Clinical trial · Interventional
Stool-based SDC2 DNA Methylation Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
Stool-based SDC2 DNA Methylation Test vs. Fecal Immunochemical Test on the Detection of Colorectal Advanced Adenomatous Polyps and Cancer in Chinese Population: A Multi-central Randomized Clinical Trial
- 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 is to compare the performance of Stool-based SDC2 DNA Methylation Test and commercially available Fecal Immunochemical Test(FIT) , on the detection rate of advanced adenomatous polyps and colorectal cancer in Chinese population. Subjects with positive results in either test will receive colonoscopy. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
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 |
|---|---|---|---|
| Colorectal Adenomatous Polyp | Colorectal Adenomatous Polyp | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Screening | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fecal immunochemical test | Diagnostic Test | — | UNRESOLVED |
| Stool-based SDC2 DNA methylation test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stool-based SDC2 DNA methylation test group
- description
- Subjects will received the stool-based SDC2 DNA methylation test for the screening of colorectal advanced adenomatous polyps and cancer.
- interventionNames
- Diagnostic Test: Stool-based SDC2 DNA methylation test
- type
- ACTIVE_COMPARATOR
- label
- Fecal immunochemical test group
- description
- Subjects will received the fecal immunochemical test for the screening of colorectal advanced adenomatous polyps and cancer.
- interventionNames
- Diagnostic Test: Fecal immunochemical test
Primary outcomes (1)
- measure
- The Detection Rate of Colorectal Polyps, Advanced Adenomatous Polyps and Cancer by Two Screening Methods
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is average risk for development of colorectal cancer. 2. Subject is able and willing to undergo a screening colonoscopy within six months of enrollment. 3. Subject is 45 to 80 years of age inclusive. 4. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study. 5. Subject is able and willing to provide stool samples according to written instructions provided to them. Exclusion Criteria: 1. Subject has any condition which, in the opinion of the investigator should preclude participation in the study. 2. Subject has a history of colorectal cancer or adenoma. 3. Subject has a history of other digestive tract cancer.
References
Publications (1)
- DERIVEDChen Y, Li J, Gu K, Ding K, Qin P, Pei Z, Gong Y, Xu D, Liang Y, Yang D, Dou J, Huang Y, Hu J, Wu P, Zhang S, Wang W, Shi L, Liu Q, Li C, Li W, Wang X, Lan P, Liang B, He X. Stool-based methylated syndecan-2 test and fecal immunochemical test for advanced colorectal neoplasia screening in the Chinese population: A multicenter randomized noncomparative study. Chin Med J (Engl). 2025 Dec 3. doi: 10.1097/CM9.0000000000003897. Online ahead of print. PMID 41334638