N/A
N=1,200
CRC Screening Using mSEPT9 (Methylated Septin 9) in Chinese Population
Colorectal Cancer · Adenomatous Polyp of Colon · Polyps · Other Disease/Injury · Other Cancers
Bottom Line
View on ClinicalTrials.gov: NCT02540850 ↗Enrolled (actual)
1,200
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Ct Value (Ct Values From PCR Reaction) — 38.4; 44.3; 44.6 Ct
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- BioChain (Beijing) Science and Technology, Inc.
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ct Value (Ct Values From PCR Reaction) |
38.4; 44.3; 44.6 | — |
| SECONDARY Sensitivity (Sensitivity of mSEPT9 Assay in Detecting Colorectal Cancer) |
76.6; 8.2; 0 | — |
| SECONDARY Specificity (Specificity of mSEPT9 Assay in Non-CRC Diseases and NED (no Evidence of Diseases)) |
0; 0; 95.9 | — |
| SECONDARY PPV (the Positive Predictive Value of mSEPT9 Assay in the Population) |
83.8; 0; 0 | — |
| SECONDARY NPV (the Negative Predictive Value of mSEPT9 Assay in the Population) |
0; 0; 91.1 | — |
| SECONDARY Positivity Rate (The Ratio of Positive mSEPT9 Results in the Population) |
76.6; 8.2; 3.9 | — |
| SECONDARY Consistency (the Overall Ratio of True Positive and True Negative) |
89.2; 89.2; 89.2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- sample information is complete, including sample number, gender, age and clinical diagnosis;
- CRC group: positive samples refer to samples confirmed to be CRC with colonoscopy and/or pathological examination;
- precancerous disease group: all samples confirmed to be adenoma and polyps by colonoscopy and/or pathological examination
- 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
- the patient information is not complete;
- the sample information is not complete;
- history of colorectal cancer surgery or other cancer history, or any chemotherapy;
- women in pregnancy;
- samples not comply with any of the above selection criteria
Data sourced from ClinicalTrials.gov (NCT02540850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.