Biomarkers of Pancreatic Cancer and New Way to Detection

• Conditions: Pancreatic Cancer
• Interventions: Diagnostic Test: diagnosis of pancreatic cancer

• Registration Number: NCT04549064
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

Amphoteric regulatory protein (AREG), a member of epidermal growth factor (EGF) family, is expressed in many tumors.Our study confirmed that the expression of AREG in the serum of patients with pancreatic cancer is significantly higher than that of patients with benign pancreatic diseases and healthy people, which is expected to become a new early serum marker of pancreatic cancer. The serum concentration of AREG was detected by traditional ELISA and compared with CA-199, which was a conventional tumor marker of pancreatic cancer. Next, we compare the advantages of using sensor to detect AREG compared with ELISA.

Detailed Description

Serum was collected ： pancreatic cancer : healthy control =200:200 Clinical data were collected: age, gender, diagnosis, cancer stage, CA199 level at initial diagnosis, histopathological type, etc. The informed consent of the subjects was obtained before the study, and all experimental procedures were approved by ethics.

Draw a summary table of patient characteristics. The level of AREG was detected by ELISA kit and compared with CA199.

Fabrication of a new electrochemical biosensor. Characterization of sensor performance.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-16
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-23
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• The healthy control group had no history of benign pancreatic diseases and other benign and malignant tumors.
• Patients with pancreatic cancer did not receive any anti-cancer treatment and had no history of other malignant tumors.The diagnosis of pancreatic cancer patients is based on the final pathological diagnosis; the cancer staging is based on AJCC staging manual.

Exclusion Criteria

• Uncontrolled active infection.
• Acute or chronic pancreatitis.
• It is accompanied by other uncontrolled malignant tumors.
• Any other uncontrolled active disease that prevents participation in the trial.
• Having a history of mental illness that is difficult to control.
• In the opinion of the investigator, the presence of medical or psychiatric history or laboratory abnormalities may increase the risk associated with participation in the study or the administration of the study drug, or may interfere with the interpretation of the results.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with pancreatic cancer	diagnosis of pancreatic cancer	Patients with pancreatic cancer did not receive any anti-cancer treatment and had no history of other malignant tumors.The diagnosis of pancreatic cancer patients is based on the final pathological diagnosis; the cancer staging is based on AJCC staging manual.
Healthy Control	diagnosis of pancreatic cancer	healthy controls had no history of benign pancreatic diseases and other benign and malignant tumors.

Primary Outcome Measures

Name	Time	Method
Diagnosis of Pancreatic Cancer	through study completion, an average of 1 year	Diagnosis based on the concentration of serum biomarkers

Trial Locations

Locations (1)

First Affiliated Hospital of Xian Jiaotong University; 🇨🇳 Xi'an, Shanxi, China