Ultra-sensitivity Quantitative Fecal Immunochemical Test Improve Diagnostic Accuracy in Detecting Colorectal Advanced Adenoma and Colorectal Cancer: a Multicenter, Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6,000
- 试验地点
- 6
- 主要终点
- The accuracy of us-qFIT to diagnose colorectal advanced adenoma.
研究概览
简要总结
Early detecting and removing of colorectal advanced adenomas can reduce the incidence of colorectal cancer. Because of the less bleeding of advanced adenomas, sensitivities of the common used quantitative fecal immunochemical tests (qFITs) are unsatisfying. Ultra-sensitivity qFIT(us-qFIT) can determine extremely low fecal hemoglobin concentration compared with the common used qFIT. This study will prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenomas.
详细描述
Early detection of CRC in a curable stage can reduce mortality but not morbidity. The majority of colorectal cancer is thought to arise from precancerous lesions through the adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. Although colonoscopy is currently considered the most effective method for detecting advanced adenomas, individuals may be reluctant to undergo colonoscopy due to the uncomfortable feeling and the relatively high cost. Conversely, stool tests are relatively cheap and more readily accepted. Fecal immunochemical test (FIT) is economic and easy to use in colorectal cancer screening. However, the common used qFIT is insufficiently sensitive to the minor hemorrhage of advanced adenomas, and the sensitivity is about only 27% to 47%. To improve the detection rate of colorectal advanced adenoma, Ultra-sensitivity quantitative fecal immunochemical test (us-qFIT) improves technology and can detect fecal hemoglobin in extremely low concentration quantificationally. The investigators design this research to prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50-75 years old people;
- •People sign an "informed consent form"
排除标准
- •People with history of colorectal surgery;
- •People with history of colorectal cancer;
- •People with history of other diseases that may produce fecal blood, such as inflammatory bowel disease, ischemic enteritis, vascular alformation of intestine, intestinal tuberculosis or Non-Hodgkin's lymphoma involving digestive tract;
- •People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and watery stool;
- •People are in pregnancy, lactation or menstrual phase;
- •People with severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.
结局指标
主要结局
The accuracy of us-qFIT to diagnose colorectal advanced adenoma.
时间窗: 24 months
The sensitivity, specificity, positive predictive value and negative predictive value.
次要结局
- The accuracy of us-qFIT to diagnose colorectal cancer.(24 months)
- The accuracy of us-qFIT to diagnose high-risk adenoma.(24 months)
- Develop a predictive model of advanced colorectal neoplasms which includes the value of us-qFIT.(24 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University