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| Name | Class |
|---|---|
| Genomictree, Inc. | INDUSTRY |
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A study of colorectal cancer screening using stool DNA-based SDC2 methylation test
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colorectal cancer | Experimental | Confirmed colorectal cancer under colonoscopy |
|
| Colon polyp | Experimental | Confirmed colorectal polyp under colonoscopy |
|
| Healthy | Active Comparator | Confirmed no cancer nor polyp under colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Earlytect Colon Cancer | Diagnostic Test | A diagnostic device measuring syndecan 2 methylation status in stool DNA to detect colorectal cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| SDC2 methylation in stool DNA | positive ratio of SDC2 methylation | 1 year |
| sensitivity and specificity of EarlyTect | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suk-Hwan Lee, MD, PhD | Kyung Hee University Hospital at Gangdong | Principal Investigator |
| Chang Woo Kim, MD, PhD | Ajou University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Busan Hangun Hospital | Busan | South Korea | ||||
| Koo Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21296855 | Result | 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. | |
| 16491070 | Result | 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Daegu |
| South Korea |
| Severance Hospital, Yonsei University College of Medicine | Seoul | 03722 | South Korea |
| Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine | Seoul | 05278 | 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 | 16247 | South Korea |
| 15719030 | Result | 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. |
| 12671664 | Result | Laird PW. The power and the promise of DNA methylation markers. Nat Rev Cancer. 2003 Apr;3(4):253-66. doi: 10.1038/nrc1045. |
| 23747112 | Result | 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. |
| 26565661 | Result | 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. |
| 25221563 | Result | 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. |
| 29225717 | Result | 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. |
| 30876480 | Result | 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. |
| 39292188 | Derived | 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. |
| 33858326 | Derived | 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. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |