Artificial Intelligence-based Early Screening of Pancreatic Cancer and High Risk Tracing (ESPRIT-AI)
NCT ID: NCT04743479
Last Updated: 2023-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2020-12-01
2030-12-30
Brief Summary
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Identifying 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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New Onset Diabetes
New Onset Diabetes must meet one of the following criteria:
1. Documented diabetes diagnosed within the past 3 years.
2. Definite new-onset diabetes based on recent fasting blood glucose (FBG) values ≥126 mg/dl (7.0 mmol/L) or Hemoglobin A1c (HbA1c) ≥ 6.5%. All glycemic parameters must be measured in an outpatient setting.
high-resolution MRI/CT examinations
Participants will undergo annual questionnaire survey, laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS).
Familial pancreatic cancer
Familial pancreatic cancer must meet one of the following criteria:
1. ≥ 2 blood relatives with pancreatic cancer (includes 1st-3rd degree relatives)
2. One 1st degree relative with PDAC diagnosed before age 60
high-resolution MRI/CT examinations
Participants will undergo annual questionnaire survey, laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS).
Inherited syndromes associated with pancreatic cancer
Family history includes with inherited syndromes associated with pancreatic cancer ( ≥ 2 blood relative, includes 1st-3rd degree relatives).
Inherited syndromes must meet one of the following criteria:
1. Hereditary pancreatitis
2. Familial atypical multiple mole and melanoma syndrome
3. Hereditary nonpolyposis colon cancer
4. Peutz-Jeghers syndrome
5. Hereditary breast and ovarian cancer syndromes
high-resolution MRI/CT examinations
Participants will undergo annual questionnaire survey, laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS).
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.
high-resolution MRI/CT examinations
Participants will undergo annual questionnaire survey, laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS).
Chronic pancreatitis
Chronic pancreatitis, defined by cross-sectional imaging, endoscopic ultrasound, functional testing abnormalities OR as diagnosed by a gastroenterologist.
high-resolution MRI/CT examinations
Participants will undergo annual questionnaire survey, laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS).
Interventions
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high-resolution MRI/CT examinations
Participants will undergo annual questionnaire survey, laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject or authorized representative must be willing to complete a detailed questionnaire.
* Subject must meet one of the following criteria:
1. New onset diabetes (diagnosed within the past 3 years)
2. Familial pancreatic cancer
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)
4. Pancreatic cystic neoplasm (including IPMN, MCN)
5. Chronic pancreatitis
Exclusion Criteria
* Subject has any medical condition that contraindicates high-resolution MRI or CT;
* Subject cannot be followed up or is participating in other clinical trials.
50 Years
75 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Guo ShiWei
Associated Professor at the Institute of Pancreatic Surgery
Principal Investigators
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Gang Jin, M.D.
Role: STUDY_CHAIR
Department of general surgery, Changhai Hospital
Locations
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Shanghai Changhai Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Kamisawa T, Wood LD, Itoi T, Takaori K. Pancreatic cancer. Lancet. 2016 Jul 2;388(10039):73-85. doi: 10.1016/S0140-6736(16)00141-0. Epub 2016 Jan 30.
Lin QJ, Yang F, Jin C, Fu DL. Current status and progress of pancreatic cancer in China. World J Gastroenterol. 2015 Jul 14;21(26):7988-8003. doi: 10.3748/wjg.v21.i26.7988.
Henrikson NB, Aiello Bowles EJ, Blasi PR, Morrison CC, Nguyen M, Pillarisetty VG, Lin JS. Screening for Pancreatic Cancer: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2019 Aug 6;322(5):445-454. doi: 10.1001/jama.2019.6190.
Singhi AD, Koay EJ, Chari ST, Maitra A. Early Detection of Pancreatic Cancer: Opportunities and Challenges. Gastroenterology. 2019 May;156(7):2024-2040. doi: 10.1053/j.gastro.2019.01.259. Epub 2019 Feb 2.
Pereira SP, Oldfield L, Ney A, Hart PA, Keane MG, Pandol SJ, Li D, Greenhalf W, Jeon CY, Koay EJ, Almario CV, Halloran C, Lennon AM, Costello E. Early detection of pancreatic cancer. Lancet Gastroenterol Hepatol. 2020 Jul;5(7):698-710. doi: 10.1016/S2468-1253(19)30416-9. Epub 2020 Mar 2.
Maitra A, Sharma A, Brand RE, Van Den Eeden SK, Fisher WE, Hart PA, Hughes SJ, Mather KJ, Pandol SJ, Park WG, Feng Z, Serrano J, Rinaudo JAS, Srivastava S, Chari ST; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). A Prospective Study to Establish a New-Onset Diabetes Cohort: From the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer. Pancreas. 2018 Nov/Dec;47(10):1244-1248. doi: 10.1097/MPA.0000000000001169.
Other Identifiers
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ChanghaiH-PP07
Identifier Type: -
Identifier Source: org_study_id
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