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Clinical Trials in China / NCT04743479
Recruiting Observational

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

NCT04743479 · tracked via the Priya Life Science China tracker
Sponsor
Changhai Hospital
Phase
Observational
Started
2020-12-01
Last updated
2023-09-01

Condition(s) studied

Pancreatic CancerDiabetesFamilial Pancreatic CancerPancreatic Cystic NeoplasmChronic PancreatitisHereditary Pancreatitis

Investigational drug(s) / intervention(s)

high-resolution MRI/CT examinations

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).

Study summary

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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Subject is able and willing to provide informed consent and sign an informed consent form. * 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 been diagnosed with pancreatic cancer or other malignant tumors in the last 5 years; * Subject has any medical condition that contraindicates high-resolution MRI or CT; * Subject cannot be followed up or is participating in other clinical trials.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Changhai Hospital Shanghai China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04743479 on ClinicalTrials.gov ↗ ← All trials in China