Trials / Completed
CompletedNCT03146520
Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection
Clinical Study for the Validation of Real Time qPCR for SDC2 Methylation in Stool DNA for Early Detection of Colorectal Cancer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 634 (actual)
- Sponsor
- Genomictree, Inc. · Industry
- Sex
- All
- Age
- 30 Years – 80 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EarlyTect Colon Cancer | SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit |
Timeline
- Start date
- 2016-12-13
- Primary completion
- 2018-03-18
- Completion
- 2018-03-30
- First posted
- 2017-05-10
- Last updated
- 2018-04-18
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03146520. Inclusion in this directory is not an endorsement.