{"doc_desc":{"title":"Cohorte de patients en attente de greffe pulmonaire ou cardio-pulmonaire","idno":"FRESH-PEF60154-fr","producers":[{"name":"Antoine MAGNAN","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60154-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60154"},{"agency":"FReSH","code":"FRESH-PEF60154"}]},"title":"Cohorte de patients en attente de greffe pulmonaire ou cardio-pulmonaire","alternate_title":"COLT : Cohort in lung transplantation"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Antoine;MAGNAN","PILabo":"INSERM \/ CHU DE \/ Institut du Thorax UMR 1087","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"075645300","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"201220396X","role":"labo id"}],"email":"a.magnan@hopital-foch.com","isContact":"Oui"}],"oth_id":[{"name":"Participation au projet Europ\u00e9en SysCLAD Participation au r\u00e9seau Europ\u00e9en ENCE LTx CF LM","type":"collaboration"}],"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":"AGENCE DE LA BIOMEDECINE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03tajza86"},{"title":"SIREN","uri":"180092587"}]},{"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":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"VAINCRE LA MUCOVISCIDOSE (AFLM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00gp9bw49"},{"title":"SIREN","uri":"784287583"}]}]},"distribution_statement":{"contact":[{"name":"Antoine;MAGNAN","email":"a.magnan@hopital-foch.com","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"}]},{"name":"Aurore;FOUREAU","email":"aurore.foureau@chu-nantes.fr","type":"contact","affiliationName":"NANTES UNIVERSITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/03gnr7b55","role":"organisation id","title":"ROR"},{"uri":"130029747","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"transplantation pulmonaire"},{"keyword":"dysfonction chronique du greffon"},{"keyword":"biomarqueurs"}],"topics":[{"topic":"Pneumologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D015272"}]},{"topic":"Pr\u00e9sence d\u2019un poumon transplant\u00e9","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/845079170","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 : mettre en \u00e9vidence des marqueurs pr\u00e9dictifs de la survenue du rejet chronique de greffe pulmonaire par des approches d'immunologie, de transcriptomique, de g\u00e9nomique, de prot\u00e9ome appliqu\u00e9es au pr\u00e9l\u00e8vements sanguins et in situ r\u00e9alis\u00e9s sur les patients de la cohorte.","abstract":"","coll_dates":[{"start":"2009-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Belgique","abbreviation":"be","extLink":{"vocab":"ISO","vocabURI":"be"}}],"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\": \"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Hommes et femmes \u00e2g\u00e9s de plus de 18 ans, sur liste d'attente de greffe pulmonaire ou cardio-pulmonaire, ou inclus au moment de la transplantation, ayant donn\u00e9 leur consentement \u00e9crit.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","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 : Retour au dossier source Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi ? Oui Relance des sujets pour r\u00e9aliser les visites de suivi ? Oui R\u00e9alisation d\\'audit qualit\u00e9 : Audits internes Fr\u00e9quence audit interne : 1 FOIS PAR AN Autre(s) proc\u00e9dure(s) qualit\u00e9 : Proc\u00e9dures qualit\u00e9 CIC (Centre d\\'Investigation Cliniques) Thorax de Nantes Proc\u00e9dures qualit\u00e9 CRB (Centre de Ressources Biologiques) Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es (Ecrite)']"}},"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"}]},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1870 included patient, 1560 transplanted patients followed up"},"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 via approbation du conseil scientifique de la cohorte. Utilisation possible des donn\u00e9es par des industriels via approbation du comit\u00e9 directeur de la cohorte","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"08-11-2018","isContributorPI":"Non","contributorName":"Antoine MAGNAN","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=COLT+AND+Magnan+A[author]"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"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":"Saisie manuelle des informations recueillies durant l'entretient \u00e0 partir de questionnaires papiers, avec double saisie Examens cliniques : saisie directe Examens biologiques : saisie directe","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique impliquant les 11 centres de transplantation fran\u00e7ais et le centre d'Erasme \u00e0 Bruxelles (Belgique)."},"dataTypes":{"clinicalDataDetails":"Examen clinique au cours du suivi pr\u00e9-transplantation et post-transplantation tous les ans Informations recueillies : ant\u00e9c\u00e9dents, traitements concomitants, colonisation bact\u00e9rienne et virale, \u00e9pisodes de rejets, infections, fonction respiratoire, complication de la transplantation, immunologie, survie","biologicalDataDetails":"Pour les 1200 premiers patients transplant\u00e9s suivis: \u00e0 chaque visite, une prise de sang veineux pour l\u2019analyse des populations lymphocytaires, du g\u00e9nome et du transcriptome seront syst\u00e9matiquement r\u00e9alis\u00e9es. Selon les possibilit\u00e9s et les pratiques de chaque centre, une expectoration induite (EI) ainsi qu\u2019un pr\u00e9l\u00e8vement de condensat de l\u2019air exhal\u00e9 (CAE) seront r\u00e9alis\u00e9s. Un pr\u00e9l\u00e8vement de liquide broncho-alv\u00e9olaire (LBA), et\/ou 2 biopsies trans-bronchiques seront obtenus selon les habitudes de chaque centre","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}