Microbiome Test for the Detection of Colorectal Polyps
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- diagnose existence of colon polyps
研究概览
简要总结
The main goal of this trial is to validate a new method for colorectal polyp screening based on stool microbiome signatures. 600 Individuals who are scheduled / planned to undergo a colonoscopy will be recruited for this study and a stool sample and an optional saliva sample will be collected.
Analyze process will be conducted on the microbiome of the samples given.
详细描述
Colorectal cancer (CRC) is the second cause of cancer death in the US. The pathogenesis of CRC is complex, involving a progressive transition of the healthy colonic mucosa to pre-cancerous polyps, and eventually to CRC. One of the factors that are proposed to cause this 'adenoma-carcinoma sequence' is the dysbiosis of the gut microbiome.
The gut microbiota has been identified as a potential screening biomarker for CRC, since studies have reported specific bacterial taxa and/ or microbial signatures as important factors in the etiology of CRC.
Hypothesis:
comprehensive and cutting-edge metagenomic analysis of the fecal microbiome of individuals with colonic polyps vs. patients without polyps will identify microbial signatures associated with colonic polyps and will define these microbial signatures as biomarkers and risk factors for CRC.
method:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females.
- •Age: 45-70 years, inclusive.
- •Patients without any incapacitating systemic disease
- •Able to comprehend and provide informed consent.
- •Patients who are scheduled / planned to undergo a colonoscopy, preferably: participants who are undergoing a colonoscopy as a diagnostic surveillance.
排除标准
- •Subject has a history of colorectal cancer (CRC)
- •Subject has a diagnosis or medical history of any of the following conditions:
- •Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome)
- •Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome")
- •Subject has a diagnosis or personal history of inflammatory bowel disease (IBD), including chronic ulcerative colitis or Crohn's disease.
- •Patients with incapacitating systemic disease
- •Any use of antibiotics within one months prior to colonoscopy.
结局指标
主要结局
diagnose existence of colon polyps
时间窗: year
To determine whether fecal metagenomics microbial signatures can significantly predict adenoma\\ sessile serrated polyps (SSP) existence in patients and serve as diagnostic biomarkers.
次要结局
- Saliva microbiome vs stool microbiome(year)
- diagnose sub types of colon polyps(year)