NCT06041009 Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations
| NCT ID | NCT06041009 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Qilu Hospital of Shandong University |
| Condition | Pancreatic Ductal Adenocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,100 participants |
| Start Date | 2023-05-05 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,100 participants in total. It began in 2023-05-05 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Ning Zhong, MD
PRINCIPAL INVESTIGATOR
Qilu Hospital of Shandong University
Frequently Asked Questions
Who can join the NCT06041009 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Ductal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06041009 currently recruiting?
Yes, NCT06041009 is actively recruiting participants. Contact the research team at qilulizhen@sdu.edu.cn for enrollment information.
Where is the NCT06041009 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06041009 clinical trial?
NCT06041009 is sponsored by Qilu Hospital of Shandong University. The principal investigator is Ning Zhong, MD at Qilu Hospital of Shandong University. The trial plans to enroll 2,100 participants.