Healthy Clinical Trial
Official title:
Clinical Study for the Validation of Real Time qPCR for SDC2 Methylation in Stool DNA for Early Detection of Colorectal Cancer
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. ;
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