Clinical trial · Observational
A Stool DNA Test for Detection of Advanced Colorectal Neoplasia in Asymptomatic Chinese Community Population
Detection of Advanced Colorectal Neoplasia for Stool DNA in Asymptomatic Chinese Population : A Multi-central Community-based Screening Study
NCT04786704CI-TRIAL-00059355completedClinicalTrials.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)
to determine screening value of stool-based SDC2 DNA methylation test for advanced colorectal neoplasia in the asymptomatic Chinese community population.
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 |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Advanced Adenoma | Adenoma | CURATED_BROADER | 0.78 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Serrated Lesion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quantitative Fecal immunochemical test | Diagnostic Test | — | UNRESOLVED |
| Stool-based SDC2 DNA methylation test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Detection of advanced colorectal neoplasia
- timeFrame
- Through study completion, an average of 1 year
- description
- Advanced colorectal neoplasia is defined as a colorectal adenoma or sessile serrated lesion ≥10 mm, adenoma or sessile serrated lesion with tubulovillous or villous histology, adenoma with high-grade dysplasia, traditional serrated adenoma, or presence of colorectal cancer.
Secondary outcomes (5)
- measure
- Compliance rate of colonoscopy
- timeFrame
- Through study completion, an average of 1 year
- description
- The compliance rate of colonoscopy was calculated as the number of recieving colonoscopy divdied the number of accomplishing primary evaluation of APCS, stool DNA or FIT.
- measure
- Detection of colorectal cancer
- timeFrame
- Through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Asymptomatic screening individual (no alarm features predicting colorectal cancer including hematochezia, melena, anemia of unknown cause, weight loss, abdominal mass, a positive result of digital rectal examination) 2. Age between 45 to 75 years old, the gender is not limited 3. Willing to participate and sign informed consent Exclusion Criteria: 1. Patients with contraindications for bowel preparation or colonoscopy 2. Patients with known colorectal adenoma or serrated lesions 3. History of colonoscopy within 5 years or polypectomy 4. Patients with inflammatory bowel disease 5. History of CRC and patients clinically highly suspected with colorectal cancer 6. History of hereditary CRC syndrome (including polyposis) 7. Patients taking anticoagulants such as aspirin and warfarin within 7 days, or who have coagulopathy 8. Pregnancy, or severe organ insufficiency (heart, lung, or kidney et al)
References
Publications (5)
- BACKGROUNDNiu F, Wen J, Fu X, Li C, Zhao R, Wu S, Yu H, Liu X, Zhao X, Liu S, Wang X, Wang J, Zou H. Stool DNA Test of Methylated Syndecan-2 for the Early Detection of Colorectal Neoplasia. Cancer Epidemiol Biomarkers Prev. 2017 Sep;26(9):1411-1419. doi: 10.1158/1055-9965.EPI-17-0153. Epub 2017 Jun 15. PMID 28619831
- BACKGROUNDWang J, Liu S, Wang H, Zheng L, Zhou C, Li G, Huang R, Wang H, Li C, Fan X, Fu X, Wang X, Guo H, Guan J, Sun Y, Song X, Li Z, Mu D, Sun J, Liu X, Qi Y, Niu F, Chen C, Wu X, Wang X, Song X, Zou H. Robust performance of a novel stool DNA test of methylated SDC2 for colorectal cancer detection: a multicenter clinical study. Clin Epigenetics. 2020 Oct 30;12(1):162. doi: 10.1186/s13148-020-00954-x. PMID 33126908
- BACKGROUNDGachabayov M, Lebovics E, Rojas A, Felsenreich DM, Latifi R, Bergamaschi R. Performance evaluation of stool DNA methylation tests in colorectal cancer screening: a systematic review and meta-analysis. Colorectal Dis. 2021 May;23(5):1030-1042. doi: 10.1111/codi.15521. Epub 2021 Jan 25. PMID 33410272
- BACKGROUNDYeoh KG, Ho KY, Chiu HM, Zhu F, Ching JY, Wu DC, Matsuda T, Byeon JS, Lee SK, Goh KL, Sollano J, Rerknimitr R, Leong R, Tsoi K, Lin JT, Sung JJ; Asia-Pacific Working Group on Colorectal Cancer. The Asia-Pacific Colorectal Screening score: a validated tool that stratifies risk for colorectal advanced neoplasia in asymptomatic Asian subjects. Gut. 2011 Sep;60(9):1236-41. doi: 10.1136/gut.2010.221168. Epub 2011 Mar 14. PMID 21402615
- BACKGROUNDChiu HM, Ching JY, Wu KC, Rerknimitr R, Li J, Wu DC, Goh KL, Matsuda T, Kim HS, Leong R, Yeoh KG, Chong VH, Sollano JD, Ahmed F, Menon J, Sung JJ; Asia-Pacific Working Group on Colorectal Cancer. A Risk-Scoring System Combined With a Fecal Immunochemical Test Is Effective in Screening High-Risk Subjects for Early Colonoscopy to Detect Advanced Colorectal Neoplasms. Gastroenterology. 2016 Mar;150(3):617-625.e3. doi: 10.1053/j.gastro.2015.11.042. Epub 2015 Nov 25. PMID 26627608