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

Completed

• Conditions: Colorectal Cancer; Healthy; Other Cancers; Polyps
• Interventions: Device: EarlyTect Colon Cancer

• 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.

Study Timeline

• Study Start: 2016-12-13
• Study First Submitted: 2017-05-07
• Study First Submitted QC: 2017-05-07
• Study First Posted: 2017-05-10
• Primary Completion: 2018-03-18
• Study Completion: 2018-03-30
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 634

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colorectal (CRC)	EarlyTect Colon Cancer	stage I-IV CRC subjects
Polyps	EarlyTect Colon Cancer	subjects with adenoma or polyps
Healthy	EarlyTect Colon Cancer	subjects with no evidence of CRC
Other cancers	EarlyTect Colon Cancer	subjects with other cancers

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