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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06041009

Enrollment

2100

Registered

2023-09-18

Start date

2023-05-05

Completion date

2025-09-30

Last updated

2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Diseases, Pancreatic Ductal Adenocarcinoma, Pancreatic Elastase 1, Pancreatic Neoplasms, Pancreatic Neuroendocrine Tumor, Pancreatitis

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.

Interventions

DIAGNOSTIC_TESTPancreatic elastase-1 in blood serum

Serum samples were collected from each patient to detect serum multiomics and pancreatic elastase-1 (PE-1). We examine multiomics in the pancreatic tissue collected from the patient who had undergone surgery or the necessary puncture examination and signed the informed consent form.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)	2 years	The diagnostic value of diagnostic model in diagnosing PDAC, especially early resectable PDAC.

Secondary

Measure	Time frame	Description
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)	2 years	The diagnostic value of diagnostic model versus EUS or other imaging examinations combined with diagnostic model in diagnosing PDAC.
The content of elastase 1	2 years	The content of elastase-1 in cystic fluid and serum are measured (units: ng/dl)

Countries

China

Contacts

Primary ContactZhen Li, MD

qilulizhen@sdu.edu.cn18560086106

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026