{"doc_desc":{"title":"Registre R\u00e9gional des H\u00e9mopathies Malignes de Basse Normandie (registre qualifi\u00e9)","idno":"FRESH-PEF203-en","producers":[{"name":"Xavier TROUSSARD","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE CAEN NORMANDIE (CHU)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF203-en","IDno":{"metadata_no":[{"agency":"PEF","code":"203"},{"agency":"FReSH","code":"FRESH-PEF203"}]},"title":"Registre R\u00e9gional des H\u00e9mopathies Malignes de Basse Normandie (registre qualifi\u00e9)","alternate_title":"RRHMBN"},"study_authorization":{"agency":[]},"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":"Yes"},{"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":"Yes"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"Epidemiology"},{"keyword":"Specialist Registry"},{"keyword":"Lower Normandy"}],"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":"Hematology","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":"Neoplasms of haematopoietic or lymphoid tissues","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/944754984","title":"CIM-11"}]}],"purpose":"Objectives of the Lower Normandy Specialist Regional Registry for Hematology in terms of public health (surveillance, evaluation) 1) Descriptive epidemiology and temporal and spatial monitoring of all hematological malignancies in Lower Normandy: Hodgkin's lymphoma, non-Hodgkin's malignant lymphoma, acute and chronic leukemia including chronic lymphocytic leukemia, multiple myeloma of the bones, myelodysplastic and myeloproliferative syndromes. 2) Study of the risk factors of hematological malignancies. In view of the existence in Lower Normandy of nuclear sites in the Nord-Cotentin (AREVA NC La Hague plant, Flamanville plant, ANDRA low- and intermediate-level radioactive waste repository, military arsenal servicing nuclear submarines), extra careful monitoring of hematological malignancies is carried out around these sites by the RRHMBN. Mapping of hematological malignancies is carried out in this context - in both children and adults. This does not only concern leukemia, but also all hematological malignancies, including lymphoma. Given the installation of the very high voltage line corridor between the Flamanville plant and Brittany, the RRHMBN has set up a \"zero point\" field for hematological malignancies in the corresponding zone. This starting point will form a reference for any subsequent research. 3) Evaluation of hematological malignancy treatment in different populations (elderly people, countryside dwellers) in Lower Normandy and study of the care streams and type of treatment depending on age, residential area and type of HM. This research will be performed jointly by all of the Lower Normandy registries brought together under a Federation as well as by the FRANCIM network, associating all accredited registries.","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":"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\": \"All incident cases of hematological malignancies (HMs) as well as any previous personal HMs, previous and subsequent personal solid cancers and any family solid cancers or HMs.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data','Socio-demographic data']","quality_statement":{"standards":[{"name":"['ICDO-3 classification and ADICAP']","committee":"","governance":""}],"other_quality_statement":""}},"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":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Medico-administrative database"]}],"target_sample_size":"[10000-20000[ individuals","response_rate":"1997- 2005 : 7341"},"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":"Contact the scientist in charge","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":"20-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"07-09-2017","isContributorPI":"No","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)","Private non-profit","Public (France)","Public (France)"],"otherFundingAgentType":["","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"No"},"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":"Active data collection - List of cases provided by all regional laboratories - Visit and auditing of records - Coding according to ICD-O-3 - Encrypted file (DIM) Hematological (Xavier Troussard) and epidemiological (Albert Collignon) expertise","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Yes"},"geographicalCoverage":{"geoDetail":"Lower-Normandy: Calvados, Manche and Orne d\u00e9partements, or a population of around 1.5 million inhabitants."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"All necessary paraclinical data for diagnosing and monitoring each type of hematological malignancy","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}