Clinical trial · Observational
CRC Screening Using mSEPT9 (Methylated Septin 9) in Chinese Population
Screening of Colorectal Cancer Using Improved SEPT9 (Septin 9) Gene Methylation Assay in Chinese Population
- 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 purpose of this study is to evaluate the performance of the SEPT9 gene methylation assay in Colorectal cancer (CRC) high-risk population in Chinese hospitals using the opportunistic screening method. The trial plans to evaluate a Chinese domestic SEPT9 assay kit produced by BioChain (Beijing) Science and Technology Corporation, who is a close partner of Epigenomics AG, the producer for Epi proColon 2.0 CE.
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 |
|---|---|---|---|
| Adenomatous Polyp of Colon | Colon Adenomatous Polyp | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Other Cancers | — | UNRESOLVED | — |
| Other Disease/Injury | — | UNRESOLVED | — |
| Polyps | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- CRC group
- description
- stage 0-IV CRC subjects
- label
- precancerous disease group
- description
- subjects with adenoma or polyps
- label
- other disease group
- description
- subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
Primary outcomes (1)
- measure
- Ct Value (Ct Values From PCR Reaction)
- timeFrame
- 1 year
- description
- the number of PCR cycles where the amplification signal starts to be observed
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
- Maximum age
- 88 Years
Show eligibility criteria text
Inclusion Criteria: 1. sample information is complete, including sample number, gender, age and clinical diagnosis; 2. CRC group: positive samples refer to samples confirmed to be CRC with colonoscopy and/or pathological examination; 3. precancerous disease group: all samples confirmed to be adenoma and polyps by colonoscopy and/or pathological examination 4. other disease group: samples confirmed to be other GI diseases, other cancers or no evidence of diseases by colonoscopy and/or pathological examination Exclusion Criteria: 1. the patient information is not complete; 2. the sample information is not complete; 3. history of colorectal cancer surgery or other cancer history, or any chemotherapy; 4. women in pregnancy; 5. samples not comply with any of the above selection criteria
References
Publications (0)
Data not yet available