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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06041009
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Qilu Hospital of Shandong University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ning Zhong, MD
Principal Investigator Affiliation	Qilu Hospital of Shandong University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pancreatic Ductal Adenocarcinoma, Pancreatic Diseases, Pancreatic Elastase 1, Pancreatic Neuroendocrine Tumor, Pancreatitis, Pancreatic Neoplasms

Arms & Interventions

Arms

: Patients with PDAC

: Individuals at high risk for PDAC

: Group of neuroendocrine neoplasm of pancreas

: Group of solid pseudopapillary tumor of pancreas

: Group of abnormally elevated CA19-9

: Controls without pancreatic disease or elevated CA19-9

Interventions

Diagnostic Test: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ning Zhong, Jinan, Shandong, China

Status

Recruiting

Address

Ning Zhong

Jinan, Shandong, 250063

Site Contact

Ning Zhong, MD

[email protected]

18560086106

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