Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
NCT ID: NCT04304131
Last Updated: 2023-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1210 participants
INTERVENTIONAL
2020-06-07
2022-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Colorectal cancer
Confirmed colorectal cancer under colonoscopy
Earlytect Colon Cancer
A diagnostic device measuring syndecan 2 methylation status in stool DNA to detect colorectal cancer
Colon polyp
Confirmed colorectal polyp under colonoscopy
Earlytect Colon Cancer
A diagnostic device measuring syndecan 2 methylation status in stool DNA to detect colorectal cancer
Healthy
Confirmed no cancer nor polyp under colonoscopy
Earlytect Colon Cancer
A diagnostic device measuring syndecan 2 methylation status in stool DNA to detect colorectal cancer
Interventions
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Earlytect Colon Cancer
A diagnostic device measuring syndecan 2 methylation status in stool DNA to detect colorectal cancer
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Genomictree, Inc.
INDUSTRY
Kyung Hee University Hospital at Gangdong
OTHER
Responsible Party
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Suk-Hwan Lee
Professor
Principal Investigators
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Suk-Hwan Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyung Hee University Hospital at Gangdong
Chang Woo Kim, MD, PhD
Role: STUDY_DIRECTOR
Ajou University School of Medicine
Locations
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Busan Hangun Hospital
Busan, , South Korea
Koo Hospital
Daegu, , South Korea
Severance Hospital, Yonsei University College of Medicine
Seoul, , South Korea
Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine
Seoul, , South Korea
Dea Hang Hospital
Seoul, , South Korea
Eunpyeong St. Mary's Hospital
Seoul, , South Korea
Seoul Songdo Hospital
Seoul, , South Korea
St. Vincent's Hospital, The Catholic University of Korea
Suwon, , South Korea
Countries
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References
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Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
Baylin SB, Ohm JE. Epigenetic gene silencing in cancer - a mechanism for early oncogenic pathway addiction? Nat Rev Cancer. 2006 Feb;6(2):107-16. doi: 10.1038/nrc1799.
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.
Laird PW. The power and the promise of DNA methylation markers. Nat Rev Cancer. 2003 Apr;3(4):253-66. doi: 10.1038/nrc1045.
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.
Xue M, Lai SC, Xu ZP, Wang LJ. Noninvasive DNA methylation biomarkers in colorectal cancer: A systematic review. J Dig Dis. 2015 Dec;16(12):699-712. doi: 10.1111/1751-2980.12299.
Mansour H. Cell-free nucleic acids as noninvasive biomarkers for colorectal cancer detection. Front Genet. 2014 Aug 27;5:182. doi: 10.3389/fgene.2014.00182. eCollection 2014.
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.
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.
Kim CW, Kim H, Kim HR, Won DD, Nam WJ, Min BS, Oh TJ, An S, Lee SH. A Stool DNA-Based SDC2 Methylation Test for the Early Detection of Colorectal Cancer in an Asymptomatic, High-Risk Population: A Multicenter Prospective Randomized Trial. Am J Gastroenterol. 2025 Mar 1;120(3):614-622. doi: 10.14309/ajg.0000000000003044. Epub 2024 Aug 21.
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.
Other Identifiers
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Earlytect
Identifier Type: -
Identifier Source: org_study_id
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