Clinical trial · Observational
Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection
Clinical Study for the Validation of Real Time qPCR for SDC2 Methylation in Stool DNA for Early Detection of Colorectal Cancer
NCT03146520CI-TRIAL-00032562completedClinicalTrials.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)
Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical sensitivity and specificity in detection of colorectal cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Healthy | — | UNRESOLVED | — |
| Other Cancers | — | UNRESOLVED | — |
| Polyps | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EarlyTect Colon Cancer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Colorectal (CRC)
- description
- stage I-IV CRC subjects
- interventionNames
- Device: EarlyTect Colon Cancer
- label
- Polyps
- description
- subjects with adenoma or polyps
- interventionNames
- Device: EarlyTect Colon Cancer
- label
- Other cancers
- description
- subjects with other cancers
- interventionNames
- Device: EarlyTect Colon Cancer
- label
- Healthy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion criteria: * sample information is complete, including sample number, gender, family history, stage of cancer, treatment history, and other disease information * the CRC patient who has not any treatment (surgery, chemotherapy, or radiation) * non-CRC patient who has not received any treatment (surgery, chemotherapy, or radiation) within the last 6 months * all of above conditions are satisfied, and any one of below can be applicable; 1) confirm to be CRC with colonoscopy and/or pathological examination, 2) confirm to be inflammatory or ulcerative bowel diseases or benign hyperplastic polyp, 3) confirm to be gastrointestinal or liver cancers who are not CRC, 4) schedule to receive colonoscopy and additional confirmation test for CRC with agreement to provide the test results. Exclusion criteria: any one of below can be applicable; * the patient information is not complete and/or does not satisfy inclusion criteria * the sample information is not complete and/or does not satisfy inclusion criteria * the CRC patient who has history of colorectal cancer surgery, chemotherapy, or any other treatment * non-CRC patient who received any chemotherapy within the last 6 months * the patient who has limited ability or are vulnerable to accept clinical trial agreement * the patient who is judged as not suitable for clinical trial including a psychiatric disorder by a physician
References
Publications (2)
- BACKGROUNDOh 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
- DERIVEDHan 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. PMID 30876480