Spots Global Cancer Trial Database for Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection
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Trial Identification
Brief Title: Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection
Official Title: Clinical Study for the Validation of Real Time qPCR for SDC2 Methylation in Stool DNA for Early Detection of Colorectal Cancer
Study ID: NCT03146520
Interventions
Study Description
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.
Eligibility
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Severance Hospital, Seoul, , Korea, Republic of
Contact Details
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