Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06041009

Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations: A Multicenter, Prospective, Diagnostic Clinical Cohort Study

Led by Qilu Hospital of Shandong University · Updated on 2024-10-18

2100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

Q

Qilu Hospital of Shandong University

Lead Sponsor

F

First Affiliated Hospital, Sun Yat-Sen University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a prospective cohort study to develop a diagnostic prediction model for pancreatic ductal adenocarcinoma (PDAC) and other pancreatic diseases. The study enrolls patients with PDAC, individuals at high risk for PDAC, patients with other pancreatic tumors or elevated CA19-9 levels, and control participants without pancreatic disease. The goal is to improve early diagnosis, especially for resectable PDAC, by combining elastase 1 detection with other clinical and imaging tests, including endoscopic ultrasonography (EUS). Participants undergo serum sample collection to measure pancreatic elastase-1 and multi-omics analyses. For patients undergoing surgery or necessary biopsy, pancreatic tissue samples are also collected. The study uses various diagnostic examinations such as clinical serological tests and imaging to evaluate and validate the diagnostic model in different participant groups, including patients with pancreatic neuroendocrine tumors, solid pseudopapillary tumors, and those with elevated CA19-9. During the study, participants will be monitored over two years to assess the diagnostic value of the model, including sensitivity, specificity, accuracy, and predictive values. Researchers will also measure the elastase 1 content and explore new biomarkers from serum and pancreatic tissues. The study includes detailed laboratory tests, imaging, and multi-omics analyses to improve diagnosis, with regular assessments to track progress and results throughout the study period.

CONDITIONS

Brief Title

Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with pancreatic cancer according to recognized criteria
  • Patients at high risk for pancreatic cancer
  • Patients diagnosed with solid pseudopapillary tumors or neuroendocrine tumors of the pancreas
  • Patients with other diseases showing abnormally elevated CA19-9 levels
  • Control patients without pancreatic disease and no CA19-9 elevation based on lab and imaging tests
  • Participants aged 18 years or older
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years
  • Patients suspected of pancreatic malignant lesions without confirmed imaging or pathological diagnosis
  • Patients who have not signed informed consent

AI-Screening

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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 2 years

Participants undergo blood serum sampling and other examinations to detect pancreatic elastase-1 and assess pancreatic health.

Periodic visits for sample collection and assessments over 2 years

Long-term Monitoring

Duration - Up to 2 years

Participants are monitored to evaluate the diagnostic value of tests and observe pancreatic disease outcomes.

Ongoing observation through scheduled assessments

Trial Site Locations

Total: 1 location

1

Ning Zhong

Jinan, Shandong, China, 250063

Actively Recruiting

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Research Team

Z

Zhen Li, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

6

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