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

August 31, 2023 updated by: Guo ShiWei, Changhai Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Shiwei Guo, M.D.
  • Phone Number: 18621500666
  • Email: gestwa@163.com

Study Locations

  • China
      • Shanghai, China, 200433
        • Recruiting
        • Shanghai Changhai Hospital
        • Contact:
        • Sub-Investigator:
          • Bimeng Zhang, M.D.
        • Principal Investigator:
          • Gang Jin, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

High risk individuals of pancreatic cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: 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 Names:
  • questionnaire survey
  • laboratory tests
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
Diagnostic test: 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 Names:
  • questionnaire survey
  • laboratory tests
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
Diagnostic test: 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 Names:
  • questionnaire survey
  • laboratory tests
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.
Diagnostic test: 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 Names:
  • questionnaire survey
  • laboratory tests
Chronic pancreatitis
Chronic pancreatitis, defined by cross-sectional imaging, endoscopic ultrasound, functional testing abnormalities OR as diagnosed by a gastroenterologist.
Diagnostic test: 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 Names:
  • questionnaire survey
  • laboratory tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence
Time Frame: 5 years
Determine incidence of pancreatic cancer or precursor lesions among high risk individuals.
5 years
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival time
Time Frame: 5 years
Calculate survival time from point of diagnosis and treatment among the identified patients with pancreatic cancer.
5 years
HR
Time Frame: 5 years
Assesses the influence of risk factors on survival time among the identified patients with pancreatic cancer.
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Study Chair: Gang Jin, M.D., Department of general surgery, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2030

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChanghaiH-PP07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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