{"doc_desc":{"title":"Evaluation et Suivi de POlyarthrites Indiff\u00e9renci\u00e9es R\u00e9centes","idno":"FRESH-PEF6711-fr","producers":[{"name":"Bernard COMBE","affiliation":"SOCIETE FRAN\u00c7AISE DE RHUMATOLOGIE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF6711-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"6711"},{"agency":"FReSH","code":"FRESH-PEF6711"}]},"title":"Evaluation et Suivi de POlyarthrites Indiff\u00e9renci\u00e9es R\u00e9centes","alternate_title":"ESPOIR"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"},{"name":"Autre"}]},"authoring_entity":[{"name":"Bernard;COMBE","firstname":"Bernard","lastname":"COMBE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04g47ec58","role":"organisation id"}],"email":"b-combe@chu-montpellier.fr","affiliationName":"SOCIETE FRAN\u00c7AISE DE RHUMATOLOGIE","PILabo":"Soci\u00e9t\u00e9 Fran\u00e7aise de Rhumatologie","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"SOCIETE FRAN\u00c7AISE DE RHUMATOLOGIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04g47ec58","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"SOCIETE FRAN\u00c7AISE DE RHUMATOLOGIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04g47ec58"}]},{"name":"ABBVIE","extlink":[{"title":"SIREN","uri":"750775660"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"LILLY FRANCE","extlink":[{"title":"SIREN","uri":"609849153"}]},{"name":"PFIZER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"},{"title":"SIREN","uri":"433623550"}]}]},"distribution_statement":{"contact":[{"name":"Bernard;COMBE","lastname":"COMBE","firstname":"Bernard","type":"contact","email":"b-combe@chu-montpellier.fr","affiliationName":"SOCIETE FRAN\u00c7AISE DE RHUMATOLOGIE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04g47ec58","role":"organisation id","title":"ROR"}]},{"name":"Nathalie;RINCHEVAL","lastname":"RINCHEVAL","firstname":"Nathalie","type":"contact","email":"nathalie.rincheval@inserm.fr","affiliationName":"UNIVERSITE DE MONTPELLIER","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/051escj72","role":"organisation id","title":"ROR"},{"uri":"130029796","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"polyarthrite rhumato\u00efde"},{"keyword":"d\u00e9butantes"},{"keyword":"m\u00e9dico-\u00e9conomie"},{"keyword":"Cohorte"},{"keyword":"PR"},{"keyword":"diagnostic"}],"topics":[{"topic":"Rhumatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bfb0bafd-7894-45ba-84fc-ddab5fd6c537"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D012219"}]},{"topic":"Arthropathies inflammatoires","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/396939646","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Constituer une cohorte multicentrique fran\u00e7aise d'arthrites d\u00e9butantes (\u00e9voluant depuis moins de 6 mois) servant de base de donn\u00e9es pour des \u00e9tudes d'ordre diagnostique, prognostique, m\u00e9dico-\u00e9conomique et pathog\u00e8nique.","abstract":"","coll_dates":[{"start":"2002-01-01","end":"2025-01-01"}],"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 (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\": \" homme ou femme - \u00e2g\u00e9 entre 18 et 70 ans - affili\u00e9 \u00e0 un r\u00e9gime de s\u00e9curit\u00e9 sociale - ayant au moins 2 arthrites depuis moins de 6 semaines\\\/mois - n'ayant re\u00e7u aucun traitement de fond ou cortico\u00efde au cours des 6 derniers mois  (sauf pour des traitements d'une dur\u00e9e inf\u00e9rieure \u00e0 2 semaines et infiltration si plus de 4 semaines avant l'inclusion; sauf pour de la corticoth\u00e9rapie orale d'une dur\u00e9e inf\u00e9rieure \u00e0 2 semaines, \u00e0 dose moyenne inf\u00e9rieure \u00e0 20mg\\\/jour, arr\u00eat\u00e9e