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临床试验/NCT03314649
NCT03314649已完成不适用

Prospective Observational Study of Peritoneal Lavage for Early Detecting Gene Mutation of Peritoneal Metastasis of Gastric Cancer

Fudan University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年12月21日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dazhi Xu

Professor

Fudan University

研究点 (1)

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