Artificial Intelligence-based Early Screening of Pancreatic Cancer and High Risk Tracing (ESPRIT-AI)

Sponsor
Changhai Hospital
Study ID
NCT04743479
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • high-resolution MRI/CT examinations — DIAGNOSTIC_TEST
    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).

Study Details

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. 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.

Key Dates

First listed
Feb 8, 2021
Start date
Dec 1, 2020
Status verified
Aug 2023
Primary completion
Dec 30, 2025
Completion
Dec 30, 2030

Study Design

Enrollment
5,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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
  • Arm: 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
  • Arm: 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.
  • Arm: Chronic pancreatitis
    Chronic pancreatitis, defined by cross-sectional imaging, endoscopic ultrasound, functional testing abnormalities OR as diagnosed by a gastroenterologist.

Primary Outcome Measure

Incidence [ Time Frame: 5 years ]

Central Contacts

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