Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
Not Applicable
Completed
- Conditions
- HealthyColorectal CancerColon Polyp
- Interventions
- Diagnostic Test: Earlytect Colon Cancer
- 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
- Arm && Interventions
Group Intervention Description Colon polyp Earlytect Colon Cancer Confirmed colorectal polyp under colonoscopy Colorectal cancer Earlytect Colon Cancer Confirmed colorectal cancer under colonoscopy Healthy Earlytect Colon Cancer Confirmed no cancer nor polyp under colonoscopy
- 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)
Koo Hospital
🇰🇷Daegu, Korea, Republic of
Busan Hangun Hospital
🇰🇷Busan, Korea, Republic of
Dea Hang Hospital
🇰🇷Seoul, 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
Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
St. Vincent's Hospital, The Catholic University of Korea
🇰🇷Suwon, Korea, Republic of
Seoul Songdo Hospital
🇰🇷Seoul, Korea, Republic of