Artificial Intelligence-based Early Screening Of Pancreatic Cancer And High Risk Tracing (ESPRIT-AI)

Study Overview

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, Ȫrtificial 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.

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.

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

DIAGNOSTIC_TEST: high-resolution MRI/CT examinations

ChanghaiH-PP07

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-02-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-08-31
First Submitted that Met QC Criteria 2021-02-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-09-01
First Posted (ACTUAL) 2021-02-08	Results First Posted N/A	Last Verified 2023-08

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	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.	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).
: 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).
: 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 mul	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).
: 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).
: 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).

Primary Outcome Measures	Measure Description	Time Frame
Incidence	Determine incidence of pancreatic cancer or precursor lesions among high risk individuals.	5 years
Hazard ratio (HR)	Assesses the influence of risk factors on the incidence of pancreatic cancer or precursor lesions among high risk individuals.	5 years

Secondary Outcome Measures	Measure Description	Time Frame
Survival time	Calculate survival time from point of diagnosis and treatment among the identified patients with pancreatic cancer.	5 years
HR	Assesses the influence of risk factors on survival time among the identified patients with pancreatic cancer.	5 years
Diagnostic yield	Determine diagnostic yield (sensitivity, specificity, positive/negative predictive value and accuracy) of AI-based surveillance program to predict early stage pancreatic cancer.	5 years

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

Name: Beilei Wang, M.D.

Phone Number: 13774238083

Email: lilly_wang@126.com

Study Contact Backup

Name: Shiwei Guo, M.D.

Phone Number: 18621500666

Email: gestwa@163.com

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
50 Years

Accepts Healthy Volunteers:

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:

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.

Collaborators and Investigators

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

Investigators

STUDY_CHAIR: Gang Jin, M.D., Department of general surgery, Changhai Hospital

Publications

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

General Publications

Kamisawa T, Wood LD, Itoi T, Takaori K. Pancreatic cancer. Lancet. 2016 Jul 2;388(10039):73-85. doi: 10.1016/S0140-6736(16)00141-0. Epub 2016 Jan 30.
Lin QJ, Yang F, Jin C, Fu DL. Current status and progress of pancreatic cancer in China. World J Gastroenterol. 2015 Jul 14;21(26):7988-8003. doi: 10.3748/wjg.v21.i26.7988.
Henrikson NB, Aiello Bowles EJ, Blasi PR, Morrison CC, Nguyen M, Pillarisetty VG, Lin JS. Screening for Pancreatic Cancer: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2019 Aug 6;322(5):445-454. doi: 10.1001/jama.2019.6190.
Singhi AD, Koay EJ, Chari ST, Maitra A. Early Detection of Pancreatic Cancer: Opportunities and Challenges. Gastroenterology. 2019 May;156(7):2024-2040. doi: 10.1053/j.gastro.2019.01.259. Epub 2019 Feb 2.
Pereira SP, Oldfield L, Ney A, Hart PA, Keane MG, Pandol SJ, Li D, Greenhalf W, Jeon CY, Koay EJ, Almario CV, Halloran C, Lennon AM, Costello E. Early detection of pancreatic cancer. Lancet Gastroenterol Hepatol. 2020 Jul;5(7):698-710. doi: 10.1016/S2468-1253(19)30416-9. Epub 2020 Mar 2.
Maitra A, Sharma A, Brand RE, Van Den Eeden SK, Fisher WE, Hart PA, Hughes SJ, Mather KJ, Pandol SJ, Park WG, Feng Z, Serrano J, Rinaudo JAS, Srivastava S, Chari ST; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). A Prospective Study to Establish a New-Onset Diabetes Cohort: From the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer. Pancreas. 2018 Nov/Dec;47(10):1244-1248. doi: 10.1097/MPA.0000000000001169.

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