Screening for pancreatic cancer using elastase-1 and other tests
Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations: A Multicenter, Prospective, Diagnostic Clinical Cohort Study.
This study is trying to find better ways to diagnose pancreatic cancer early by testing different blood tests and imaging techniques in people at high risk for the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06041009 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enroll individuals with pancreatic ductal adenocarcinoma (PDAC), those at high risk for PDAC, and patients with other pancreatic diseases to develop a diagnostic prediction model. The study will utilize pancreatic elastase-1 levels, standard clinical serological tests, and imaging techniques such as endoscopic ultrasonography (EUS). Additionally, researchers will investigate new biomarkers through multi-omics studies of serum and pancreatic tissues to enhance the model's diagnostic accuracy, particularly for early-stage resectable PDAC. The goal is to establish a robust method for diagnosing pancreatic cancer in high-risk populations.
Who should consider this trial
Good fit: Ideal candidates include patients with pancreatic cancer, those at high risk for developing pancreatic cancer, and individuals with elevated CA19-9 levels.
Not a fit: Patients under 18 years old or those without confirmed pancreatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnosis of pancreatic cancer, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using biomarkers for pancreatic cancer detection, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Case groups (matching any of the following): 1. Patients with pancreatic cancer with recognized diagnostic criteria or conclusions. 2. Patients who are the high-risk group of pancreatic cancer. 3. Patients with solid pseudo papilloma and neuroendocrine tumors of pancreas with recognized diagnostic criteria or conclusions. 4. Patients with other diseases with abnormally elevated CA19-9. Control group: (1) Patients without pancreatic disease assessed by laboratory tests and imaging examinations have no CA19-9 elevation. Exclusion Criteria: 1. Patients who are younger than 18 years of age. 2. Patients with suspected pancreatic malignant lesions but has no confirmed imaging or pathological diagnosis. 3. Patients who have not signed informed consent.
Where this trial is running
Jinan, Shandong
- Ning Zhong — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Ning Zhong, MD — Qilu Hospital of Shandong University
- Study coordinator: Zhen Li, MD
- Email: qilulizhen@sdu.edu.cn
- Phone: 18560086106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.