Back to resultsColorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
Primary Purpose
Colorectal Cancer, Colon Polyp, Healthy
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Earlytect Colon Cancer
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer
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
Sites / Locations
- Busan Hangun Hospital
- Koo Hospital
- Severance Hospital, Yonsei University College of Medicine
- Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine
- Dea Hang Hospital
- Eunpyeong St. Mary's Hospital
- Seoul Songdo Hospital
- St. Vincent's Hospital, The Catholic University of Korea
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Colorectal cancer
Colon polyp
Healthy
Arm Description
Confirmed colorectal cancer under colonoscopy
Confirmed colorectal polyp under colonoscopy
Confirmed no cancer nor polyp under colonoscopy
Outcomes
Primary Outcome Measures
SDC2 methylation in stool DNA
positive ratio of SDC2 methylation
sensitivity and specificity of EarlyTect
Secondary Outcome Measures
Full Information
NCT ID
NCT04304131
First Posted
March 9, 2020
Last Updated
March 12, 2023
Sponsor
Kyung Hee University Hospital at Gangdong
Collaborators
Genomictree, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04304131
Brief Title
Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
Official Title
Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 7, 2020 (Actual)
Primary Completion Date
January 10, 2022 (Actual)
Study Completion Date
January 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyung Hee University Hospital at Gangdong
Collaborators
Genomictree, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A study of colorectal cancer screening using stool DNA-based SDC2 methylation test
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colon Polyp, Healthy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colorectal cancer
Arm Type
Experimental
Arm Description
Confirmed colorectal cancer under colonoscopy
Arm Title
Colon polyp
Arm Type
Experimental
Arm Description
Confirmed colorectal polyp under colonoscopy
Arm Title
Healthy
Arm Type
Active Comparator
Arm Description
Confirmed no cancer nor polyp under colonoscopy
Intervention Type
Diagnostic Test
Intervention Name(s)
Earlytect Colon Cancer
Intervention Description
A diagnostic device measuring syndecan 2 methylation status in stool DNA to detect colorectal cancer
Primary Outcome Measure Information:
Title
SDC2 methylation in stool DNA
Description
positive ratio of SDC2 methylation
Time Frame
1 year
Title
sensitivity and specificity of EarlyTect
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suk-Hwan Lee, MD, PhD
Organizational Affiliation
Kyung Hee University Hospital at Gangdong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chang Woo Kim, MD, PhD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Busan Hangun Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Koo Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Facility Name
Dea Hang Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Eunpyeong St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Songdo Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
St. Vincent's Hospital, The Catholic University of Korea
City
Suwon
ZIP/Postal Code
16247
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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21296855
Citation
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Citation
Ushijima T. Detection and interpretation of altered methylation patterns in cancer cells. Nat Rev Cancer. 2005 Mar;5(3):223-31. doi: 10.1038/nrc1571.
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Citation
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Results Reference
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PubMed Identifier
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Citation
Oh T, Kim N, Moon Y, Kim MS, Hoehn BD, Park CH, Kim TS, Kim NK, Chung HC, An S. Genome-wide identification and validation of a novel methylation biomarker, SDC2, for blood-based detection of colorectal cancer. J Mol Diagn. 2013 Jul;15(4):498-507. doi: 10.1016/j.jmoldx.2013.03.004. Epub 2013 Jun 7.
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Citation
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Citation
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Citation
Oh TJ, Oh HI, Seo YY, Jeong D, Kim C, Kang HW, Han YD, Chung HC, Kim NK, An S. Feasibility of quantifying SDC2 methylation in stool DNA for early detection of colorectal cancer. Clin Epigenetics. 2017 Dec 4;9:126. doi: 10.1186/s13148-017-0426-3. eCollection 2017.
Results Reference
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PubMed Identifier
30876480
Citation
Han YD, Oh TJ, Chung TH, Jang HW, Kim YN, An S, Kim NK. Early detection of colorectal cancer based on presence of methylated syndecan-2 (SDC2) in stool DNA. Clin Epigenetics. 2019 Mar 15;11(1):51. doi: 10.1186/s13148-019-0642-0.
Results Reference
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PubMed Identifier
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Citation
Kim CW, Kim H, Kim HR, Kye BH, Kim HJ, Min BS, Oh TJ, An S, Lee SH. Colorectal cancer screening using a stool DNA-based SDC2 methylation test: a multicenter, prospective trial. BMC Gastroenterol. 2021 Apr 15;21(1):173. doi: 10.1186/s12876-021-01759-9.
Results Reference
derived
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Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
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