NCT06325891招募中不适用
Microbiota Diversity and Composition in Gastric Cancer by Gastric Mucosal Brushing: a Cross-sectional Case-control Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Microbiome analysis using gastric mucosal brushing
研究概览
简要总结
Many studies have shown a significant change of diversity and composition in gut microbiota across the gastric carcinogenesis process, particularly in patients with gastric cancer. However, there has been no analysis of gastric microbiota using the mucosal brushing technique, despite its favoring benefit in microbiota study. Therefore, this study aims to evaluate microbiota profile in patients with gastric cancer, compared to those without gastric cancer by using mucosal brush sampling. This will improve current knowledge of the potential role of the microbiome in patient gastric cancer as a future biomarker marker using brushing sampling.
详细描述
- Gut microbiota play role in mucosal immune response and strength gut integrity. The dysbiosis or imbalance of microbiota changes microecology and activates the inflammation in gastrointestinal mucosa. It also has been implicated in gastric carcinogenesis.
- Up to date, many studies have shown a significant change of diversity and composition in gut microbiota across the gastric carcinogenesis process, particularly in patients with gastric cancer. Although, Helicobacter pylori infection is potential class I carcinogen in initial step of gastric carcinogenesis, only between 1% and 3% of patient with H. pylori infection develop gastric cancer. In addition, many current studies have revealed significant change in microbiome profile of patient with H. pylori-negative gastric cancers. Many studies have revealed significant change in microbiome profile of patient with H. pylori-negative gastric cancers. Therefore, the investigators have hypothesized that unidentified non-H. pylori bacteria play a role in gastric cancer development.
- However, most of current studies of gastric microbiota in patients with gastric cancer have been conducted in Eastern Asia, particularly in China and Korea, there is still no published data from Thailand. Moreover, all previous studies have used gastric tissue biopsy method. There has been no analysis of gastric microbiota using the mucosal brushing technique, despite its favoring benefit in microbiota study
- This study is pilot phase, cross-sectional and case-control study that aims to evaluate microbiota profile in patients with gastric cancer, compared to those without gastric cancer by using mucosal brush sampling.
- According to previous studies, H. pylori had significant impact on the composition of gastric microbiota. Presence of H. pylori could affect the result of the study. Therefore pre-specified subgroup analysis of H.pylori infection and non-H.pylori infection will be perform.
- Study protocol include
- Age, gender, BMI, smoking history, history of PPI use within 3 months, history of infection within 2 weeks, history of antibiotic use within 3months, history of probiotic use within 3months, history of intraabdominal surgery, history of dietary supplement and herbal use will be recorded in case record form.
- After consent, standard EGD will be performed.
- The gastric mucosa using mucosal brushing with sterile sheathed brush, gastric mucosal biopsy by standard forceps biopsy and rapid urease test for evaluate H.pylori status will be done respectively.
- The gastric mucosal specimen will be keep in sterile tube and immediate keep in freezing at -80C (allow room temperature <2 hr) for 16sRNA sequencing analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (≥18 years of age) and undergoing esophagogastroduodenoscopy (EGD)
- •Gastric cancer group: patients with pathological diagnosis of high-grade dysplasia or gastric cancer
- •Control group: patients with no or minimal upper GI symptoms and current EGD appear normal or minimal gastritis
- •Informed consent obtained
排除标准
- •Had a history of GI or hepatobiliary surgery
- •Had a history of recent (within 4 weeks) antibiotic or probiotic use
- •Had a history of PPI use within 2 weeks
结局指标
主要结局
Microbiome analysis using gastric mucosal brushing
时间窗: Through study completion, estimated 1.5 yr
Gastric mucosal-associated microbiota in patients with gastric cancer and those without gastric cancer using mucosal brush sampling by 16S rRNA sequencing. Including microbiota diversity and composition.
次要结局
- Microbiome analysis using gastric mucosal biopsy(Through study completion, estimate 1.5 years)
研究者
Rapat Pittayanon
Associate Professor
King Chulalongkorn Memorial Hospital
研究点 (2)
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