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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04549064
Other study ID # 81672921
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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