Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection
- Conditions
- Colorectal CancerHealthyOther CancersPolyps
- Registration Number
- NCT03146520
- Lead Sponsor
- Genomictree, Inc.
- Brief Summary
Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical sensitivity and specificity in detection of colorectal cancer.
- Detailed Description
The purpose of this study is to validate the clinical performance of EarlyTect Colon Cancer test which is measuring Syndecan 2 methylation status in stool DNA to detect CRC. Syndecan 2 (SDC2) is a newly developed methylation biomarker for colorectal cancer diagnosis. Methylation status of SDC2 gene in stool DNA is determined by methylation specific qPCR. Sensitivity and specificity will be determined by comparing Stool DNA test from healthy subjects, CRC patients, and other group including polyps and other diseases.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 634
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical performance of EarlyTect Colon Cancer to detect colorectal cancer 1.5 years Sensitivity and specificity of EarlyTect Colon Cancer to detect colorectal cancer (sensitivity: the ratio of positive cases in all CRC cases, specificity: the ratio of negative cases in all healthy controls)
- Secondary Outcome Measures
Name Time Method Positive ratio of SDC2 methylation in other cancers 1.5 years the ratio of SDC2 methylation positive in other cancers
Positive ratio of SDC2 methylation in polyps 1.5 years the ratio of SDC2 methylation positive in polyps
Trial Locations
- Locations (1)
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital🇰🇷Seoul, Korea, Republic of