Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical sensitivity and specificity in detection of colorectal cancer.
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.
Study Type
OBSERVATIONAL
Enrollment
634
SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit
Severance Hospital
Seoul, South Korea
Clinical performance of EarlyTect Colon Cancer to detect colorectal cancer
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)
Time frame: 1.5 years
Positive ratio of SDC2 methylation in polyps
the ratio of SDC2 methylation positive in polyps
Time frame: 1.5 years
Positive ratio of SDC2 methylation in other cancers
the ratio of SDC2 methylation positive in other cancers
Time frame: 1.5 years
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