{"doc_desc":{"title":"Registre R\u00e9gional des H\u00e9mopathies Malignes de Basse Normandie (Derni\u00e8re qualification du Registre 2019-2024)","idno":"FRESH-PEF203-fr","producers":[{"name":"Xavier TROUSSARD","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF203-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"203"},{"agency":"FReSH","code":"FRESH-PEF203"}]},"title":"Registre R\u00e9gional des H\u00e9mopathies Malignes de Basse Normandie (Derni\u00e8re qualification du Registre 2019-2024)","alternate_title":"RRHMBN"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Edouard;CORNET","PILabo":"CHU de Caen \/ Registre R\u00e9gional des H\u00e9mopathies Malignes de Basse Normandie","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","extlink":[{"title":"ORCID","uri":"0000-0003-1667-3421","role":"pi id"},{"title":"IdRef","uri":"20471172X","role":"pi id"},{"title":"SIREN","uri":"261400931","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"cornet-e@chu-caen.fr","isContact":"Oui"},{"type":"investigator","name":"Xavier;TROUSSARD","PILabo":"CHU de Caen \/ Laboratoire d\u2019H\u00e9matologie","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","extlink":[{"title":"ORCID","uri":"0000-0001-6863-9992","role":"pi id"},{"title":"IdRef","uri":"074631500","role":"pi id"},{"title":"SIREN","uri":"261400931","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"troussard-x@chu-caen.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/027arzy69","role":"sponsor id"},{"title":"SIREN","uri":"261400931","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/027arzy69"},{"title":"SIREN","uri":"261400931"}]},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]},{"name":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rkrv905"},{"title":"SIREN","uri":"775664717"}]},{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]},{"name":"UNIVERSITE DE CAEN NORMANDIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/051kpcy16"},{"title":"SIREN","uri":"191414085"}]}]},"distribution_statement":{"contact":[{"name":"Edouard;CORNET","email":"cornet-e@chu-caen.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/027arzy69","role":"organisation id","title":"ROR"},{"uri":"261400931","role":"organisation id","title":"SIREN"}]},{"name":"Xavier;TROUSSARD","email":"troussard-x@chu-caen.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/027arzy69","role":"organisation id","title":"ROR"},{"uri":"261400931","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Registre sp\u00e9cialis\u00e9"},{"keyword":"Basse Normandie"},{"keyword":"Epid\u00e9miologie"},{"keyword":"Hematologie"}],"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":"H\u00e9matologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9239f328-78c9-40a5-a0b9-8e66fd9b6245"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006402"}]},{"topic":"Tumeurs de tissus h\u00e9matopo\u00ef\u00e9tiques ou lympho\u00efdes","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/944754984","title":"CIM-11"}]},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"}],"purpose":"Objectifs du Registre R\u00e9gional de Basse-Normandie sp\u00e9cialis\u00e9 en h\u00e9matologie en termes de sant\u00e9 publique (surveillance, \u00e9valuation) 1) \u00c9pid\u00e9miologie descriptive et surveillance temporelle et spatiale de toutes les h\u00e9mopathies malignes en Basse-Normandie : lymphomes de Hodgkin, lymphomes malins non hodgkiniens, leuc\u00e9mies aigues et chroniques dont la leuc\u00e9mie lympho\u00efde chronique, my\u00e9lome multiple des os, syndromes my\u00e9lodysplasiques et syndromes my\u00e9loprolif\u00e9ratifs. 2) Etude des facteurs de risque des h\u00e9mopathies malignes. Compte tenu de la pr\u00e9sence en Basse-Normandie de sites nucl\u00e9aires dans le Nord-Cotentin (usine AREVA NC de La Hague, Centrale de Flamanville, Centre de stockage des d\u00e9chets radioactifs de faible et moyenne activit\u00e9 de l\u2019ANDRA, arsenal militaire assurant l\u2019entretien des sous-marins nucl\u00e9aires), une surveillance toute particuli\u00e8re des h\u00e9mopathies malignes autour de ces sites est effectu\u00e9e par le RRHMBN. Une cartographie des h\u00e9mopathies malignes est r\u00e9alis\u00e9e dans ce contexte non seulement chez l'enfant mais aussi chez l'adulte. Elle concerne non seulement les leuc\u00e9mies mais aussi l'ensemble des h\u00e9mopathies malignes, dont les lymphomes. Compte tenu de la mise en place du couloir de ligne \u00e0 tr\u00e8s haute tension entre la centrale de Flamanville et la Bretagne, la mise en place d\u2019un \u00ab point z\u00e9ro \u00bb des h\u00e9mopathies malignes dans la zone correspondant est assur\u00e9e par le RRHMBN. Ce point de d\u00e9part servira de r\u00e9f\u00e9rence pour toute \u00e9tude ult\u00e9rieure. 3) \u00c9valuation de la prise en charge des h\u00e9mopathies malignes dans diff\u00e9rentes populations (personnes \u00e2g\u00e9es, personnes domicili\u00e9es en zone rurale) en Basse Normandie et \u00e9tude des fili\u00e8res de soins et du type de traitement selon l\u2019\u00e2ge, le secteur d\u2019habitat, le type d\u2019HM. Ces travaux s'effectuent en collaboration avec l'ensemble des registres de Basse-Normandie r\u00e9unis en F\u00e9d\u00e9ration mais aussi avec le r\u00e9seau FRANCIM, regroupant l'ensemble des registres labellis\u00e9s.","abstract":"","coll_dates":[{"start":"1997-01-01","end":"2014-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Normandie']","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\": \"Tous les cas incidents d\u2019h\u00e9mopathies malignes; aigu\u00ebs et chroniques (HM) observ\u00e9es chez les patients domicili\u00e9s en Basse-Normandie au diagnostic depuis 1997\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"['classification ICDO-3 et ADICAP']","committee":"","governance":""}],"other_quality_statement":"['Proc\u00e9dure RGPD appliqu\u00e9e']"}},"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":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Base m\u00e9dico-administrative"]}],"target_sample_size":"[10000-20000[ individus","response_rate":"1997- 2018 : aux alentours de 20 000 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":"Contacter le responsable scientifique","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":"20-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"07-09-2017","isContributorPI":"Non","contributorName":"Xavier TROUSSARD","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/tinyurl.com\/PUBMED-RRHMBN"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Priv\u00e9 \u00e0 but non lucratif","Public (France)","Public (France)"],"otherFundingAgentType":["","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Non"},"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":"Recueil actif des donn\u00e9es- Liste de cas fournies par l'ensemble des laboratoires de la r\u00e9gion- Visite et contr\u00f4le des dossiers-Codage suivant ICDO-3- Fichier crypt\u00e9 (DIM)Expertise h\u00e9matologique (Xavier Troussard) et \u00e9pid\u00e9miologique (Albert Collignon)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Oui"},"geographicalCoverage":{"geoDetail":"Normandie Occidentale (Basse-Normandie) : D\u00e9partements du Calvados (14), de la Manche (50) et de l\u2019Orne (61) soit une population d'environ 1.500 000 habitants"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Toutes les donn\u00e9es paracliniques n\u00e9cessaires au diagnostic et au suivi de chaque type d'h\u00e9mopathie maligne","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}