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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04743479
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Guo ShiWei, Changhai Hospital

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
Pancreatic Cancer Diabetes Familial Pancreatic Cancer Pancreatic Cystic Neoplasm Chronic Pancreatitis Hereditary Pancreatitis 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.

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Study Type : Observational
Estimated 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 : December 1, 2020
Estimated Primary Completion Date : December 30, 2025
Estimated Study Completion Date : December 30, 2030


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Patients in this study will have the option of donating blood for biobanking, approximately 10cc of plasma and 10cc of serum. Further, samples that are routinely collected for diagnostic purposes may be collected and banked at the time of their clinically routine procedure. If a patient consents to the use of extra material for research purposes, the biological samples will be banked and the blood, and/or pancreatic juice/cystic fluid, tissues, and saliva will be used for identification and characterization of potential biomarkers from de-identified samples.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
High risk individuals of pancreatic cancer
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743479


Contacts
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Contact: Beilei Wang, M.D. 13774238083 lilly_wang@126.com
Contact: Shiwei Guo, M.D. 18621500666 gestwa@163.com

Locations
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China
Shanghai Changhai Hospital Recruiting
Shanghai, China, 200433
Contact: Beilei Wang, M.D.    13774238083    lilly_wang@126.com   
Principal Investigator: Gang Jin, M.D.         
Sub-Investigator: Bimeng Zhang, M.D.         
Sponsors and Collaborators
Changhai Hospital
Investigators
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Study Chair: Gang Jin, M.D. Department of general surgery, Changhai Hospital
Publications:

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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: February 8, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guo ShiWei, Changhai Hospital:
Screening
Early Diagnosis
Artificial Intelligence
Pancreatic Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Pancreatitis
Pancreatitis, Chronic
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases