Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
Not Applicable
Completed
- Conditions
- HealthyColorectal CancerColon Polyp
- Registration Number
- NCT04304131
- Lead Sponsor
- Kyung Hee University Hospital at Gangdong
- Brief Summary
A study of colorectal cancer screening using stool DNA-based SDC2 methylation test
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1210
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method SDC2 methylation in stool DNA 1 year positive ratio of SDC2 methylation
sensitivity and specificity of EarlyTect 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Busan Hangun Hospital
🇰🇷Busan, Korea, Republic of
Koo Hospital
🇰🇷Daegu, Korea, Republic of
Severance Hospital, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine
🇰🇷Seoul, Korea, Republic of
Dea Hang Hospital
🇰🇷Seoul, Korea, Republic of
Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Seoul Songdo Hospital
🇰🇷Seoul, Korea, Republic of
St. Vincent's Hospital, The Catholic University of Korea
🇰🇷Suwon, Korea, Republic of
Busan Hangun Hospital🇰🇷Busan, Korea, Republic of