Stool-based SDC2 DNA Methylation Test vs. Fecal Immunochemical Test on the Detection of Colorectal Advanced Adenomatous Polyps and Cancer in Chinese Population: A Multi-central Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50,000
- 试验地点
- 8
- 主要终点
- The Detection Rate of Colorectal Polyps, Advanced Adenomatous Polyps and Cancer by Two Screening Methods
研究概览
简要总结
The primary objective is to compare the performance of Stool-based SDC2 DNA Methylation Test and commercially available Fecal Immunochemical Test(FIT) , on the detection rate of advanced adenomatous polyps and colorectal cancer in Chinese population. Subjects with positive results in either test will receive colonoscopy. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
详细描述
A large cohort of participants will be asked to collect stool sample for either Stool-based SDC2 DNA Methylation Test or Fecal Immunochemical Test. Subjects who have positive results will undergo colonoscopy within 6 months.
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
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •Subject is average risk for development of colorectal cancer.
- •Subject is able and willing to undergo a screening colonoscopy within six months of enrollment.
- •Subject is 45 to 80 years of age inclusive.
- •Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
- •Subject is able and willing to provide stool samples according to written instructions provided to them.
排除标准
- •Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
- •Subject has a history of colorectal cancer or adenoma.
- •Subject has a history of other digestive tract cancer.
结局指标
主要结局
The Detection Rate of Colorectal Polyps, Advanced Adenomatous Polyps and Cancer by Two Screening Methods
时间窗: One year
The stool-based SDC2 DNA methylation test CT values of 38 or less compared to beta-actin considered to be positive. Fecal immunochemical test values of more than 100 ng of hemoglobin per milliliter of buffer were considered as positive. An optical colonoscopy is used as diagnostic method. Lesions will be confirmed by histopathologic examination.
次要结局
未报告次要终点
研究者
Ping Lan
Professor
Sixth Affiliated Hospital, Sun Yat-sen University