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

Diabetes Clinical Trial

— ESPRIT-AI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04743479
• Other study ID #: ChanghaiH-PP07
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: December 30, 2030

Study information

• Verified date: August 2023
• Source: Changhai Hospital
• Contact: Beilei Wang, M.D.
• Phone: 13774238083
• Email: lilly_wang[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 30, 2030
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Diabetes
• Familial Pancreatic Cancer
• Hereditary Pancreatitis
• Neoplasms, Cystic, Mucinous, and Serous
• Pancreatic Cancer
• Pancreatic Cystic Neoplasm
• Pancreatic Neoplasms
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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).

Locations

Country	Name	City	State
China	Shanghai Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence	Determine incidence of pancreatic cancer or precursor lesions among high risk individuals.	5 years
Primary	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	Survival time	Calculate survival time from point of diagnosis and treatment among the identified patients with pancreatic cancer.	5 years
Secondary	HR	Assesses the influence of risk factors on survival time among the identified patients with pancreatic cancer.	5 years
Secondary	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