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临床试验/NCT03667495
NCT03667495Unknown不适用

Postoperative Oral and Intestinal Flora Changes in Patients With Colorectal Cancer and the Relationship Between These Changes and Prognosis

First Affiliated Hospital of Harbin Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Colorectal cancer or adenoma recurred

研究概览

简要总结

Specific oral microbiome has been found to contribute to the development of colorectal cancer. We speculate that specific oral microbiota related to colorectal cancer relapse after curative treatment. This study aim to discover if any difference of oral 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

Colorectal cancer is a major cause of cancerrelated deaths and the third most commonly diagnosed cancer worldwide.Current estimates indicate that 20-30% of those who undergo treatment will experience recurrence and 35% of all patients will die within 5 years.

The human colon plays host to a diverse and metabolically complex community of microorganisms. While the specific oral microbiome has been found to contribute to the development of colorectal cancer. Investigators speculate that specific oral 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 oral 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. 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
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Requirements of informed consent and assent of participant, parent or legal guardian as applicable
  • Patients who underwent exhaustive colorectal cancer surgical resection and accept colonoscopy
  • Patients between the age of 35 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

Colorectal cancer or adenoma recurred

时间窗: 12 months after surgery

Use colonoscopy to check for recurrence of colorectal cancer

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital of Harbin Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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