Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The specificity of MRD detection using ctDNA as the biomarker
研究概览
简要总结
This study aims to evaluate the use of Next Generation Sequencing (NGS) to detect circulating tumor DNA in gastric cancer patients after gastrectomy
详细描述
Gastric cancer is the fourth most common cancer in Vietnam with high mortality rate. Patients at early stages undergo radical gastrectomy with curative intent, but the remaining tumor cells, termed as minimal residual disease (MRD), can later cause relapse. Conventional methods to monitor MRD such as imaging and blood tests for biomarkers such as CEA are not sensitive and specific enough. ctDNA has recently emerged as a promising noninvasive marker with high accuracy to monitor MRD and detect relapse in many cancers such as breast and colorectal cancers. However, its application in gastric cancer has not been extensively evaluated. Therefore, this study aims to use advanced NGS technologies to detect ctDNA in liquid biopsy as a biomarker to monitor MRD after radical gastrectomy.
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
- 否
入选标准
- •Male or Female patients aged 18 years and older
- •Histologically proven primary gastric adenocarcinoma before surgery
- •Clinical stage is locally advanced cT2-4a any N and M0
- •In initial evaluation, patient can undergo radical gastrectomy and lymphadenectomy
- •No preoperative therapy, including chemotherapy and radiotherapy
- •No known cancer diagnosis within last five years
- •Signed informed consent
排除标准
- •Gastrectomy cannot be achieved during operation due to metastasis
- •Patient fails to follow-up and provide postoperative samples
结局指标
主要结局
The specificity of MRD detection using ctDNA as the biomarker
时间窗: 2 years after surgery
The percentage of positive ctDNA detection among participants who do not experience disease recurrence or metastasis
The sensitivity of MRD detection using ctDNA as the biomarker
时间窗: 2 years after surgery
The percentage of positive ctDNA detection among participants who experience disease recurrence or metastasis
次要结局
- Leading time between ctDNA detection and cancer recurrence detected by conventional methods(2 years after surgery)
- Mean ctDNA level (MTM/ml) of gastric cancer before operation(Within 14 days before operation)
- Mutation profile of gastric cancer(Within 14 days before operation)