NCT04304131
Completed
Not Applicable
Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Kyung Hee University Hospital at Gangdong
- Enrollment
- 1210
- Locations
- 8
- Primary Endpoint
- SDC2 methylation in stool DNA
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A study of colorectal cancer screening using stool DNA-based SDC2 methylation test
Investigators
Suk-Hwan Lee
Professor
Kyung Hee University Hospital at Gangdong
Eligibility Criteria
Inclusion Criteria
- •Patient who agreed the clinical trial and signed informed consent
- •High risk patient for colorectal cancer (family history of colorectal cancer, history of adenomatous polyp excision, inflammatory bowel disease \> 15 years, or history of hereditary colorectal cancer)
- •Patient who scheduled to receive colonoscopy
- •Stool \> 20g before bowel preparation for colonoscopy
Exclusion Criteria
- •No high risk patient under 60 years
- •History of colorectal cancer
- •Stool \< 20g or sample after bowel preparation
- •Diarrhea or liquid stool which cannot be evaluated
- •Patient who is judged as not suitable for clinical trial including a psychiatric disorder by a physician
Outcomes
Primary Outcomes
SDC2 methylation in stool DNA
Time Frame: 1 year
positive ratio of SDC2 methylation
sensitivity and specificity of EarlyTect
Time Frame: 1 year
Study Sites (8)
Loading locations...
Similar Trials
Completed
Not Applicable
A Stool DNA Test for Detection of Advanced Colorectal Neoplasia in Asymptomatic Chinese Community PopulationColorectal CancerColorectal NeoplasmAdvanced AdenomaAdenomaSerrated LesionNCT04786704Changhai Hospital12,106
Unknown
Not Applicable
Fecal DNA Methylation Test for Colorectal Cancer ScreeningColorectal CancerColorectal AdenomaNCT04823793Tri-Service General Hospital80
Not yet recruiting
Not Applicable
DYNAMICS-LYNCH：DNA Methylation Analysis in Stool for Screening of Lynch Syndrome-Associated Colorectal CancerColorectal Cancer ScreeningLynch SyndromeNCT06772844Sun Yat-sen University400
Unknown
Not Applicable
Stool-based SDC2 DNA Methylation Test for the Detection of Colorectal Advanced Adenomatous Polyps and CancerColorectal CancerColorectal Adenomatous PolypScreeningNCT04221854Sixth Affiliated Hospital, Sun Yat-sen University50,000
Completed
Not Applicable
Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer DetectionColorectal CancerPolypsOther CancersHealthyNCT03146520Genomictree, Inc.634