Clinical trial · Interventional
Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test
NCT04304131CI-TRIAL-00064666completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study of colorectal cancer screening using stool DNA-based SDC2 methylation test
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Polyp | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Earlytect Colon Cancer | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Colorectal cancer
- description
- Confirmed colorectal cancer under colonoscopy
- interventionNames
- Diagnostic Test: Earlytect Colon Cancer
- type
- EXPERIMENTAL
- label
- Colon polyp
- description
- Confirmed colorectal polyp under colonoscopy
- interventionNames
- Diagnostic Test: Earlytect Colon Cancer
- type
- ACTIVE_COMPARATOR
- label
- Healthy
- description
- Confirmed no cancer nor polyp under colonoscopy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
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
References
Publications (11)
- RESULTJemal 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. PMID 21296855
- RESULTBaylin 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. PMID 16491070
- RESULTUshijima T. Detection and interpretation of altered methylation patterns in cancer cells. Nat Rev Cancer. 2005 Mar;5(3):223-31. doi: 10.1038/nrc1571. PMID 15719030
- RESULTLaird PW. The power and the promise of DNA methylation markers. Nat Rev Cancer. 2003 Apr;3(4):253-66. doi: 10.1038/nrc1045. PMID 12671664
- RESULTOh 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. PMID 23747112
- RESULTXue 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. PMID 26565661
- RESULTMansour 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. PMID 25221563
- RESULTOh 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.