{"doc_desc":{"title":"Registre des patients jeunes atteints de d\u00e9mence au centre national de r\u00e9f\u00e9rence pour les maladies d'Alzheimer jeunes et apparent\u00e9es (CNR-MAJ)","idno":"FRESH-PEF5391-fr","producers":[{"name":"Florence PASQUIER","affiliation":"UNIVERSITE DE LILLE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5391-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5391"},{"agency":"FReSH","code":"FRESH-PEF5391"}]},"title":"Registre des patients jeunes atteints de d\u00e9mence au centre national de r\u00e9f\u00e9rence pour les maladies d'Alzheimer jeunes et apparent\u00e9es (CNR-MAJ)","alternate_title":"YOD : Young Onset Dementia"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"},{"name":"Autre"}]},"authoring_entity":[{"type":"investigator","name":"Florence;RICHARD","PILabo":"Universit\u00e9 Lille Nord de France, Lille2 et Institut National de Sant\u00e9 et Recherche \/ UMR INSERM 744","affiliationName":"UNIVERSITE DE LILLE","extlink":[{"title":"ORCID","uri":"0000-0002-0848-0091","role":"pi id"},{"title":"IdRef","uri":"161593771","role":"pi id"},{"title":"SIREN","uri":"130029754","role":"organisation id"},{"title":"RNSR","uri":"200616418Z","role":"labo id"}],"email":"florence.richard@pasteur-lille.fr","isContact":"Oui"},{"type":"investigator","name":"Florence;PASQUIER","PILabo":"Universit\u00e9 Lille Nord de France \/ EA1046","affiliationName":"UNIVERSITE DE LILLE","extlink":[{"title":"ORCID","uri":"0000-0001-9880-9788","role":"pi id"},{"title":"IdRef","uri":"03434991X","role":"pi id"},{"title":"SIREN","uri":"130029754","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"florence.pasquier@chru-lille.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"UNIVERSITE DE LILLE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02kzqn938","role":"sponsor id"},{"title":"SIREN","uri":"130029754","role":"sponsor id"}],"role":"sponsor"},{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02ppyfa04","role":"sponsor id"},{"title":"SIREN","uri":"265906719","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Florence;RICHARD","email":"florence.richard@pasteur-lille.fr","type":"contact","affiliationName":"UNIVERSITE DE LILLE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02kzqn938","role":"organisation id","title":"ROR"},{"uri":"130029754","role":"organisation id","title":"SIREN"}]},{"name":"Florence;PASQUIER","email":"florence.pasquier@chru-lille.fr","type":"contact","affiliationName":"UNIVERSITE DE LILLE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02kzqn938","role":"organisation id","title":"ROR"},{"uri":"130029754","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Maladie d'Alzheimer"},{"keyword":"D\u00e9mence fronto-temporale"},{"keyword":"D\u00e9mence vasculaire"},{"keyword":"D\u00e9mence \u00e0 corps de Lewy"},{"keyword":"D\u00e9but pr\u00e9coce"},{"keyword":"Facteurs pronostiques"},{"keyword":"Retentissement social"},{"keyword":"Parcours de soins"},{"keyword":"D\u00e9mences"},{"keyword":"G\u00e9n\u00e9tique"}],"topics":[{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"Psychiatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3de50dee-da1c-4791-a386-56bca24a5fed"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D011570"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"}],"purpose":"Collecte d'informations m\u00e9dicales, m\u00e9dico-sociales, m\u00e9dico-\u00e9conomiques, neuropsychologiques, biologiques et d'imagerie de patients consultant au centre national de r\u00e9f\u00e9rence pour les maladies d'Alzheimer jeunes et apparent\u00e9es (CNR-MAJ) dont les troubles ont d\u00e9but\u00e9 avant l'\u00e2ge de 60 ans. Ces patients seront suivis tous les 6 mois jusqu'au d\u00e9c\u00e8s. Un pr\u00e9l\u00e8vement c\u00e9r\u00e9bral de confirmation diagnostique sera r\u00e9alis\u00e9 pour les personnes ayant donn\u00e9 leur accord. L'objectif principal est de connaitre le parcours m\u00e9dical et m\u00e9dico-social des patients jeunes atteints de d\u00e9mences. Les objectifs secondaires sont d'\u00e9tablir les facteurs associ\u00e9s au d\u00e9lai du diagnostic, et de constituer une base de ressources cliniques, biologiques et d'imagerie pour ces d\u00e9mences survenant chez des sujets jeunes.","abstract":"","coll_dates":[{"start":"2009-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","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\": \"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Patient volontaires ayant un syndrome d\u00e9mentiel dont les premiers sympt\u00f4mes ont d\u00e9but\u00e9 avant 60 ans - Consultant au CNR-MAJ (Lille-Rouen-Paris Salp\u00eatri\u00e8re)\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","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\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":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"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":[],"target_sample_size":"< 500 individus","response_rate":"338 (dont\/with 220 Alzheimer)"},"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\":\"A d\u00e9finir\",\"extLink\":[]}"},"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":"09-01-2013","lastUpdatedAuto":null,"lastUpdatedManual":"18-01-2013","isContributorPI":"Non","contributorName":"Florence PASQUIER","contributorAffiliation":"UNIVERSITE DE LILLE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["","",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"Des donn\u00e9es standardis\u00e9es m\u00e9dicales, sociales, neuropsychologiques, ainsi que l'histoire personnelle et familiale sont recueillies \u00e0 l'inclusion et lors de chaque suivi. Ces donn\u00e9es sont collect\u00e9es sur papier. Ces donn\u00e9es seront valid\u00e9es et saisies dans un e-CRF dans chaque centre par un assistant de recherche clinique. Le recueil des donn\u00e9es sera r\u00e9alis\u00e9e de fa\u00e7on standardis\u00e9e.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Lille, Rouen ou Paris Salp\u00eatri\u00e8re"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Pr\u00e9l\u00e8vements g\u00e9n\u00e9tiques pour les patients Alzheimer ou DFT","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}