Evaluation of a Point-of-care Testing Instrument for Fecal Immunochemical Test
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Diagnostic performance of advanced neoplasms
研究概览
简要总结
Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer.Use of the fecal immunochemical test (FIT) for colorectal cancer (CRC) prevention is supported by previous studies.However existing instruments have low portability.The purpose of this study is to test the performance of a Point-of-care testing instrument for fecal Immunochemical test(FIT) .
详细描述
Colorectal cancer (CRC) is the third most common cancer worldwide and has become a progressively important public health problem that inevitably leads to an increase in morbidity and medical costs. Therefore, many countries have a screening program in place to lower the incidence of CRC. Subjects with a positive fecal immunochemical test (FIT) have a much higher likelihood of advanced neoplasms than the general population.However existing instruments have low portability.The purpose of this study is to test the performance of a Point-of-care testing instrument for fecal immunochemical test (FIT).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People who use the new instrument for fecal immunochemical test(FIT)
- •People sign an "informed consent form"
排除标准
- •People with history of surgery in any part of the large bowel;
- •People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and 7th type stool (Bristol feces score);
结局指标
主要结局
Diagnostic performance of advanced neoplasms
时间窗: 4 months
The study is committed to test the diagnostic efficacy of the new instrument to advanced neoplasms.We will measure the sensitivity and specificity of the instrument
次要结局
- Diagnostic performance of Colorectal Cancer(4 months)
研究者
Yanqing Li
Clinical Professor
Shandong University