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

NCT ID: NCT06041009

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-05

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with PDAC

Pancreatic elastase-1 in blood serum

Intervention Type DIAGNOSTIC_TEST

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.

Individuals at high risk for PDAC

Pancreatic elastase-1 in blood serum

Intervention Type DIAGNOSTIC_TEST

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.

Group of neuroendocrine neoplasm of pancreas

Pancreatic elastase-1 in blood serum

Intervention Type DIAGNOSTIC_TEST

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.

Group of solid pseudopapillary tumor of pancreas

Pancreatic elastase-1 in blood serum

Intervention Type DIAGNOSTIC_TEST

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.

Group of abnormally elevated CA19-9

Pancreatic elastase-1 in blood serum

Intervention Type DIAGNOSTIC_TEST

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.

Controls without pancreatic disease or elevated CA19-9

Pancreatic elastase-1 in blood serum

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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Pancreatic 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Multiomics in blood serum or tissue

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

LanZhou University

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ning Zhong, MD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

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Ning Zhong

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhen Li, MD

Role: CONTACT

18560086106

Facility Contacts

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Ning Zhong, MD

Role: primary

Zhen Li, MD

Role: backup

18560086106

Other Identifiers

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2023SDU-QILU-4

Identifier Type: -

Identifier Source: org_study_id

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