[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100419573":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":39,"centralContacts":44,"locations":54,"responsibleParty":75,"collaborators":10,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":10,"studyType":92,"phases":10,"briefSummary":93,"conditions":94,"keywords":100,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Changhai Hospital","OTHER",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"New Onset Diabetes",null,"New Onset Diabetes must meet one of the following criteria:\n\n1. Documented diabetes diagnosed within the past 3 years.\n2. Definite new-onset diabetes based on recent fasting blood glucose (FBG) values ≥126 mg\u002Fdl (7.0 mmol\u002FL) or Hemoglobin A1c (HbA1c) ≥ 6.5%. All glycemic parameters must be measured in an outpatient setting.",[13],"Diagnostic Test: high-resolution MRI\u002FCT examinations",{"label":15,"type":10,"description":16,"interventionNames":17},"Familial pancreatic cancer","Familial pancreatic cancer must meet one of the following criteria:\n\n1. ≥ 2 blood relatives with pancreatic cancer (includes 1st-3rd degree relatives)\n2. One 1st degree relative with PDAC diagnosed before age 60",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Inherited syndromes associated with pancreatic cancer","Family history includes with inherited syndromes associated with pancreatic cancer ( ≥ 2 blood relative, includes 1st-3rd degree relatives).\n\nInherited syndromes must meet one of the following criteria:\n\n1. Hereditary pancreatitis\n2. Familial atypical multiple mole and melanoma syndrome\n3. Hereditary nonpolyposis colon cancer\n4. Peutz-Jeghers syndrome\n5. Hereditary breast and ovarian cancer syndromes",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Pancreatic Cystic Neoplasm","Pancreatic Cystic Neoplasm, including intraductal papillary mucinous neoplasms (IPMN) and mucinous cystic neoplasms (MCN), which are defined by endoscopic ultrasound or serial imaging.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Chronic pancreatitis","Chronic pancreatitis, defined by cross-sectional imaging, endoscopic ultrasound, functional testing abnormalities OR as diagnosed by a gastroenterologist.",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DIAGNOSTIC_TEST","high-resolution MRI\u002FCT examinations","Participants will undergo annual questionnaire survey, laboratory tests and high-resolution MRI\u002FCT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS).",[27,15,19,9,23],[37,38],"questionnaire survey","laboratory tests",[40],{"name":41,"affiliation":42,"role":43},"Gang Jin, M.D.","Department of general surgery, Changhai Hospital","STUDY_CHAIR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":10,"email":49},"Beilei Wang, M.D.","CONTACT","13774238083","lilly_wang@126.com",{"name":51,"role":47,"phone":52,"phoneExt":10,"email":53},"Shiwei Guo, M.D.","18621500666","gestwa@163.com",[55],{"facility":56,"status":57,"city":58,"state":10,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Shanghai Changhai Hospital","RECRUITING","Shanghai","200433","China","CN",{"type":63,"coordinates":64},"Point",[65,66],121.45806,31.22222,{"lat":66,"lon":65},[69,70,72],{"name":46,"role":47,"phone":48,"phoneExt":10,"email":49},{"name":41,"role":71,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":73,"role":74,"phone":10,"phoneExt":10,"email":10},"Bimeng Zhang, M.D.","SUB_INVESTIGATOR",{"type":71,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Guo ShiWei","Associated Professor at the Institute of Pancreatic Surgery","100419573","artificial-intelligence-based-early-screening-of-pancreatic-cancer-and-high-risk-tracing-esprit-ai-100419573",false,"NCT04743479","Artificial Intelligence-based Early Screening of Pancreatic Cancer and High Risk Tracing (ESPRIT-AI)","Artificial Intelligence-based Health Information Management System and Key Technology Study of Early Screening and Hierarchical Diagnosis and Treatment of Pancreatic Cancer","ESPRIT-AI","Inclusion Criteria:\n\n* Subject is able and willing to provide informed consent and sign an informed consent form.\n* Subject or authorized representative must be willing to complete a detailed questionnaire.\n* Subject must meet one of the following criteria:\n\n  1. New onset diabetes (diagnosed within the past 3 years)\n  2. Familial pancreatic cancer\n  3. Inherited syndromes associated with pancreatic cancer (including Hereditary pancreatitis, Familial atypical multiple mole and melanoma syndrome, Hereditary nonpolyposis colon cancer, Peutz-Jeghers syndrome, Hereditary breast and ovarian cancer syndromes, etc)\n  4. Pancreatic cystic neoplasm (including IPMN, MCN)\n  5. Chronic pancreatitis\n\nExclusion Criteria:\n\n* Subject has been diagnosed with pancreatic cancer or other malignant tumors in the last 5 years;\n* Subject has any medical condition that contraindicates high-resolution MRI or CT;\n* Subject cannot be followed up or is participating in other clinical trials.","ALL","50 Years","75 Years",{"count":90,"type":91},5000,"ESTIMATED","OBSERVATIONAL","Pancreatic cancer is one of the most fatal malignancies with a 5-year survival rate of only \\~6%\\[1\\]. The reasons for this high mortality rate can be attributed to several factors, of which perhaps the most important is delayed diagnosis due to vague symptoms and consequently missed opportunities for surgical resection. Therefore, the ability to detect pancreatic cancer at an early, more curable stage is urgently needed.\n\nIdentifying risk factors and biomarkers of early pancreatic cancer could facilitate screening for individuals at higher than average risk and expedite the diagnosis in individuals with symptoms and substantially improve an individual's chance of surviving the disease. Thus, the investigators propose this longitudinal study entitled, \"Artificial Intelligence-based Early Screening of Pancreatic Cancer and High Risk Tracing (ESPRIT-AI)\" in order to generate clinical data sets and bank serial blood specimens of high risk individuals.",[95,96,97,23,98,99],"Pancreatic Cancer","Diabetes","Familial Pancreatic Cancer","Chronic Pancreatitis","Hereditary Pancreatitis",[101,102,103,95],"Screening","Early Diagnosis","Artificial Intelligence","2023-08-31",{"date":106,"type":107},"2023-09-01","ACTUAL",{"date":109,"type":107},"2020-12-01",{"date":111,"type":91},"2030-12-30",{"name":5,"class":6},1]