Clinical trial · Observational
A Stool DNA-based SDC2 Methylation Test for the Early Detection of Colorectal Cancer
A Multicenter, Single-blind, Prospective Clinical Trial to Evaluate the Clinical Performance of EarlyTect® CRC Test for the Early Detection of Colorectal Cancer in the Stool DNA From High-risk Group
NCT05255588CI-TRIAL-00088068completedClinicalTrials.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)
The primary objective of this clinical trial is to determine the sensitivity and specificity of the EarlyTect® CRC test for detecting CRC, using colonoscopy as the reference method. The secondary objective is to compare the clinical performance of EarlyTect® CRC test with a commercially available Fecal Immunochemical Test (FIT), with respect to CRC. By histopathological examination, lesions identified during colonoscopy will be confirmed as malignant or precancerous by histological examination.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Adenomas | Adenoma | CURATED_BROADER | 0.78 |
| Advanced Colorectal Neoplasm | Colorectal Neoplasm | CURATED_BROADER | 0.78 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non-advanced Adenomas | — | UNRESOLVED | — |
| Non-neoplastic Polyps | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EarlyTect® CRC test | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cohort
- description
- Subjects who are at high-risk (Asia Pacific Colorectal Screening Score ≥4.0) of developing CRC aged ≥40
- interventionNames
- Device: EarlyTect® CRC test
Primary outcomes (1)
- measure
- Sensitivity and specificity of the EarlyTect® CRC test for detecting CRC compared to the colonoscopy, both in terms of detecting CRC.
- timeFrame
- 18 months
- description
- The reference method is the colonoscopy, and lesions will be assessed histopathologically. EarlyTect® CRC test includes a measurement of SDC2 methylation and COL2A1 as a DNA control. SDC2 methylation in stool DNA will be assessed quantitatively by LTE/qMSP. The results will be dichotomized by the CT (cycle threshold) cutoff value as either positive or negative. Sensitivity = 100\*(positive SDC2 methylation test/positive colonoscopy), Specificity = 100\*(negative SDC2 methylation test/negative colonoscopy).
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: Subjects enrolled into the study must meet the following criteria: * Individuals who agree to voluntarily sign an informed consent prior to the initiation of screening * Adults aged ≥ 40 years * Subjects who are at high-risk (Asia Pacific Colorectal Screening (APCS) Score: 4.0\~7.0) of developing CRC * Subjects who are able and willing to undergo colonoscopy screening within 12 months of consent among individuals who reserved a visit in the division of gastroenterology or health check-up. Exclusion Criteria: Subjects will be excluded from enrolling into the study if any of the following criteria are met: * Individuals who do not agree to voluntarily sign an informed consent prior to the initiation of screening * Adults aged \< 40 years * Subjects who are not at high-risk (APCS Score ≤ 3.0) of developing CRC * Subjects who will not undergo colonoscopy screening within 12 months of consent * Subjects who have had a positive FIT or fecal occult blood test within the previous 2 weeks * Colorectal cancer patients who did not underwent curative treatment * Subjects who have had a prior history of colorectal resection * Subjects who have had overt rectal bleeding or melena within the previous 2 weeks * Subjects who have a family history or a prior history of hereditary CRC or colorectal neoplasm: Lynch syndrome (HNPCC), familial adenomatous polyposis, MUTYH-associated polyposis, Juvenile polyposis syndrome, Peutz-Jeghers syndrome, and serrated polyposis syndrome, etc. * Subjects who have inflammatory bowel diseases including Crohn's disease, ulcerative colitis or Behcet disease * Subjects who participated in any "interventional" clinical study within the previous 30 days * Subject has any condition which, in the opinion of the medical staff should preclude participation in the study
References
Publications (2)
- BACKGROUNDOh 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. PMID 29225717
- BACKGROUNDHan 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