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Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection

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

Clinical Trial Summary

Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical sensitivity and specificity in detection of colorectal cancer.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03146520
Study type Observational
Source Genomictree, Inc.
Contact
Status Completed
Phase
Start date December 13, 2016
Completion date March 30, 2018
View Details
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