Detection of Plasma Circulating Tumor DNA in Gastric Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients
研究概览
简要总结
The aim of this study is to develop a protocol for detection of circulating tumor DNA (ctDNA) in plasma of patients with early stages of gastric cancer.
详细描述
Gastric cancer (GC) is the fifth most common cancer worldwide and the third leading cause of cancer deaths. Earlier detection of GC can dramatically increases the five-year survival rate up to > 90%. The current endoscopy and tissue biopsy remain excessively expensive for middle-income nations, in addition to being fairly invasive, with possible complications. Additionally, most of serum-based biomarkers such as carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 72-4 (CA72-4), and carbohydrate antigen 125 (CA125) are not recommended for detection of GC due to the limit of specificity and sensitivity in the early stages of GC. Thus, it is essential to identify new biomarkers for diagnosis of early stages of GC. In this study, the investigators develop an ultradeep massive parallel sequencing (MPS) assay to detect tumor derived mutations (TDM) in plasma of early stages of GC. This study provides proof-of-principle for eventual clinical employment of circulating DNA, via liquid biopsy, for detection of early stages of GC.
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 stage (I, II and IIIA) gastric adenocarcinoma
- •Naivety to treatment.
- •No known other concomitant cancer diagnosis
- •Signed informed consent
排除标准
- •Pathologically late stage (stage IIIB and IV) or metastatic gastric adenocarcinoma
- •Underwent any type of treatment
- •Unable to undergo biopsy
结局指标
主要结局
The sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients
时间窗: 1 months after collecting blood and specimen
sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients
次要结局
- Limit of detection (LOD): the lowest variant allelic frequency that can be reliably detected(1 months after collecting blood and specimen)
- The concordance rate of mutation results between plasma and tissue biopsy assay(1 months after collecting blood and specimen)