A Comparison of Quantitative Fecal Immunochemical Test and Qualitative Fecal Occult Blood Test for Colorectal Cancer Screening in Medium and High Risk Screening Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The accuracy of 4 kind of FOBTs to diagnose CRC.
研究概览
简要总结
Colorectal cancer is a leading cause of cancer-related morbidity and mortality. CRC-related death can be prevented through fecal occult blood test screening. Because of economic and high sensitivity, fecal immunochemical test is recommended for screening population of CRC. The purpose of this study is to compare the accuracy of 4 different fecal occult blood testing in medium and high risk screening population in Chinese.
详细描述
Colorectal cancer (CRC) is one of the most common cancer worldwide, and cause a huge number of cancer-associated mortality. CRC screening has been shown to be effective in reducing the incidence of, and mortality from, CRC. There are several recommended screening options for screening population of CRC, including colonoscopy and fecal occult blood testing (FOBT) .Colonoscopy has higher sensitivity and specificity than FOBT for detecting advanced colorectal neoplasia but also has several disadvantages, including higher cost and poorer compliance. Therefore, many patients prefer FOBT to colonoscopy. FOBT includes guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT). FIT includes quantitative FIT (qFIT) and qualitative FIT. qFIT can provide a value of concentration of hemoglobin in stool and are increasingly recommended for CRC. In China, the most common use FOBT is qualitative FIT and the comparison of quantitative and qualitative FIT is lack in screening population of CRC in Chinese. To add to the evidence on FIT performance characteristics for detection of CRC, the investigators design this research to compare qFIT with other 3 qualitative FOBT（two of them are colloidal gold qualitative FITs and one of them is chemical and immunologic combined detection）in medium and high risk screening population.
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
- •Adults 50-75 years old;
- •Asia-Pacific Colorectal Screening score(APCS): medium or high risk.
排除标准
- •APCS score: low risk;
- •People with history of intestinal surgery;
- •People with history of CRC;
- •People with history of inflammatory bowel disease, ischemic enteritis, vascular malformation of intestine or other disease resulting in intestinal tract bleeding;
- •People with symptoms including visible rectal bleeding, hematuria, severe and acute diarrhea and Bristol feces score 7th type;
- •Pregnancy, lactation or menstrual phase;
- •Severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.
结局指标
主要结局
The accuracy of 4 kind of FOBTs to diagnose CRC.
时间窗: 6 months
The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect CRC.
The accuracy of 4 kind of FOBTs to diagnose advanced colorectal neoplasm.
时间窗: 6 months
The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced colorectal neoplasm.
Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT.
时间窗: 6 months
Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT, age ,sex, CRC family history and so on.
The accuracy of 4 kind of FOBTs to diagnose advanced adenoma.
时间窗: 6 months
The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced adenoma.
次要结局
- Explore the reason of false positive of qFIT(6 month)
- Explore the cost-benefit ratio of one or two-sample of qFIT.(6 month)
- Explore the effect of aspirin or other anticoagulants to the diagnose accuracy of qFIT(6 month)
研究者
Yanqing Li
Clinical Professor
Shandong University