Healthy Clinical Trial
Official title:
Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
| NCT number | NCT04304131 |
| Other study ID # | Earlytect |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 7, 2020 |
| Est. completion date | January 10, 2022 |
| Verified date | March 2023 |
| Source | Kyung Hee University Hospital at Gangdong |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A study of colorectal cancer screening using stool DNA-based SDC2 methylation test
| Status | Completed |
| Enrollment | 1210 |
| Est. completion date | January 10, 2022 |
| Est. primary completion date | January 10, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Busan Hangun Hospital | Busan | |
| Korea, Republic of | Koo Hospital | Daegu | |
| Korea, Republic of | Dea Hang Hospital | Seoul | |
| Korea, Republic of | Eunpyeong St. Mary's Hospital | Seoul | |
| Korea, Republic of | Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine | Seoul | |
| Korea, Republic of | Seoul Songdo Hospital | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University College of Medicine | Seoul | |
| Korea, Republic of | St. Vincent's Hospital, The Catholic University of Korea | Suwon |
| Lead Sponsor | Collaborator |
|---|---|
| Kyung Hee University Hospital at Gangdong | Genomictree, Inc. |
Korea, Republic of,
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. — View 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. — View Citation
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. Erratum In: CA Cancer J Clin. 2011 Mar-Apr;61(2):134. — View Citation
Laird PW. The power and the promise of DNA methylation markers. Nat Rev Cancer. 2003 Apr;3(4):253-66. doi: 10.1038/nrc1045. — View Citation
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. — View 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. — View 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. eCollecti — View 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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | SDC2 methylation in stool DNA | positive ratio of SDC2 methylation | 1 year | |
| Primary | sensitivity and specificity of EarlyTect | 1 year |
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