Actively Recruiting

Age: 50Years - 75Years
All Genders
ID04743479

Artificial Intelligence-based Early Screening and Diagnosis of Pancreatic Cancer Using Health Information Management System

Led by Changhai Hospital · Updated on 2023-09-01

5000

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Pancreatic cancer is a highly fatal disease with a low 5-year survival rate due to delayed diagnosis from vague symptoms. This research aims to identify risk factors and biomarkers for early pancreatic cancer detection to improve screening in high-risk individuals. The study focuses on groups including those with new-onset diabetes, familial pancreatic cancer, inherited syndromes, pancreatic cystic neoplasms, and chronic pancreatitis. It is a longitudinal observational study led by Dr. Jin Gang at Shanghai Changhai Hospital. Participants are grouped based on specific risk factors such as recent diabetes diagnosis, family history, or pancreatic conditions. They will undergo yearly questionnaires, laboratory tests, and high-resolution MRI or CT scans of the pancreas. Suspicious findings will be further examined using endoscopic ultrasound. Blood samples will be collected for DNA analysis. If cancer or precancerous lesions are found, surgical referral will be made. The study also collects clinical data and biological specimens for future related research. During the study, participants will have annual lab tests and imaging to monitor pancreatic health. Any suspicious lesions trigger additional specialized imaging. Researchers will track pancreatic cancer incidence and hazard ratios over five years, along with survival time and diagnostic yield. The study includes follow-up and data collection to understand early detection and outcomes. Participation duration and monitoring span up to five years, with data used to improve early diagnosis and treatment strategies for pancreatic cancer.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 50Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to provide informed consent
  • Willing to complete a detailed questionnaire
  • Diagnosed with new-onset diabetes within the past 3 years
  • Familial pancreatic cancer (multiple blood relatives affected or early diagnosis in 1st degree relative)
  • 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)
  • Pancreatic cystic neoplasm (including IPMN, MCN)
  • Chronic pancreatitis diagnosed by imaging, functional tests, or gastroenterologist
Not Eligible

You will not qualify if you...

  • Diagnosed with pancreatic cancer or other malignant tumors in the last 5 years
  • Any medical condition that contraindicates high-resolution MRI or CT
  • Unable to be followed up or currently participating in other clinical trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 5 years

Participants undergo annual laboratory tests and high-resolution MRI/CT examinations of the pancreas. If suspicious lesions are found, further examination by endoscopic ultrasound (EUS) is conducted.

Annual visits for laboratory tests and MRI/CT examinations; additional visits as needed for endoscopic ultrasound

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for pancreatic cancer incidence and related outcomes over 5 years. Blood samples are collected for DNA analysis and clinical data are recorded for future research.

Annual visits for ongoing assessments

Trial Site Locations

Total: 1 location

1

Shanghai Changhai Hospital

Shanghai, China, 200433

Actively Recruiting

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Research Team

B

Beilei Wang, M.D.

S

Shiwei Guo, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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Frequently Asked Questions

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Published Research Related To This Trial

Screening for Pancreatic Cancer: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Nora B Henrikson, Erin J Aiello Bowles, Paula R Blasi...

https://pubmed.ncbi.nlm.nih.gov/31386140

A Prospective Study to Establish a New-Onset Diabetes Cohort: From the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer.

Anirban Maitra, Ayush Sharma, Randall E Brand...

https://pubmed.ncbi.nlm.nih.gov/30325864