Colon Polyp, Colorectal Cancer, Healthy
Conditions
Brief summary
A study of colorectal cancer screening using stool DNA-based SDC2 methylation test
Interventions
DIAGNOSTIC_TESTEarlytect Colon Cancer
A diagnostic device measuring syndecan 2 methylation status in stool DNA to detect colorectal cancer
Sponsors
Genomictree, Inc.
Kyung Hee University Hospital at Gangdong
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SDC2 methylation in stool DNA | 1 year | positive ratio of SDC2 methylation |
| sensitivity and specificity of EarlyTect | 1 year | — |
Countries
South Korea
Outcome results
None listed