Clinical trial NCT06041009: Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations
Official title: Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations: A Multicenter, Prospective, Diagnostic Clinical Cohort Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Ductal Adenocarcinoma
Pancreatic Diseases
Pancreatic Elastase 1
Pancreatic Neuroendocrine Tumor
Pancreatitis
Pancreatic Neoplasms
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: First Affiliated Hospital of Guangxi Medical University
name: Wuhan Union Hospital, China
name: LanZhou University
First posted: 2023-09-18
Enrollment: 2100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pancreatic cancer patients at high risk, patients with pancreatic cancer, benign pancreatic disease, borderline malignant disease, and abnormal elevation of CA199, as well as patients with other diseases without pancreatic disease are included. The Pancreatic cancer patients at high risk are those which are hereditary pancreatic cancer patients at high risk, chronic pancreatitis, new diabetes mellitus, or PCN pancreatic cystic tumor patients.

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.

Primary outcomes:
measure: The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
timeFrame: 2 years
Secondary outcomes:
measure: The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
timeFrame: 2 years
measure: The content of elastase 1
timeFrame: 2 years
measure: The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
timeFrame: 2 years
measure: The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
timeFrame: 2 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Ning Zhong
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Ning Zhong, MD
role: PRINCIPAL_INVESTIGATOR
References: