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NCT Number: NCT04743479

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

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.

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Key information

About this study

The study is being run by a team of dedicated physicians and researchers, led by Jin Gang, MD, Director of Department of general surgery of Shanghai Changhai Hospital. The trial will include individuals with new-onset diabetes (diagnosed within the past 3 year), familial pancreatic cancer, 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), pancreatic cystic neoplasm (including IPMN, MCN) as well as chronic pancreatitis. Participants will undergo annual laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS). If pancreatic cancer or a pre-cancerous lesion is identified, the individual will be referred for surgery. We will also be collecting a blood sample from all participants for DNA isolation. Clinical data and biological specimens contained in this study may be used for a wide variety of future related studies to the cause, diagnosis, outcome and treatment of pancreatic cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • New onset diabetes (diagnosed within the past 3 years)
  • Familial pancreatic cancer
  • 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)
  • Pancreatic cystic neoplasm (including IPMN, MCN)
  • 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.

Treatment and study plan

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).

Other names: questionnaire survey, laboratory tests

Primary outcomes

  1. Incidence

    Time frame: 5 years

    Determine incidence of pancreatic cancer or precursor lesions among high risk individuals.

  2. Hazard ratio (HR)

    Time frame: 5 years

    Assesses the influence of risk factors on the incidence of pancreatic cancer or precursor lesions among high risk individuals.

Secondary outcomes

  1. Survival time

    Time frame: 5 years

    Calculate survival time from point of diagnosis and treatment among the identified patients with pancreatic cancer.

  2. HR

    Time frame: 5 years

    Assesses the influence of risk factors on survival time among the identified patients with pancreatic cancer.

  3. Diagnostic yield

    Time frame: 5 years

    Determine diagnostic yield (sensitivity, specificity, positive/negative predictive value and accuracy) of AI-based surveillance program to predict early stage pancreatic cancer.

Study contacts

Contact information is provided by the study sponsor or research team.

Beilei Wang, M.D.

CONTACT

[email protected]

13774238083

Shiwei Guo, M.D.

CONTACT

[email protected]

18621500666

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Artificial Intelligence-based Health Information Management System and Key Technology Study of Early Screening and Hierarchical Diagnosis and Treatment of Pancreatic Cancer

Acronym: ESPRIT-AI

Important dates

Study start
2020
Primary completion
2025
Study completion
2030
First posted
Feb 8, 2021
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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