Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Intestinal Microbiota Diversity Differences Between Colorectal Cancer Patients With and Without Peritoneal Metastasis
研究概览
简要总结
Colorectal cancer (CRC) is one of the most common and deadly cancers worldwide. About 1 in 4 people with CRC already have cancer spread (metastasis) when first diagnosed, and about half develop spread during their illness. Recent research shows that bacteria living in the gut and even within tumors might play an important role in how cancer spreads.
The goal of this study is to better understand how bacteria might influence the spread of colorectal cancer. The main questions the investigators aim to answer are:
Are there differences in bacteria between people whose cancer has spread and those whose cancer has not spread? Could certain bacteria help predict which cancers might spread?
To answer these questions, the investigators will:
Collect different types of samples from participants:
Tumor tissue Normal tissue near the tumor Tissue from where cancer has spread Stool samples before surgery Study the bacteria in these samples using advanced testing methods Compare bacterial patterns between different groups
People can take part in this study if they:
Are between 18 and 75 years old Have colorectal cancer confirmed by doctors Have not taken antibiotics recently Do not have immune system problems
This research may help us:
Understand why some colorectal cancers spread Find new ways to predict which cancers might spread Develop better treatments for colorectal cancer
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 75 years
- •Pathologically confirmed colorectal cancer
- •Clearly defined clinical staging: including imaging or pathologically confirmed metastatic colorectal cancer (stage M1) and colorectal cancer without distant metastasis (stage M0)
- •Expected survival ≥ 3 months
- •Voluntary participation and signed informed consent
排除标准
- •Use of probiotics, antibiotics, or immunosuppressive agents within 1 month before surgery
- •Preoperative complete intestinal obstruction or gastrointestinal perforation
- •Intraoperative gastrointestinal perforation or tumor rupture
- •Previous history of gastrointestinal surgery (excluding colorectal cancer surgery, appendectomy, and cholecystectomy) or concurrent severe gastrointestinal diseases such as inflammatory bowel disease
- •Concurrent active systemic immune or infectious diseases, including severe allergies, rheumatoid arthritis, systemic lupus erythematosus, viral hepatitis, acquired immunodeficiency syndrome, etc.
- •Concurrent unhealed primary malignant tumors
- •Severe organ dysfunction or failure
- •Other conditions deemed unsuitable for this study by the investigator
结局指标
主要结局
Intestinal Microbiota Diversity Differences Between Colorectal Cancer Patients With and Without Peritoneal Metastasis
时间窗: Fecal samples collected at patient's first hospital admission; tissue specimens collected during surgery. All specimens analyzed within 6 months after collection.
Comparison of microbial diversity between metastasis and non-metastasis groups, including alpha diversity (Chao1 index for species richness, Shannon index for species diversity) and beta diversity (Bray-Curtis distance, UniFrac distance). These measurements will evaluate differences in intestinal microbiota composition related to colorectal cancer peritoneal metastasis.
次要结局
未报告次要终点