Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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