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临床试验/NCT03835663
NCT03835663进行中(未招募)不适用

Identification of Bacteria Responsible for the the Development of Oesophago-gastric Cancer

Imperial College London1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年6月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Difference in the bacterial composition of the gastric mucosa between the three groups

研究概览

简要总结

Gastric and oesophageal (OG) cancer associated with poor long term outcome as overall less than 25% of patients survive for more than 5 years due to late recognition of the disease. Growing evidence suggests an important role for bacteria in OG cancer and gastro esophageal reflux disease (GORD) development. About 1 in 10 people suffer from GORD and this one of the most common conditions leading to gastric and oesophageal cancer.

In GORD surgical therapy is the most successful preventing cancer but around 85% of patient experience complications afterwards. Acid suppressing medications are reducing the risk of oesophageal cancer but equally increasing the risk of gastric cancer. They also shorten patients' life expectancy and often fail to provide relief. Analysis of stool samples of patients with GORD demonstrated different gut bacterial compositions to normal and rather resembled the one found in cancer.

There is a clear need to improve the outcome of OG cancer. This could be achieved by identifying bacteria responsible for cancer development in gastric tissue, gastric content and saliva and potentially eliminate them hence avoid the development of cancer.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Patients who deemed necessary for an upper gastro intestinal endoscopy for clinical reasons and consent for additional gastric mucosal biopsies for study purposes

排除标准

  • Patients who have upper GI malignancy

结局指标

主要结局

Difference in the bacterial composition of the gastric mucosa between the three groups

时间窗: Samples are collected on the day of endoscopy following min 6 hours starvation and preserved on -80C

Bacterias found in the stomach will be identified with 16s RNA analysis. The type of bacterias identified will be compared between the three groups.

Difference in the amount of bacteria of the gastric mucosa between the three previously described groups.

时间窗: Samples are collected on the day of endoscopy following min 6 hours starvation and preserved on -80C

Bacterias found in the gastric mucosa will be quantified and compared within the three groups.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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