Metabiomics Neoplasia Clinical Research Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Performance of Metabiomics Colon Polyp and Colorectal Cancer Assay
研究概览
简要总结
The purpose if this study is to measure the sensitivity, specificity and accuracy of the Metabiomics Colon Polyp and Colorectal Cancer Assay for the non-invasive detection of colon polyps or colorectal cancer.
详细描述
The purpose of this study is to conduct clinical research to investigate the association of the gut microbiome with colonic neoplasia. In this study patients will supply samples of their gut microbiome prior to scheduled colonoscopy; the relative abundance of microbes from those samples will be used to predict the presence or absence of colon polyps or colorectal cancer. Microbiome based predictions from blinded samples will be compared with colonoscopy and pathology results to quantify the sensitivity, specificity and accuracy (reported as %) of the Metabiomics Colon Polyp and Colorectal Cancer Assay for colon polyps. The limited sample size is anticipated to be insufficient to quantify sensitivity to colorectal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female,
- •Age: 45-80 years,
- •Patients undergoing polyp surveillance or screening colonoscopy who are ASA Class 1-
- •No ASA Class 4 or 5 will be included.Footnote
- •All ethnic and racial groups will be included,
- •Able to comprehend, sign, and date the written informed consent form (ICF),
- •Able to give informed consent in English.
排除标准
- •History of Inflammatory Bowel Disease
- •Inability to schedule the colonoscopy within 60 days of the initial stool sample
- •Colonic pathology that in the opinion of the endoscopist could interfere with the accuracy of the colonoscopy. Examples include: colonic stricture, poor preparation, obstructing tumor.
- •ASA class 4 or greater
- •Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity.
结局指标
主要结局
Performance of Metabiomics Colon Polyp and Colorectal Cancer Assay
时间窗: 1 year
Microbiome based predictions from at least 100 blinded samples will be compared with colonoscopy and pathology results to quantify the sensitivity, specificity and accuracy (reported as %) of the Metabiomics Colon Polyp and Colorectal Cancer Assay for colon polyps. The limited sample size is anticipated to be insufficient to quantify sensitivity to colorectal cancer.
次要结局
未报告次要终点