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NCT Number: NCT06041009

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

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.

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Key information

Conditions

Pancreatic Ductal Adenocarcinoma Adenoma Adenoma, Islet Cell Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Elastase 1 Pancreatic Neoplasms Pancreatic Neuroendocrine Tumor Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ning Zhong

Jinan, Shandong, 250063, China

Location status: Recruiting

Location contact

Ning Zhong, MD

CONTACT

Zhen Li, MD

CONTACT

[email protected]

18560086106

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

(1) 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.

Treatment and study plan

Pancreatic elastase-1 in blood serum

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.

Other names: Multiomics in blood serum or tissue

Primary outcomes

  1. The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)

    Time frame: 2 years

    The diagnostic value of diagnostic model in diagnosing PDAC, especially early resectable PDAC.

Secondary outcomes

  1. The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)

    Time frame: 2 years

    The diagnostic value of diagnostic model versus EUS or other imaging examinations combined with diagnostic model in diagnosing PDAC.

  2. The content of elastase 1

    Time frame: 2 years

    The content of elastase-1 in cystic fluid and serum are measured (units: ng/dl)

  3. The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)

    Time frame: 2 years

    The ability of diagnostic models, multi-omics novel tumor markers, and common tumor markers to distinguish PDAC, benign pancreatic disease, borderline malignant disease, patients with abnormally elevated CA199, and controls without pancreatic disease.

  4. The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)

    Time frame: 2 years

    The diagnostic value of the diagnostic model, new tumor markers of multi-omics, and the common tumor markers to distinguish pancreatic tumors of different sites and sizes.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhen Li, MD

CONTACT

[email protected]

18560086106

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital, Sun Yat-Sen University
  • LanZhou University
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 18, 2023
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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