{"doc_desc":{"title":"Neuropathie ent\u00e9rique","idno":"FRESH-PEF5972-fr","producers":[{"name":"Arnaud BOURREILLE","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5972-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5972"},{"agency":"FReSH","code":"FRESH-PEF5972"}]},"title":"Neuropathie ent\u00e9rique","alternate_title":"NEUROPATHIE ENTERIQUE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Arnaud;BOURREILLE","PILabo":"UMR INSERM U913 CHU \/ INSTITUT DES MALADIES DE L\u2019APPAREIL DIGESTIF (IMAD). SERVICE DE GASTRO-ENTEROLOGIE ET D\u2019ASSISTANCE NUTRITIONNELLE.","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0003-4903-3535","role":"pi id"},{"title":"IdRef","uri":"074716263","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"200816538W","role":"labo id"}],"email":"bp-cic-imad@chu-nantes.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05c1qsg97","role":"sponsor id"},{"title":"SIREN","uri":"264400136","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05c1qsg97"},{"title":"SIREN","uri":"264400136"}]},{"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":"Arnaud;BOURREILLE","email":"bp-cic-imad@chu-nantes.fr","type":"contact","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"donn\u00e9es ph\u00e9notypiques"},{"keyword":"donn\u00e9es d\u00e9mographiques"},{"keyword":"banque informatique"},{"keyword":"s\u00e9jours hospitaliers"},{"keyword":"immunosuppreseurs"},{"keyword":"bioth\u00e9rapies"},{"keyword":"cortico-d\u00e9pendance"},{"keyword":"signes extra-digestifs rhumatologiques"},{"keyword":"cutan\u00e9s"},{"keyword":"occulaires"},{"keyword":"vasculaires."},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"consultation"},{"keyword":"diagnostic"},{"keyword":"chirurgie"},{"keyword":"h\u00e9patiques"}],"topics":[{"topic":"Neurologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"topic":"Gastroent\u00e9rologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/a3898340-a42d-4f5e-a822-1de204a9a867"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005762"}]},{"topic":"Myopathies mitochondriales","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/601991549","title":"CIM-11"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : d\u00e9velopper et agrandir la cohorte et la bio-collection neuropathies ent\u00e9riques chez des patients atteints de MICI et de Maladie de Parkinson (MP). Objectifs secondaires : - \u00c9tudier transcriptomique de la plasticit\u00e9 neuronale et gliale ; - \u00c9tudier et classification des processus neuro-d\u00e9g\u00e9n\u00e9ratifs ; - Corr\u00e9ler des atteintes neuronales avec les param\u00e8tres cliniques et le profil \u00e9volutif.","abstract":"","coll_dates":[{"start":"2009-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Pays de la Loire']","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 (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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Le recrutement concerne tous les patients adultes atteints de MICI et de MP suivis au sein du CHU de Nantes. Les patients seront inclus au moment du diagnostic. Les patients pourront \u00eatre inclus apr\u00e8s le diagnostic de leur maladie si les donn\u00e9es ph\u00e9notypiques prises en compte dans la base de donn\u00e9es sont accessibles dans le dossier source. Un recueil de sang sera effectu\u00e9 au cours d\u2019un pr\u00e9l\u00e8vement motiv\u00e9 pour le suivi de leur maladie. Les pr\u00e9l\u00e9vements biopsiques seront effectu\u00e9s au cours des examens endoscopiques r\u00e9alis\u00e9s pour le suivi classique de la maladie. \",\n    \"clusion_E\": \"patient mineur, absence de consentement \u00e0 participer \u00e0 l\u2019\u00e9tude, suivi impossible, donn\u00e9es ph\u00e9notypiques inaccessibles \u00e0 partir du dossier source, patients atteints de MP sans trouble digestif n\u00e9cessitant une exploration endoscopique\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques. Gestion des donn\u00e9es manquantes par retour au dossier source. Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi. Relance des sujets pour r\u00e9aliser les visites de suivi. R\u00e9alisation d\\'un audit qualit\u00e9 interne par an de la database avec une analyse de 10% des dossiers. Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es.']"}},"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"}]},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"100 patients atteints de MICI et 30 patients atteints de MP ont \u00e9t\u00e9 inclus dans la bio-collection. Ces patients font partie d\u2019une cohorte historique. Les donn\u00e9es ph\u00e9notypiques sont \u00e0 renseigner dans la base de donn\u00e9es informatis\u00e9e."},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"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":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation possible des donn\u00e9es par des industriels","conditions":"Condition d&#x27;acc\u00e8s la biocollection fait partie int\u00e9grante de la biobanque ouest atlantique (boa) en cours de de demande de labellisation aupr\u00e8s du gis ibisa. Les donn\u00e9es seront accessibles \u00e0 d&#x27;autres \u00e9quipes de recherche institutionnelles par contrat. Les donn\u00e9es seront accessibles \u00e0 d&#x27;autres \u00e9quipes de recherche priv\u00e9es par contrat avec le chu.","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":"03-05-2013","lastUpdatedAuto":null,"lastUpdatedManual":"13-05-2015","isContributorPI":"Non","contributorName":"Arnaud BOURREILLE","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["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":"Entretiens : saisie directe Examens cliniques : saisie directe Examens biologiques : saisie directe","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"R\u00e9gion des pays de la Loire"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi tous les 6 mois. Informations recueillies lors de l'examen clinique : les items sont remplis au cours de l'entretien. Les items correspondent \u00e0 ceux de la base de donn\u00e9e. Les patients sont suivis tous les 6 mois et un entretien est r\u00e9alis\u00e9 \u00e0 chaque visite additionnelle. Le d\u00e9tail des items a \u00e9t\u00e9 renseign\u00e9 pr\u00e9c\u00e8demment","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : pr\u00e9l\u00e8vements sanguins (s\u00e9rum 10 ml et sang total 10 ml) biopsies coliques (x6) et\/ou oeso-gastrique (x4)","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}