{"doc_desc":{"title":"Etude longitudinale sur l'Evaluation de l'Atteinte Syst\u00e9mique et de l'\u00e9volution des patients atteints de Syndrome de Sj\u00f6gren primitif","idno":"FRESH-PEF6873-fr","producers":[{"name":"Jacques-Eric GOTTENBERG","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF6873-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"6873"},{"agency":"FReSH","code":"FRESH-PEF6873"}]},"title":"Etude longitudinale sur l'Evaluation de l'Atteinte Syst\u00e9mique et de l'\u00e9volution des patients atteints de Syndrome de Sj\u00f6gren primitif","alternate_title":"ASSESS"},"study_authorization":{"agency":[{"name":"CPP"}]},"authoring_entity":[{"name":"Jacques-Eric;GOTTENBERG","firstname":"Jacques-Eric","lastname":"GOTTENBERG","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04bckew43","role":"organisation id"},{"title":"SIREN","uri":"266700574","role":"organisation id"}],"email":"jacques-eric.gottenberg@chru-strasbourg.fr","affiliationName":"chu","PILabo":"CHU \/ U1109 Immuno-rhumatologie mol\u00e9culaire","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"LES HOPITAUX UNIVERSITAIRES DE STRASBOURG (HUS)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04bckew43","role":"sponsor id"},{"title":"SIREN","uri":"266700574","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"}]}]},"distribution_statement":{"contact":[{"name":"Jacques-Eric;GOTTENBERG","lastname":"GOTTENBERG","firstname":"Jacques-Eric","type":"contact","email":"jacques-eric.gottenberg@chru-strasbourg.fr","affiliationName":"chu","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04bckew43","role":"organisation id","title":"ROR"},{"uri":"266700574","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Pr\u00e9valence"},{"keyword":"facteur de risque"}],"topics":[{"topic":"Immunologie m\u00e9dicale","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7a3cf568-46ba-4840-be8f-f22fc030139f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]}],"purpose":"D\u00e9terminer pour la premi\u00e8re fois de mani\u00e8re prospective, la pr\u00e9valence et les facteurs de risque de complications syst\u00e9miques et de lymphomes au cours du syndrome de SJ\u00f6gren primitif.","abstract":"","coll_dates":[{"start":"2006-01-01","end":"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 (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\": \" homme ou femme - adulte - patient dans un centre tertiaire des maladies autoimmunes\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques']","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"}]},"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":"395"},"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":"Donn\u00e9es non disponibles pour d&#x27;autres chercheurs, sauf si demande d&#x27;autorisation d&#x27;extraction des donn\u00e9es par un des PI aupr\u00e8s de l&#x27;investigateur coordonnateur.","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":"01-07-2013","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2019","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"List of publications in HAL","link":"http:\/\/tinyurl.com\/Hal-ASSESS"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Cahier d'observation (CRF) papier, compl\u00e9t\u00e9 par l'investigateur ou co-investigateur. Les CRF sont envoy\u00e9s ensuite au data manager pour la saisie.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France (15 Centres)"},"dataTypes":{"clinicalDataDetails":"Compte rendu hospitalier, examens ophtalmologiques, biopsies, bilans biologiques.","biologicalDataDetails":"","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}