NCT04304131CompletedNot Applicable
Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
Kyung Hee University Hospital at Gangdong11 sites in 1 country1,210 target enrollmentStarted: June 7, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,210
- Locations
- 11
- Primary Endpoint
- SDC2 methylation in stool DNA
Study Overview
Brief Summary
A study of colorectal cancer screening using stool DNA-based SDC2 methylation test
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
SDC2 methylation in stool DNA
Time Frame: 1 year
positive ratio of SDC2 methylation
sensitivity and specificity of EarlyTect
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Suk-Hwan Lee
Professor
Kyung Hee University Hospital at Gangdong
Study Sites (11)
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