{"doc_desc":{"title":"National Cohort of Secondary-Duct Intraductal Papillary Mucinous Neoplasms of the Pancreas","idno":"FRESH-PEF8883-en","producers":[{"name":"Vinciane REBOURS","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8883-en","IDno":{"metadata_no":[{"agency":"PEF","code":"8883"},{"agency":"FReSH","code":"FRESH-PEF8883"}]},"title":"National Cohort of Secondary-Duct Intraductal Papillary Mucinous Neoplasms of the Pancreas","alternate_title":"TEAM-P"},"study_authorization":{"agency":[]},"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":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"intraductal papillary mucinous tumours of the pancreas"},{"keyword":"IPMN"}],"topics":[{"topic":"Endocrinology","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":"Gastroenterology","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":"To carry out a long-term standardised prospective study (over 5 years) of patients with IPMN in the secondary ducts that have not reached the main duct with no onset of deterioration. The aims are to determine: \u2013 The risk of deterioration in the long term (main objective); \u2013 Morphological factors predicting deterioration (secondary aim) \u2013 Subgroups of patients at risk of deterioration based on their sociodemographic, clinical, morphological and molecular characteristics (secondary aim).","abstract":"","coll_dates":[{"start":"2012-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"\u2013 IPMN only in the secondary ducts;  \u2013 No signs of malignant transformation of IPMN lesions;  \u2013 Main pancreatic duct no more than 6 mm in diameter;  \u2013 Presence of residual IPMN lesions in the secondary ducts for patients with a history of IPMN surgical resection.  All patients with diagnosed secondary-duct IPMN before TEAM-P study was begun may be included.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1,500"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"12-05-2014","lastUpdatedAuto":null,"lastUpdatedManual":"03-07-2016","isContributorPI":"No","contributorName":"Vinciane REBOURS","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Private non-profit"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Private non-profit","Private non-profit","Private non-profit","Private non-profit","Private non-profit","Private non-profit"],"otherSponsorType":["","","","","",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"A file containing the sociodemographic and clinical characteristics of the patients will be completed at baseline by the physician on the dedicated website.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Morphological follow-up according to a unique standardised monitoring protocol for all patients.","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}