au moins 15 jours avant l'inclusion)\",\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":"['Data management r\u00e9gulier sur les donn\u00e9es manquantes, les incoh\u00e9rences, la saisie, le stock radio, effectu\u00e9 par l\\'ARC coordonnateur. Possibilit\u00e9 pour les centres de contr\u00f4les des donn\u00e9es manquantes \u00e0 l\\'aide de l\\'outil disponible directement \u00e0 partir du masque ACCESS. Un contr\u00f4le qualit\u00e9 a \u00e9t\u00e9 effectu\u00e9 pendant 4 ans par tirage au sort (ad\u00e9quation des donn\u00e9es du dossier source avec le CRF et du CRF avec le masque de donn\u00e9es. Au vu des bons r\u00e9sultats, ce contr\u00f4le s\\'est transform\u00e9 en visite de monitoring les 4 ann\u00e9es suivantes dans chacun des centres et ensuite par t\u00e9l\u00e9phone ou compte-rendu listant les corrections envoy\u00e9 par mail']"}},"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\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\":\"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":"[500-1000[ individus","response_rate":"813"},"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":"","conditions":"Les donn\u00e9es de projet faisant suite \u00e0 l&#x27;appel \u00e0 projet (2fois\/an) sont adress\u00e9s au pr\u00e9sident du conseil scientifique et sont examin\u00e9s par 2 lecteurs\/tuteurs. L&#x27;accord final est donn\u00e9 en conseil scientifique. Les donn\u00e9es sp\u00e9cifiques sont c\u00e9d\u00e9es apr\u00e8s signature d&#x27;une convention.","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":"17-06-2013","lastUpdatedAuto":null,"lastUpdatedManual":"29-10-2020","isContributorPI":false,"contributorName":"Bernard COMBE","contributorAffiliation":"SOCIETE FRAN\u00c7AISE DE RHUMATOLOGIE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["","",""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/sfr.larhumatologie.fr\/rc\/rhumatologie\/htm\/Article\/2010\/59d645a5cc26d0e80d4052f3ca0a70ab\/src\/htm_fullText\/fr\/Combe%20ESPOIR%20bonsoi_JBS%20271911.pdf"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif","Industrie","Public (France)","Industrie","Industrie"],"otherFundingAgentType":["","","","",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":true},"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":"Donn\u00e9es recueillies sur CRF et saisies sur base de donn\u00e9es Access. Envoi hebdomadaire des donn\u00e9es au centre de coordination.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France CHU Nord (Amiens), CHU Pellegrin Tripode (Bordeaux), CHU La Cavale Blanche (Brest), CHU R.Salengro (Lille), CHU Lapeyronie (Montpellier), CHU St Antoine-Avicenne (Paris), CHU La Piti\u00e9 Salp\u00e9tri\u00e8re (Paris), CHU Cochin (Paris), CHU Bic\u00eatre (Paris), CHU Bichat-Lariboisi\u00e8re-St Joseph (Paris), CHU Bois Guillaume (Rouen), CHU Hautepierre (Strasbourg), CHU Trousseau (Tours)"},"dataTypes":{"clinicalDataDetails":"Traitements comorbidit\u00e9s et ant\u00e9c\u00e9dents, signes associ\u00e9s et activit\u00e9 de la maladie, diagnostic (avis du m\u00e9decin, crit\u00e8res ACR)","biologicalDataDetails":"ADN (tissu et liquide synovial), s\u00e9rums, pr\u00e9l\u00e8vement biologiques usuels: num\u00e9ration de formule sanguine, plaquettes, vitesse de s\u00e9dimentation, C-R\u00e9active Prot\u00e9ine, Aspartate amino transf\u00e9rase, Alanine Amino Transf\u00e9rase, Gamma GT (inclusion), glyc\u00e9mie, facteur rhumato\u00efde, anti-cyclic citrullinated peptide, anticorps antinucleaires (inclusion), anti-DNA natif (inclusion), antig\u00e8nes des leucocytes humains (inclusion) phosphatases alcalins (inclusion), cr\u00e9atine (inclusion)","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}