Development and Validation of a Diagnostic and Screening Method for Gastric Cancer by Combining New Gastric Cancer Screening Score and Serum Biomarkers: A Prospective Study

Objective The New Gastric Cancer Screening Score (NGCSS) has been widely applied in the screening of gastric cancer (GC). The purpose of this study is to establish a novel system for GC screening and early diagnosis by combining NGCSS with serum tumor markers and to validate its robustness. Methods Patients with GC and non-GC diseases, including superficial gastritis (SG), atrophic gastritis (AG), and intestinal metaplasia (IM), were included in the study. They were allocated to a discovery dataset and a validation dataset in a 2:1 ratio. All individuals underwent standardized NGCSS scoring. Additionally, serum samples were obtained for tumor marker detection, including three traditional markers (CA724, CEA, and CA199) and five novel GC-related markers (OPN, TEF3, SOX3, IGFBP1, and Leptin). Results A total of 106 GC and 143 non-GC patients were included in this study, with 167 assigned to the discovery dataset and 82 to the validation dataset. In the discovery dataset, GC and different types of non-GC patients exhibited distinct NGCSS scores and grade levels (P < 0.01). Furthermore, compared to non-GC, GC patients showed significantly increased levels of CEA, OPN, and IGFBP1 in serum (P < 0.001). Multivariate logistic regression indicated that each marker was an independent indicator of GC incidence related to NGCSS (P < 0.001). Additionally, by selecting cutoff values for CEA, OPN, and IGFBP1, a NGCSS-CS[Changshu] screening and prediction system with a total score of 62 points was constructed. Analysis of the validation dataset revealed that NGCSS-CS had better diagnostic performance (AUC = 0.967, P < 0.001) and effectively differentiated between GC and non-GC patients (P < 0.001). Conclusion The new model system based on NGCSS combined with multiple tumor markers is feasible and exhibits improved diagnostic performance. The conclusions of this study require further validation and elaboration through large-sample multicenter follow-up studies.