{"study_desc":{"title_statement":{"idno":"FRESH-PEF73194-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73194"},{"agency":"FReSH","code":"FRESH-PEF73194"}]},"title":"Cohorte de patients atteints d'une colite microscopique (lymphocytaire ou de collag\u00e8ne)","alternate_title":""},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Gilles;MACAIGNE","firstname":"Gilles","lastname":"MACAIGNE","type":"investigator","extlink":[{"title":"SIREN","uri":"267709343","role":"organisation id"},{"uri":"229826822","role":"pi id","title":"IdRef"}],"email":"gmacaigne@ch-lagny77.fr","affiliationName":"CENTRE HOSPITALIER DE MARNE-LA-VALLEE","PILabo":"Marne-la-Vall\u00e9e Hospital \/ Gastroenterology Department","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER DE MARNE-LA-VALLEE","extlink":[{"title":"SIREN","uri":"267709343","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"FERRING SAS","extlink":[{"title":"SIREN","uri":"322624735"}]}]},"distribution_statement":{"contact":[{"name":"Gilles;MACAIGNE","lastname":"MACAIGNE","firstname":"Gilles","type":"contact","email":"gmacaigne@ch-lagny77.fr","affiliationName":"CENTRE HOSPITALIER DE MARNE-LA-VALLEE","contactPointLabo":"","extlink":[{"uri":"267709343","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"diarrh\u00e9e"},{"keyword":"trouble intestin"},{"keyword":"cohorte"},{"keyword":"colite"}],"topics":[{"topic":"Gastroent\u00e9rologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/a3898340-a42d-4f5e-a822-1de204a9a867"},{"title":"MeSH","uri":"D005762"}]},{"topic":"Colite microscopique","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1122828822","title":"CIM-11"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques : Pr\u00e9disposition g\u00e9n\u00e9tique","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"L'objectif est de d\u00e9crire les caract\u00e9ristiques d'une cohorte de patients atteints de colite microscopique (MC; lymphocytaire (LC) ou de collag\u00e8ne (CC) colites) et de les comparer avec les patients souffrant de troubles fonctionnels de l'intestin avec diarrh\u00e9e","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2012-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Masculin\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"F\u00e9minin\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Adulte (19 \u00e0 24 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adulte (25 \u00e0 44 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Adulte (45 \u00e0 64 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}}],\"level_type_clusion_I\":\"Patients\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Patients ayant au moins trois selles par jour avec variation de leur consistance;  Dur\u00e9e de la maladie sup\u00e9rieur \u00e0 4 semaines Coloscopie normale ou quasi-normale\",\"clusion_E\":\"\"}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques','Donn\u00e9es de sant\u00e9 rapport\u00e9es par les participants de l'\u00e9tude']","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\"}","{\"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":"433"},"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\"}]}","notes":""},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"Import\u00e9e","creationDate":"11-08-2015","lastUpdatedManual":"20-06-2016","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25001258"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"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":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Histoire personnelle de l'appendicectomie, chol\u00e9cystectomie, IMC , le nombre de selles quotidiennes (3-4, 5-9, 10 ou plus), l'existence de selles nocturnes, douleurs abdominale. Date du diagnostic, Habitudes Tabacs, perte de poids. M\u00e9dicaments","biologicalDataDetails":"La prot\u00e9ine C r\u00e9active, de potassium s\u00e9rique, l'h\u00e9moglobine, les leucocytes et nombre d'\u00e9osinophiles, et l'hormone stimulant la thyro\u00efde","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}