Biomarkers of Pancreatic Cancer and New Way to Detection

NCT ID: NCT04549064

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-12-30

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.

Conditions

Pancreatic Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with 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.

diagnosis of pancreatic cancer

Intervention Type: DIAGNOSTIC_TEST

Diagnosis of pancreatic cancer based on the concentration of serum biomarkers

Healthy Control

healthy controls had no history of benign pancreatic diseases and other benign and malignant tumors.

diagnosis of pancreatic cancer

Intervention Type: DIAGNOSTIC_TEST

Diagnosis of pancreatic cancer based on the concentration of serum biomarkers

Interventions

diagnosis of pancreatic cancer

Diagnosis of pancreatic cancer based on the concentration of serum biomarkers

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

West China Hospital

OTHER

Sponsor Role: collaborator

Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

han su xia, professor

Role: STUDY_CHAIR

First Affiliated Hospital of Xian Jiaotong University

Locations

First Affiliated Hospital of Xian Jiaotong University

Xi’an, Shanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

wang qi, master

Role: CONTACT

wangqill1024@163.com

0086-15991439170

Facility Contacts

han su xia, professor

Role: primary

shan87@mail.xjtu.edu.cn

0086-18991232029

Other Identifiers

81672921

Identifier Type: -

Identifier Source: org_study_id