Correlation Analysis of TCM Syndromes, TCM Constitution Types, Intestinal Microbial Evolution and Tumor Biological Characteristics in Colorectal Cancer Patients Before and After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- According to the 16s rDNA sequencing results, analyze the differences in intestinal flora of colon cancer patients with different TCM syndromes and TCM constitutions before and after surgery and their correlations
研究概览
简要总结
Guided by the idea of combining disease differentiation with syndrome differentiation in traditional Chinese medicine, this study used the form of questionnaire to summarize the changes of TCM syndromes, TCM constitution types in colorectal cancer patients before and after surgery. The Next-generation sequencing technology was used to explore the changes and differences of intestinal microorganisms before and after surgery. The correlation between changes of TCM syndromes, TCM constitution types, intestinal microbial evolution and tumor biological characteristics in colorectal cancer patients before and after surgery was analyzed. To explore the rationality of TCM in the prevention and treatment of colorectal cancer recurrence and metastasis in order to guide the individualized treatment and dietary regulation of TCM.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preoperative abdominal CT, colonoscopy and pathological examination were diagnosed as colorectal malignant tumor patients;
- •Having surgical indications;
- •Patients who were not treated with antibiotics or microbiological agents one week before surgery;
- •Patients who had not received radiotherapy and chemotherapy before surgery;
- •Patients or their legal representatives informed and agreed to participate in this clinical trial and signed a written informed consent;
排除标准
- •Have other cancer history;
- •Patients who have received invasive treatment within the past three months;
- •Inflammatory bowel disease such as ulcerative colitis or crohn's disease;
- •Combined with intestinal obstruction or intestinal perforation for emergency surgery;
- •Psychiatric history, can not join and standardize the completion of clinical investigators;
- •Pregnant or nursing women;
- •Patients treated with antibiotics or microbiological agents one week before surgery;
- •People have incomplete data;
结局指标
主要结局
According to the 16s rDNA sequencing results, analyze the differences in intestinal flora of colon cancer patients with different TCM syndromes and TCM constitutions before and after surgery and their correlations
时间窗: 1 month
According to the 16s rDNA sequencing results, characterize the intestinal microbiota characteristics of colon cancer patients with different TCM syndrome types and TCM constitutions before and after surgery
时间窗: 2 year
次要结局
未报告次要终点
研究者
Wei Xu
Professor
First Affiliated Hospital of Harbin Medical University