{"title":"Septin9 gene methylation in plasma for gastric cancer detection: a systematic review and meta-analysis.","authors":"Yiming Wang, Yuan Wang, Jiaqi Kang, Shan He, Ping Zhang","doi":"10.1080/17520363.2026.2685066","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the plasma-based methylated Septin9 (mSEPT9) diagnostic accuracy for gastric cancer (GC) and analyze its performance across different subgroups.</p><p><strong>Methods: </strong>Through comprehensive computer searching, we systematically collected clinical trials on the diagnostic efficacy of plasma mSEPT9 in GC. The search scope covered PubMed, Web of Science, the Cochrane Library, Embase, CNKI, WanFang Data and VIP databases from their establishments to 31 August 2025. Study quality was rigorously assessed with the assistance of Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2). Meta-analysis via Stata 17.0 and Meta-Disc 1.4 was performed.</p><p><strong>Results: </strong>This study included 9 articles containing 10 studies, encompassing 3,120 participants. Meta-analysis revealed a pooled sensitivity of 0.40 (95%CI: 0.34-0.47), specificity of 0.94 (95%CI: 0.91-0.96), diagnostic odds ratio of 11.10 (95%CI: 6.42-19.18), area under the curve of 0.78 (95%CI: 0.74-0.82). Meta-regression identified sample size and positive criteria algorithm as potential contributors to heterogeneity in sensitivity, although the associations were only of borderline statistical significance. Other covariables were not significantly associated with heterogeneity.</p><p><strong>Conclusion: </strong>Plasma mSEPT9 demonstrated high specificity and relatively low sensitivity in GC. The assay may be unsuitable for general population screening but showed promise as an adjunctive marker in high-risk patients. Heterogeneity and geographical concentration may influence the assessment of mSEPT9.</p><p><strong>Protocol registration: </strong>www.crd.york.ac.uk/prospero identifier is CRD420251140125.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"531-542"},"PeriodicalIF":2.1000,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13432830/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biomarkers in medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/17520363.2026.2685066","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/6/12 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Objective: To evaluate the plasma-based methylated Septin9 (mSEPT9) diagnostic accuracy for gastric cancer (GC) and analyze its performance across different subgroups.
Methods: Through comprehensive computer searching, we systematically collected clinical trials on the diagnostic efficacy of plasma mSEPT9 in GC. The search scope covered PubMed, Web of Science, the Cochrane Library, Embase, CNKI, WanFang Data and VIP databases from their establishments to 31 August 2025. Study quality was rigorously assessed with the assistance of Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2). Meta-analysis via Stata 17.0 and Meta-Disc 1.4 was performed.
Results: This study included 9 articles containing 10 studies, encompassing 3,120 participants. Meta-analysis revealed a pooled sensitivity of 0.40 (95%CI: 0.34-0.47), specificity of 0.94 (95%CI: 0.91-0.96), diagnostic odds ratio of 11.10 (95%CI: 6.42-19.18), area under the curve of 0.78 (95%CI: 0.74-0.82). Meta-regression identified sample size and positive criteria algorithm as potential contributors to heterogeneity in sensitivity, although the associations were only of borderline statistical significance. Other covariables were not significantly associated with heterogeneity.
Conclusion: Plasma mSEPT9 demonstrated high specificity and relatively low sensitivity in GC. The assay may be unsuitable for general population screening but showed promise as an adjunctive marker in high-risk patients. Heterogeneity and geographical concentration may influence the assessment of mSEPT9.
Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD420251140125.
期刊介绍:
Biomarkers are physical, functional or biochemical indicators of physiological or disease processes. These key indicators can provide vital information in determining disease prognosis, in predicting of response to therapies, adverse events and drug interactions, and in establishing baseline risk. The explosion of interest in biomarker research is driving the development of new predictive, diagnostic and prognostic products in modern medical practice, and biomarkers are also playing an increasingly important role in the discovery and development of new drugs. For the full utility of biomarkers to be realized, we require greater understanding of disease mechanisms, and the interplay between disease mechanisms, therapeutic interventions and the proposed biomarkers. However, in attempting to evaluate the pros and cons of biomarkers systematically, we are moving into new, challenging territory.
Biomarkers in Medicine (ISSN 1752-0363) is a peer-reviewed, rapid publication journal delivering commentary and analysis on the advances in our understanding of biomarkers and their potential and actual applications in medicine. The journal facilitates translation of our research knowledge into the clinic to increase the effectiveness of medical practice.
As the scientific rationale and regulatory acceptance for biomarkers in medicine and in drug development become more fully established, Biomarkers in Medicine provides the platform for all players in this increasingly vital area to communicate and debate all issues relating to the potential utility and applications.
Each issue includes a diversity of content to provide rounded coverage for the research professional. Articles include Guest Editorials, Interviews, Reviews, Research Articles, Perspectives, Priority Paper Evaluations, Special Reports, Case Reports, Conference Reports and Company Profiles. Review coverage is divided into themed sections according to area of therapeutic utility with some issues including themed sections on an area of topical interest.
Biomarkers in Medicine provides a platform for commentary and debate for all professionals with an interest in the identification of biomarkers, elucidation of their role and formalization and approval of their application in modern medicine. The audience for Biomarkers in Medicine includes academic and industrial researchers, clinicians, pathologists, clinical chemists and regulatory professionals.