Pilot Study for Colorectal Cancer and Advanced Adenoma Detection With the Mainz Biomed Colorectal Cancer Test (eAArly DETECT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mainz Biomed
- 入组人数
- 2,700
- 试验地点
- 1
- 主要终点
- Feasibility, test optimization, algorithm, and cut off ranges for the Mainz Biomed Colorectal Cancer Screening Test.
研究概览
简要总结
The Mainz Biomed Colorectal Cancer Screening Test is being studied for its performance in the identification of the presence of colorectal cancer (CRC) or advanced adenoma (AA) in the colon in patients at average risk for colorectal cancer.
详细描述
The primary objectives of this study are:
- Feasibility and test optimization for the Mainz Biomed Colorectal Cancer Screening Test.
- To develop the test algorithm and establish the clinical cut-off values for the Mainz Biomed Colorectal Cancer Screening Test.
Each enrolled participant will be asked to provide a stool sample. The stool sample will be shipped to a laboratory and tested. No results will be provided to the site or the participant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Feasibility, test optimization, algorithm, and cut off ranges for the Mainz Biomed Colorectal Cancer Screening Test.
时间窗: 3 years
Test results will be used for the feasibility, test optimization, algorithm, and cut- off ranges for the Mainz Biomed Colorectal Cancer Screening Test.
次要结局
未报告次要终点