{"doc_desc":{"title":"Cohorte nationale des tumeurs intracanalaires papillaires mucineuses du pancr\u00e9as des canaux secondaires","idno":"FRESH-PEF8883-fr","producers":[{"name":"Vinciane REBOURS","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8883-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8883"},{"agency":"FReSH","code":"FRESH-PEF8883"}]},"title":"Cohorte nationale des tumeurs intracanalaires papillaires mucineuses du pancr\u00e9as des canaux secondaires","alternate_title":"TEAM-P"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Vinciane;REBOURS","PILabo":"AP-HP (Paris Public Hospitals) \/ Pancreatology Department, Beaujon Hospital","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"081338473","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"vinciane.rebours@aphp.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ASSOCIATION NATIONALE DES HEPATO-GASTROENTEROLOGUES DES HOPITAUX GENERAUX DE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0269vww35","role":"sponsor id"}],"role":"sponsor"},{"name":"CLUB REFLEXION GROUPES DE GASTRO ENTEROL (CREGG)","extlink":[{"title":"SIREN","uri":"342104460","role":"sponsor id"}],"role":"sponsor"},{"name":"SOCIETE FRANCAISE D'ENDOSCOPIE DIGESTIVE (SFED)","extlink":[{"title":"SIREN","uri":"318412954","role":"sponsor id"}],"role":"sponsor"},{"name":"CLUB FRANCOPHONE D ECHOENDOSCOPIE (ASSOCIATION)","extlink":[{"title":"SIREN","uri":"502472665","role":"sponsor id"}],"role":"sponsor"},{"name":"SOCIETE NATIONALE FRAN\u00c7AISE DE GASTRO-ENTEROLOGIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04c6sc363","role":"sponsor id"}],"role":"sponsor"},{"name":"","extlink":[],"role":"sponsor"}],"funding_agencies":[{"name":"SOCIETE NATIONALE FRAN\u00c7AISE DE GASTRO-ENTEROLOGIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04c6sc363"}]}]},"distribution_statement":{"contact":[{"name":"Vinciane;REBOURS","email":"vinciane.rebours@aphp.fr","type":"contact","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":"Tumeurs intracanalaires papillaires mucineuses du pancr\u00e9as"},{"keyword":"TIPMP"}],"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":"Gastroent\u00e9rologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/a3898340-a42d-4f5e-a822-1de204a9a867"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005762"}]}],"purpose":"Effectuer un suivi prospectif standardis\u00e9 au long cours (sup\u00e9rieur \u00e0 5 ans) de patients pr\u00e9sentant une TIPMP des canaux secondaires sans atteinte du canal principal et sans crit\u00e8res de d\u00e9g\u00e9n\u00e9rescence. Les objectifs sont de d\u00e9terminer: - le risque de d\u00e9g\u00e9n\u00e9rescence \u00e0 long terme (objectif principal) - les crit\u00e8res morphologiques pr\u00e9dictifs de d\u00e9g\u00e9n\u00e9rescence (objectif secondaire) - les sous-groupes de patients \u00e0 risque de d\u00e9g\u00e9n\u00e9rescence en fonction de leurs caract\u00e9ristiques sociod\u00e9mographiques, cliniques, morphologiques et mol\u00e9culaires (objectif secondaire).","abstract":"","coll_dates":[{"start":"2012-01-01"}],"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            \"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\": \" TIPMP d\u00e9velopp\u00e9e uniquement aux d\u00e9pends des canaux secondaires - Absence de signes de transformation maligne des l\u00e9sions de TIPMP - Canal pancr\u00e9atique principal de diam\u00e8tre inf\u00e9rieur ou \u00e9gal \u00e0 6mm - En cas de patients aux ant\u00e9c\u00e9dents d'ex\u00e9r\u00e8se chirurgicale de TIPMP, pr\u00e9sence de l\u00e9sion(s) r\u00e9siduelle(s) de TIPMP des canaux secondaires  Tout patient pr\u00e9sentant une TIPMP des canaux secondaires d\u00e9couverte avant la mise en place de l'\u00e9tude TEAM-P peut \u00eatre inclus.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques']","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"}]},"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":"[1000-10000[ individus","response_rate":"1500"},"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":"Contacter le responsable scientifique","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":"12-05-2014","lastUpdatedAuto":null,"lastUpdatedManual":"03-07-2016","isContributorPI":"Non","contributorName":"Vinciane REBOURS","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":["","","","","",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"A l\u2019inclusion des patients, une fiche d\u00e9taillant les caract\u00e9ristiques sociod\u00e9mographiques et cliniques des patients sera remplie par le praticien sur le site internet d\u00e9di\u00e9. CRF \u00e9lectronique.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Suivi morphologique selon un protocole de surveillance unique standardis\u00e9 pour tous les patients","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}