Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations
Recruiting · NCT06041009 · Observational (researchers observe without assigning treatment) · Lead sponsor: Qilu Hospital of Shandong University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a prospective cohort study. The investigators enroll subjects with pancreatic ductal adenocarcinoma (PDAC), individuals at high risk for PDAC, patients with other pancreatic diseases, patients with CA19-9 elevation and controls without pancreatic disease. This study aims to establish a diagnostic prediction model by using elastase 1, common clinical serological examinations, and imaging examinations including endoscopic ultrasonography (EUS), and to explore the diagnostic ability of the model in the high-risk population of PDAC. Besides, the investigators search for new biomarkers by multi-omics studies of serum and pancreatic tissues to further improve the diagnostic performance of this model. In conclusion, this study seeks a robust diagnostic prediction model to diagnose PDAC, especially early resectable PDAC.
Who can take part
Inclusion criteria
- Case groups (matching any of the following):
- Patients with pancreatic cancer with recognized diagnostic criteria or conclusions.
- Patients who are the high-risk group of pancreatic cancer.
- Patients with solid pseudo papilloma and neuroendocrine tumors of pancreas with recognized diagnostic criteria or conclusions.
- Patients with other diseases with abnormally elevated CA19-9.
- Control group:
- Patients without pancreatic disease assessed by laboratory tests and imaging examinations have no CA19-9 elevation.
Exclusion criteria
- Patients who are younger than 18 years of age.
- Patients with suspected pancreatic malignant lesions but has no confirmed imaging or pathological diagnosis.
- Patients who have not signed informed consent.
Where it is running
1 location listed.
- Ning Zhong - Jinan, Shandong, China