Clinical trial NCT04549064: Biomarkers of Pancreatic Cancer and New Way to Detection
Official title: Identification of AREG for the Detection of Pancreatic Cancer By Biosensor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: Xi'an Jiaotong University
First posted: 2020-09-16
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Total collection of pancreatic cancer: healthy control about 300：300. The study population met the inclusion and exclusion criteria.

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.

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.

Primary outcomes:
measure: Diagnosis of Pancreatic Cancer
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: han su xia, professor
role: STUDY_CHAIR
References: