{"doc_desc":{"title":"Etude longitudinale sur des patients atteints d'ob\u00e9sit\u00e9 s\u00e9v\u00e8re et morbide : bilan, evaluation, suivi","idno":"FRESH-PEF60013-fr","producers":[{"name":"Simon MSIKA","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60013-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60013"},{"agency":"FReSH","code":"FRESH-PEF60013"}]},"title":"Etude longitudinale sur des patients atteints d'ob\u00e9sit\u00e9 s\u00e9v\u00e8re et morbide : bilan, evaluation, suivi","alternate_title":"COLOMBES \/ Cohorte Louis Mourier"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Dominique;DE PROST","firstname":"Dominique","lastname":"DE PROST","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"SIREN","uri":"267500452","role":"organisation id"}],"email":"","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","PILabo":"APHP \/ AP-HP, LABORATOIRE D'H\u00c9MATOLOGIE, H\u00d4PITAL LOUIS MOURIER AP-HP","isContact":false},{"name":"Simon;MSIKA","firstname":"Simon","lastname":"MSIKA","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"SIREN","uri":"267500452","role":"organisation id"}],"email":"simon.msika@aphp.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","PILabo":"APHP \/ SERVICE DE CHIRURGIE, H\u00d4PITAL LOUIS MOURIER AP-HP","isContact":true}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14"},{"title":"SIREN","uri":"267500452"}]}]},"distribution_statement":{"contact":[{"name":"Simon;MSIKA","lastname":"MSIKA","firstname":"Simon","type":"contact","email":"simon.msika@aphp.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"d'interrogatoires"},{"keyword":"histologiques"},{"keyword":"suivi prospectif des sujets"},{"keyword":"facteurs pronostiques"},{"keyword":"facteurs cardiovasculaires"},{"keyword":"m\u00e9taboliques"},{"keyword":"diagnostiques"},{"keyword":"pronostiques"},{"keyword":"donn\u00e9es cliniques"},{"keyword":"biologiques"},{"keyword":"chirurgie bariatrique"},{"keyword":"complications"}],"topics":[{"topic":"Endocrinologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004704"}]},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"Disposer d'une collection de donn\u00e9es cliniques, d'interrogatoires, biologiques, et histologiques, recueillies chez des patients ob\u00e8ses morbides, dans des conditions standardis\u00e9es, avec un suivi prospectif des sujets pendant 10 ans. Objectif secondaire : Mobilisation de sujets volontaires pour participer \u00e0 d'autres projets de recherche sur le th\u00e8me de l\u2019ob\u00e9sit\u00e9 (impact de la chirurgie bariatrique et recherche de facteurs pronostiques de son \u00e9chec ou de son succ\u00e8s; recherche de facteurs cardiovasculaires et m\u00e9taboliques, diagnostiques et pronostiques, associ\u00e9s \u00e0 l'ob\u00e9sit\u00e9 et \u00e0 ses complications, ...)","abstract":"","coll_dates":[{"start":"2005-01-01","end":"2019-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France']","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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"IMC sup\u00e9rieur ou \u00e9gal \u00e0 35 kg\\\/m\u00b2 \u00c2ge : [18-60] ans\",\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 paracliniques (hors biologiques) : Imagerie','Donn\u00e9es paracliniques (hors biologiques) : Exploration fonctionnelle','Donn\u00e9es paracliniques (hors biologiques) : Autre']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['- Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques.- Gestion des donn\u00e9es manquantes par retour au dossier source et\/ou par retour vers le patient et\/ou vers un tiers.- Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi.- Relance des sujets pour r\u00e9aliser les visites de suivi.- V\u00e9rification de tous les cahiers d\\'observation par le m\u00e9decin de recherche clinique avant saisie.- Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es par \u00e9crit.']"}},"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\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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\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":"288"},"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":"","conditions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques ou par des industriels avec \u00e9tablissement d&#x27;un contrat pr\u00e9cisant notamment les modalit\u00e9s temporelles d&#x27;utilisation des donn\u00e9es, apr\u00e8s avis du comit\u00e9 scientifique et de la direction de la recherche clinique de l&#x27;AP-HP.","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"11-08-2014","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/23512861"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":true},"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":"- Auto-questionnaire : saisie manuelle \u00e0 partir d\u2019un questionnaire papier avec double saisie - Entretiens : saisie manuelle \u00e0 partir d\u2019un questionnaire papier avec double saisie - Examens cliniques : saisie manuscrite avec double saisie - Examens biologiques : saisie manuscrite avec double saisie","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Ile de France"},"dataTypes":{"clinicalDataDetails":"- Examen clinique \u00e0 l\u2019inclusion et au cours du suivi tous les ans : morphologie : poids, taille, tour de taille, tour de hanche, tour de cou- Examen cardio-vasculaire : pouls, fr\u00e9quence cardiaque, tension art\u00e9rielle- Examen bucco-dentaire","biologicalDataDetails":"Sanguins (dosages syst\u00e9matiques) :- NFS, h\u00e9mostase- Bilan lipidique- Bilen h\u00e9patique- Fibrinog\u00e8ne, crp-us- Glyc\u00e9mie, insulin\u00e9mieBilan r\u00e9nalTSHADN (muqueuse jugale ou sang)Tissus (graisseux, h\u00e9patique)","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}