Metabiomics Colon Cancer Clinical Research Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- False negative rate of test for colon cancer
研究概览
简要总结
The specific aim of the study is to determine the false negative rate of the Metabiomics Colon Polyp and Colorectal Cancer Assay for 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 case several types of gut microbiome samples will be collected from patients undergoing colectomy for colonic adenocarcinoma; those samples will be tested by Metabiomics Colon Polyp and Colorectal Cancer Assay and the percentage of false negative (test returns a negative for cancer) results determined.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recently diagnosed with colorectal cancer (CRC) and scheduled for colectomy
- •Male or female,
- •Age: 18-95 years,
- •Able to comprehend, sign, and date the written informed consent form (ICF),
- •Able to give informed consent in English
- •Women and minorities will be included.
排除标准
- •History of Inflammatory Bowel Disease
- •Antibiotics within 2 weeks of sample collection.
- •Colonoscopy, colon prep or bowel contrast agent within 7 days prior to sample collection
- •Any radiation therapy
结局指标
主要结局
False negative rate of test for colon cancer
时间窗: immediately post surgery
The False Negative Rate is calculated as (100\*False Negative) /(True Positive + False Negative).
次要结局
未报告次要终点