{"doc_desc":{"title":"RaDiCo-COLPAC - Cohorte nationale sur l\u2019\u00e9pid\u00e9miologie, l\u2019h\u00e9t\u00e9rog\u00e9n\u00e9it\u00e9 clinique et g\u00e9n\u00e9tique du syndrome \u00ab Low Phospholipid\u2010Associated Cholelithiasis \u00bb (LPAC)","idno":"FRESH-PEF74147-fr","producers":[{"name":"Sonia GUEGUEN","affiliation":"SORBONNE UNIVERSITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74147-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74147"},{"agency":"FReSH","code":"FRESH-PEF74147"}]},"title":"RaDiCo-COLPAC - Cohorte nationale sur l\u2019\u00e9pid\u00e9miologie, l\u2019h\u00e9t\u00e9rog\u00e9n\u00e9it\u00e9 clinique et g\u00e9n\u00e9tique du syndrome \u00ab Low Phospholipid\u2010Associated Cholelithiasis \u00bb (LPAC)","alternate_title":"RaDiCo-COLPAC"},"study_authorization":{"agency":[{"name":"CPP"},{"name":"CESREES"}]},"authoring_entity":[{"type":"investigator","name":"Christophe;CORPECHOT","PILabo":"Institut National de la Sant\u00e9 et de la Recherche M\u00e9dicale (Inserm) \/ UMR_S938","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"231498276","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"200918542V","role":"labo id"}],"email":"","isContact":"Non"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[],"topics":[{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"H\u00e9patologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/27c456a1-051a-42f6-b52a-3beff0487da7"}]},{"topic":"Chol\u00e9lithiase","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1268183934","title":"CIM-11"}]}],"purpose":"L\u2019objectif principal est de d\u00e9crire les diff\u00e9rentes manifestations cliniques, biologiques et radiologiques du syndrome LPAC d\u00e9fini selon les crit\u00e8res diagnostiques actuels ou selon des crit\u00e8res \u00e9tendus \u00e0 toute maladie lithiasique biliaire symptomatique r\u00e9cidivante et d\u2019en d\u00e9limiter les diff\u00e9rentes \u00e9volutions possibles.","abstract":"","coll_dates":[{"start":"2017-01-01","end":"2028-01-01"}],"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\": \"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            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Crit\u00e8re d'inclusion :  Tout patient de plus de 13 ans, pr\u00e9valent ou incident, r\u00e9pondant aux crit\u00e8res diagnostiques usuels (Cat\u00e9gorie de patients 1 : lithiase biliaire symptomatique avec au moins 2 crit\u00e8res de syndrome LPAC sur 3, voir ci-dessous) ou \u00e9tendus (Cat\u00e9gorie de patients 2 : lithiase biliaire symptomatique avec un seul crit\u00e8re de syndrome LPAC sur 3, voir ci-dessous) du syndrome LPAC.  Crit\u00e8res diagnostiques du syndrome LPAC (patients symptomatiques) : 1)Premiers sympt\u00f4mes avant l\u2019\u00e2ge de 40 ans 2)Images radiologiques compatibles avec l\u2019existence d\u2019une lithiase intra-h\u00e9patique (calculs, sludge, foyers hyper-\u00e9chog\u00e8nes, \u00ab queues de com\u00e8tes \u00bb) 3)R\u00e9cidive des sympt\u00f4mes apr\u00e8s chol\u00e9cystectomie    \",\n    \"clusion_E\": \"Patients ayant subi une transplantation h\u00e9patique\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Plan de Data Management et Plan de Validation des Donn\u00e9es. Management des donn\u00e9es en continu (r\u00e8gles de contr\u00f4le automatiques et syst\u00e8me de \"queries\")']"}},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}","{\"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":"550 \u00e0 650 patients estim\u00e9s"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Registre de morbidit\u00e9"]}]},"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 demandes d'acc\u00e8s aux donn\u00e9es RaDiCo-COLPAC (agr\u00e9g\u00e9es ou individuelles) seront examin\u00e9es par le Comit\u00e9 Scientifique suite \u00e0 la soumission d'un r\u00e9sum\u00e9 de Projet de Recherche Sp\u00e9cifique (PRS), tel que d\u00e9fini dans la Charte d'acc\u00e8s aux ressources.","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":"21-02-2024","lastUpdatedAuto":null,"lastUpdatedManual":"03-12-2024","isContributorPI":"Non","contributorName":"Sonia GUEGUEN","contributorAffiliation":"SORBONNE UNIVERSITE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":"Oui"},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"eCRF en acc\u00e8s s\u00e9curis\u00e9 web, cloud s\u00e9curis\u00e9 et h\u00e9bergement HADS","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Donn\u00e9es d\u00e9mographiques, caract\u00e9ristiques au diagnostic, ant\u00e9c\u00e9dents m\u00e9dicaux li\u00e9s \u00e0 la pathologie, comorbidit\u00e9s non li\u00e9es \u00e0 la pathologie, ant\u00e9c\u00e9dents familiaux, sympt\u00f4mes, traitements sp\u00e9cifiques LPAC et autres, interventions chirurgicales ou endoscopiques, ....","biologicalDataDetails":"R\u00e9sultats h\u00e9matologiques (NFS) et biochimiques, analyses biliaires, ....","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}