Structural of the Gut Mucosal Microbiota is Associated With Colorectal Cancer Relapses After Curative Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Transcriptional changes in gut microbiota
研究概览
简要总结
Colonic microbiome has been found to contribute to the development of colorectal cancer. We speculate that gut microbiota related to colorectal cancer relapse after curative treatment. This study aim to discover if any difference of gut microbiota exist in patients who suffer from cancer relapse compared with patients who do not. Finally develop patient-centred programmes of surveillance protocols base on microbiota analysis.
详细描述
Treatments for colorectal cancer of all stages have evolved considerably over the past two decades, resulting in improved long-term outcomes. After curative treatment, however, 30% of patients with stage I-III and up to 65% of patients with stage IV colorectal cancer develop recurrent disease.
The human colon plays host to a diverse and metabolically complex community of microorganisms. While the colonic microbiome has been found to contribute to the development of colorectal cancer. Investigators speculate that gut microbiota related to colorectal cancer relapse after curative treatment.
Patients are routinely offered surveillance in order to detect disease recurrence at an early, asymptomatic stage, with the intention of improving survival. Nevertheless, controversy continues to surround the optimal surveillance protocols. Investigators aim to discover if any difference of gut microbiota is exist in patients who suffer from relapse compared with patients who do not.
Future surveillance after colorectal cancer treatment should focus on risk-stratification and should incorporate current knowledge on risk of recurrence in relation to the biology of the tumour as well as gut microbiota feature. Finally investigators will develop patient-centred programmes of surveillance protocols base on microbiota analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requirements of informed consent and assent of participant, parent or legal guardian as applicable
- •Patients with colorectal cancer scheduled for radical coloproctectomy and between the age of 18 and 75 years old without considering sex.
- •Patients with BMI= 18.5-23.9
- •Participants can follow the visit plan
排除标准
- •Patients with colorectal cancer with distant metastasis
- •Chronic renal diseases and hepatic cirrhosis
- •Chronic ischemic heart disease with unstable angina, chronic heart failure at class III or IV and acute myocardial infarction in the last 6 months
- •Individuals with a history of Chronic diarrhea
- •Individuals with a history of Diabetes mellitus
- •Individuals with a history of Hypertension
- •Individuals with a history of autoimmune diseases
- •Use of antibiotics and probiotics 3 mouth before samples collection
- •Individuals with a history of abdominal operation due to any reason
- •Individuals with any history of cancer other than colorectal cancer
- •Individuals with Inflammatory bowel disease
结局指标
主要结局
Transcriptional changes in gut microbiota
时间窗: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
16S rRNA gene sequencing will be performed with stander procedure
次要结局
- Epigenetic changes(Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery)