caract\u00e9ristiques communes aux pathologies \u00e0 identifier sont les suivantes:  Tumeurs  inop\u00e9rables, qui appartiennent \u00e0 un groupe pathologique reconnu comme radio-r\u00e9sistant, au stade primaire d\u2019\u00e9volution (stade  locor\u00e9gional) ou en r\u00e9cidive ou rechute locale, ayant un faible potentiel m\u00e9tastatique ou avec une diss\u00e9mination M+ contr\u00f4l\u00e9e par les traitements m\u00e9dicaux.  \",\n    \"clusion_E\": \"Tumeurs : Les m\u00e9lanomes choro\u00efdiens sont exclus de l\u2019\u00e9tude  Patients : Etat g\u00e9n\u00e9ral ou psychologique non compatibles ou comorbidit\u00e9s mena\u00e7antes\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques']","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\nConsommation de soins\/services de sant\u00e9\r\nAutres"}]},"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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"800"},"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":"","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":"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":["Autre"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"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":"prospectif, en continu du 1er septembre 2010 au 31 aout 2012","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Rh\u00f4ne-Alpes"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"r\u00e9sultats anatomopathologie","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}