{"doc_desc":{"title":"Etude longitudinale sur des patients atteints d\u2019ichtyoses h\u00e9r\u00e9ditaires","idno":"FRESH-PEF5215-fr","producers":[{"name":"Juliette MAZEREEUW-HAUTIER","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5215-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5215"},{"agency":"FReSH","code":"FRESH-PEF5215"}]},"title":"Etude longitudinale sur des patients atteints d\u2019ichtyoses h\u00e9r\u00e9ditaires","alternate_title":""},"study_authorization":{"agency":[{"name":"Autre"}]},"authoring_entity":[{"name":"Juliette;MAZEREEUW-HAUTIER","firstname":"Juliette","lastname":"MAZEREEUW-HAUTIER","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/017h5q109","role":"organisation id"},{"title":"SIREN","uri":"263100125","role":"organisation id"}],"email":"Mazereeuw-hautier.j@chu-toulouse.fr","affiliationName":"chu","PILabo":"CHU \/ Unit\u00e9 \u00ab Diff\u00e9renciation Epidermique et Autoimmunit\u00e9 Rhumato\u00efde \u00bb (UDEAR) UMR 5165 CNRS \u2013 1056 INSERM - Universit\u00e9 Toulouse III, Equipe \u00ab K\u00e9ratinocyte granuleux et barri\u00e8re \u00e9pidermique \u00bb (N Jonca)","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/017h5q109","role":"sponsor id"},{"title":"SIREN","uri":"263100125","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Juliette;MAZEREEUW-HAUTIER","lastname":"MAZEREEUW-HAUTIER","firstname":"Juliette","type":"contact","email":"Mazereeuw-hautier.j@chu-toulouse.fr","affiliationName":"chu","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/017h5q109","role":"organisation id","title":"ROR"},{"uri":"263100125","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"h\u00e9r\u00e9ditaire"},{"keyword":"\u00e9volution"},{"keyword":"complications"}],"topics":[{"topic":"Dermatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5375c411-6db9-40ed-a854-6554102a587b"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D003880"}]},{"topic":"Ichtyose","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/931401247","title":"CIM-11"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"Disposer pour l'ichtyose h\u00e9r\u00e9ditaire d\u2019une base de donn\u00e9es exploitables sur laquelle pourront s\u2019appuyer des projets de recherche ult\u00e9rieurs ; tant \u00e9pid\u00e9miologiques, cliniques (suivi de l\u2019\u00e9volution de la maladie et de la survenue de complications) que physiopathologiques ou th\u00e9rapeutiques.","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\": \"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\": \"Tout patient atteint d\u2019ichtyose h\u00e9r\u00e9ditaire quels que soient la forme clinique, la s\u00e9v\u00e9rit\u00e9, l\u2019\u00e2ge, le sexe, l\u2019\u00e9volutivit\u00e9 de la maladie, le traitement (afin que la cohorte soit large et repr\u00e9sentative). Patients venant en consultation ou en hospitalisation dans le Centre de R\u00e9f\u00e9rence ou les autres centres fran\u00e7ais, au cours d\u2019une 1\u00e8re visite ou d\u2019un suivi m\u00e9dical. Signature du consentement de participation \u00e0 l\u2019\u00e9tude.\",\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','Autre']","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\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"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\":\"MeasurementsAndTests.Physical\",\"vocab\":\"CESSDA\"},\"value\":\"Mesures physiques\/biologiques (tension art\u00e9rielle, poids, biochimie, imagerie...)\"}","{\"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":"100"},"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 co-disponibles entre l\u2019\u00e9quipe du CRMRP et celle de l\u2019INSERM. Peuvent constituer une base de donn\u00e9es permettant la r\u00e9alisation d\u2019\u00e9tudes relatives \u00e0 l\u2019ichtyose par ces 2 unit\u00e9s conjointement. Il n\u2019est pas pr\u00e9vu de cession de ces donn\u00e9es \u00e0 d\u2019autres chercheurs pour la r\u00e9alisation de travaux de recherche sauf dans le cadre d\u2019un projet collaboratif.","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":"27-12-2012","lastUpdatedAuto":null,"lastUpdatedManual":"08-08-2014","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"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":"Par le m\u00e9decin lors de la visite annuelle. Les donn\u00e9es sont saisies en temps r\u00e9el dans une base de donn\u00e9es Excel des caract\u00e9ristiques cliniques et biologiques.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"suivi biologique habituel","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}