Prospective Observational Study of Peritoneal Lavage for Early Detecting Gene Mutation of Peritoneal Metastasis of Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- prognostic molecular markers
研究概览
简要总结
Our study aims to improve sensitivity and accuracy of detecting abdominal free cancer cells in patients with gastric cancer.
详细描述
Gastric cancer (GC) remains one of the most common causes of cancer-related mortality worldwide. Surgery has always been considered as the most effective treatment for GC. Peritoneal metastasis is the common pattern of postoperative recurrence, especially patients with T4 stage or serosal invasion. What is worse, patients with peritoneal metastasis have a poor prognosis. However, it is often difficult to diagnose peritoneal metastasis at an early stage. As we know, the implantation of peritoneal free cancer cells exfoliating from serosa-invasive tumors is main reason of peritoneal seeding. Cytological examination of peritoneal lavage fluid is always performed to predict peritoneal micrometastases. However, more than half of patients with negative cytological results develop peritoneal recurrence. Low sensitivity and poor negative predictive value of this method have heralded the development of advanced techniques in detecting peritoneal free cancer cells.
In this study, novel genetic techniques will be used to detect mutated DNA of shed cancer cells in abdominal cavity. The present clinical trial aims to find a better tool to detect abdominal micrometastasis in GC patients, which may become a valid clinical index to predict postoperative relapse and direct treatment.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
- •PS (ECOG) of 0 or 1 and expected to survive more than 6 months.
- •Written informed consent from the patient.
- •Patients suffering gastric cancer and non-cancerous disease planned to have laparotomy.
排除标准
- •Female in pregnancy or lactation.
- •Patients participating in any other clinical trials currently,or participated in other trails within 1 months.
- •Patients with poor compliance or considered to be poor compliance.
结局指标
主要结局
prognostic molecular markers
时间窗: 3-year
prognostic molecular markers
次要结局
- OS(3-year)
- DFS(3-year)
