Biomarkers of Pancreatic Cancer and New Way to Detection

Pancreatic Cancer Clinical Trial

Official title:

Identification of AREG for the Detection of Pancreatic Cancer By Biosensor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04549064
• Other study ID #: 81672921
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: wang qi, master
• Phone: 0086-15991439170
• Email: wangqill1024[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• diagnosis of pancreatic cancer
Diagnosis of pancreatic cancer based on the concentration of serum biomarkers

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shanxi

Sponsors (3)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Health Science Center of Xi'an Jiaotong University, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of Pancreatic Cancer	Diagnosis based on the concentration of serum biomarkers	through study completion, an average of 1 year