Early Detection and Post-operative Monitoring of Gastric Cancer Using Circulating DNA in Blood Samples
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,197
- 试验地点
- 1
- 主要终点
- The performance of the new biomarkers in the post-operative monitoring of gastric cancer
研究概览
简要总结
This study is to determine the performance of non-invasive new multi-target biomarkers in the early detection and post-operative monitoring of gastric cancer.
详细描述
This study aims to develop and validate a new non-invasive detection method for early detection and postoperative monitoring of gastric cancer in the blood. Sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarkers in the diagnosis of gastric cancer will be compared with that of tumor biomarkers CA19-9, CEA, and CA72-4. Blood will also be collected at various time points post-operatively. The investigators will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. The investigators will also determine whether these new biomarkers detect tumor recurrence and metastasis earlier than methods currently used in the clinic such as imaging and tumor biomarkers CA19-9, CEA, and CA72-4.
This study is a prospective and multi-center study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject age over
- •Subject has stomach discomfort, and seek medical attention at the Gastric Surgery Department of our center.
- •Subject has or will have gastroscopy and/or pathological examination results at this center.
- •Subject must be able to fully understand the informed consent form and be able to personally sign it.
排除标准
- •Subject has serious heart, liver, kidney dysfunction, or mental illness.
- •Subject diagnosed previously with any kind of malignant tumor.
- •Subject is known to be infected with HIV or other related diseases (considering interference from the use of immune drugs).
- •Subject is receiving targeted drugs, immunosuppressants, immunomodulators, and biological therapies.
- •Researchers believe that subject is not suitable for enrollment.
- •Subject can not supply sufficient sample to complete this experiment.
结局指标
主要结局
The performance of the new biomarkers in the post-operative monitoring of gastric cancer
时间窗: 2 years
Determine whether the new detection system can detect tumor recurrence and metastasis earlier than imaging and tumor marker CA19-9, CEA, and CA72-4.
The performance of the new detection system for gastric cancer (GC) detection
时间窗: 2 years
Evaluate sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarker for the diagnosis of gastric cancer.
次要结局
- The performance of the new biomarkers as prognostic biomarkers(2 years)
- Compare the performance of the new biomarkers for GC detection with the conventional tumor markers(2 years)