Multi-center and Multi-omics Mechanism Research of Gut Microbiota and Metabonomics in Borrmann Type IV Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 6
- 主要终点
- Participants' characteristics
研究概览
简要总结
To evaluate the correlation between gut microbiota and metabolites in Borrmann type IV gastric cancer; To find the effects of microflora and metabolites on target organs; To detect the mechanism of key flora and metabolite by in vitro and in vivo experiments; To construct models of gut microbiota and metabonomics by machine learning.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who sign informed consent.
- •Borrmann classification of gastric cancer is determined by more than 2 pathologists.
- •Patients with BMI 24-
- •Karnofsky (KPS) score >80.
排除标准
- •Patients who take any aspirin, antibiotics, prebiotics, or probiotics within 4 weeks and steroids or immunosuppressants within 6 months prior to specimen collection.
- •Patients who complicate with other malignant tumors.
- •Patients who complicate with diabetes, hypertension, heart disease and infectious diseases.
- •Patients who complicate with inflammatory bowel disease or irritable bowel syndrome.
- •Patients with metastasis.
结局指标
主要结局
Participants' characteristics
时间窗: 1 day
To obtain participants' characteristics, including age, gender, alcohol consumption, body mass index, smoking, medications.
Microbial community structure
时间窗: 1 day
To assess participants' microbiome composition in faecal samples, inclding microbial diversity and richness.
Metabolite composition
时间窗: 1 day
To measure the metabolite profiles in participants' faecal samples and serum samples, involving Bile acids, short chain fatty acids, TMAO and related metabolites, amino acids, fatty acids, organic acids, flavonoids, plant hormones, neurotransmitters.
Microbes-metabolites correlations
时间窗: 1 day
To assess the correlations of gut microbiota and metabolites by Spearman's correlation analysis.
Response of target organ
时间窗: 1 day
To find the effects of microflora and metabolites on target organ by transcriptome sequencing.
次要结局
未报告次要终点
研究者
Kai Li
Deputy Director of surgical Oncology
First Hospital of China Medical University