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临床试验/NCT04549064
NCT04549064Unknown不适用

Identification of AREG for the Detection of Pancreatic Cancer By Biosensor

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
Diagnosis of Pancreatic Cancer

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Diagnosis of Pancreatic Cancer

时间窗: through study completion, an average of 1 year

Diagnosis based on the concentration of serum biomarkers

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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