A Multicenter Clinical Trial for the Comparison Among Fecal Immunochemical Test, Stool DNA Test and Blood mRNA Test in Chinese Colorectal Cancer Screening
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 3
- 主要终点
- Sensitivity and Specificity of Multiple Screening Methods With Comparison to Colonoscopy, Both With Respect to Cancer.
研究概览
简要总结
The primary objective is to determine the sensitivity and specificity of two Colorectal Cancer (CRC) screening methods, including stool DNA test and blood mRNA test, for colorectal cancer in Chinese population, with colonoscopy as reference method. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
The secondary objective is to compare the performance of these two CRC screening methods to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
详细描述
Participants who are at high risk of developing colorectal cancer will be asked to collect two stool samples one for the stool DNA test and the other for the commercially available FIT assay, and a single blood sample for the blood mRNA test. Subjects will undergo colonoscopy within 6 months of enrollment. Representative histopathology slides from tissue biopsied or excised during colonoscopy and those from subsequent definitive surgery may be retrieved in order to be evaluated by pathologists to confirm the diagnosis and staging.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects received screening questionnaire and had been defined as high risk.
- •Subjects haven't received any treatment under colonoscopy within 10 years.
排除标准
- •Subjects are under the usage of specific drugs which might affect the screening test.
- •Subjects had the contraindication for colonoscopy.
结局指标
主要结局
Sensitivity and Specificity of Multiple Screening Methods With Comparison to Colonoscopy, Both With Respect to Cancer.
时间窗: 6 months
次要结局
未报告次要终点
研究者
Hongzhi Zou
Principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University