Multi-center Application Study of Quantitative FIT Technology for Colorectal Cancer Screening in Chinese Physical Examination Population
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500,000
- 试验地点
- 1
- 主要终点
- Sensitivity of quantitative FIT
研究概览
简要总结
In order to control the incidence of colorectal cancer, improve the level of early diagnosis and early warning the occurrence of colorectal cancer, it is very necessary for us to explore the threshold value of FIT positive judgment in line with the Chinese population, and further contribute to the establishment of a colorectal cancer screening pathway suitable for Chinese healthy population
详细描述
Feces were collected for quantitative FIT test. Those with positive results were further examined by colonoscopy. By comparing with pathological results of colonoscopy, the sensitivity, specificity, positive predictive value and negative predictive value of quantitative FIT technology for the diagnosis of colorectal tumors were confirmed.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy people aged 30 years and planning to undergo colonoscopy;
- •No history of gastrointestinal tumor;
- •No ulcerative colitis or Crohn's disease;
- •No gastrointestinal hemorrhagic disease;
- •No history of gastrointestinal surgery, able to understand and willing to sign informed consent.
排除标准
- •Other serious diseases of the digestive tract, such as Crohn's disease ulcerative colitis;
- •Patients with gastric and esophageal cancer and other malignant tumors;
- •Unable to cooperate after communication;
- •Subjects who have received radiotherapy and chemotherapy;
- •Other researchers believe that they are not suitable for inclusion in this clinical trial, such as mental illness patients, critical patients, pregnant women, illiterate minors, cognitive impairment PI, students of the researcher, PI, affiliated research units of the co-investigator or employees of the sponsor, etc
结局指标
主要结局
Sensitivity of quantitative FIT
时间窗: 1year
The sensitivity of quantitative FIT application in Chinese physical examination population
Specificity of quantitative FIT
时间窗: 1year
The specificity of quantitative FIT application in Chinese physical examination population
次要结局
未报告次要终点