NCT04304131已完成不适用
Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,210
- 试验地点
- 11
- 主要终点
- SDC2 methylation in stool DNA
研究概览
简要总结
A study of colorectal cancer screening using stool DNA-based SDC2 methylation test
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who agreed the clinical trial and signed informed consent
- •High risk patient for colorectal cancer (family history of colorectal cancer, history of adenomatous polyp excision, inflammatory bowel disease > 15 years, or history of hereditary colorectal cancer)
- •Patient who scheduled to receive colonoscopy
- •Stool > 20g before bowel preparation for colonoscopy
排除标准
- •No high risk patient under 60 years
- •History of colorectal cancer
- •Stool < 20g or sample after bowel preparation
- •Diarrhea or liquid stool which cannot be evaluated
- •Patient who is judged as not suitable for clinical trial including a psychiatric disorder by a physician
结局指标
主要结局
SDC2 methylation in stool DNA
时间窗: 1 year
positive ratio of SDC2 methylation
sensitivity and specificity of EarlyTect
时间窗: 1 year
次要结局
未报告次要终点
研究者
Suk-Hwan Lee
Professor
Kyung Hee University Hospital at Gangdong
研究点 (11)
Loading locations...
相似试验
已完成
不适用
A Stool DNA Test for Detection of Advanced Colorectal Neoplasia in Asymptomatic Chinese Community PopulationColorectal NeoplasmAdvanced AdenomaAdenomaSerrated LesionColorectal CancerNCT04786704Changhai Hospital12,106
Unknown
不适用
Fecal DNA Methylation Test for Colorectal Cancer ScreeningColorectal CancerColorectal AdenomaNCT04823793Tri-Service General Hospital80
尚未招募
不适用
DYNAMICS-LYNCH：DNA Methylation Analysis in Stool for Screening of Lynch Syndrome-Associated Colorectal CancerColorectal Cancer ScreeningLynch SyndromeNCT06772844Sun Yat-sen University400
Unknown
不适用
Stool-based SDC2 DNA Methylation Test for the Detection of Colorectal Advanced Adenomatous Polyps and CancerColorectal Adenomatous PolypScreeningColorectal CancerNCT04221854Sixth Affiliated Hospital, Sun Yat-sen University50,000
已完成
不适用
Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer DetectionPolypsOther CancersHealthyColorectal CancerNCT03146520Genomictree, Inc.634