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

Sponsor
Changhai Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04743479
Collaborator
(none)
5,000
1
120.9
41.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: high-resolution MRI/CT examinations

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 Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Artificial Intelligence-based Health Information Management System and Key Technology Study of Early Screening and Hierarchical Diagnosis and Treatment of Pancreatic Cancer
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 30, 2025
Anticipated Study Completion Date :
Dec 30, 2030

Arms and Interventions

Arm Intervention/Treatment
New Onset Diabetes

New Onset Diabetes must meet one of the following criteria: Documented diabetes diagnosed within the past 3 years. 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: ≥ 2 blood relatives with pancreatic cancer (includes 1st-3rd degree relatives) 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: Hereditary pancreatitis Familial atypical multiple mole and melanoma syndrome Hereditary nonpolyposis colon cancer Peutz-Jeghers syndrome 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
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence [5 years]

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

    2. Hazard ratio (HR) [5 years]

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

    Secondary Outcome Measures

    1. Survival time [5 years]

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

    2. HR [5 years]

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

    3. Diagnostic yield [5 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Changhai Hospital Shanghai China 200433

    Sponsors and Collaborators

    • Changhai Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Guo ShiWei, Associated Professor at the Institute of Pancreatic Surgery, Changhai Hospital
    ClinicalTrials.gov Identifier:
    NCT04743479
    Other Study ID Numbers:
    • ChanghaiH-PP07
    First Posted:
    Feb 8, 2021
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guo ShiWei, Associated Professor at the Institute of Pancreatic Surgery, Changhai Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 9, 2022