Novel and Effective Blood-Based miRNA Diagnostic Panel for Gastric Cancer: A Pilot Study in a Japanese Population.

[BACKGROUND] Gastric cancer (GC) has a high prevalence in Asian countries, and there is an unmet need for non-invasive and efficient GC screening methods. This study evaluated the diagnostic efficacy of GASTROClear, a panel of blood serum miRNAs for the detection of GC, in a Japanese population.

[METHODS] We conducted a pilot cohort study, comprising 103 patients with GC and 122 healthy controls. Serum samples were prospectively collected from study participants at two Japanese hospitals using a predefined blood-processing protocol. The diagnostic performance of GASTROClear was analyzed using a receiver operating characteristic curve and cutoff. By applying a logistic regression algorithm, we evaluated the diagnostic efficacy of novel combinations of GC diagnostic biomarker panels, consisting of GASTROClear and alternative serum markers (anti-Helicobacter pylori [Hp] antibody and pepsinogen).

[RESULTS] Most patients had Stage I (58%) GC and were asymptomatic (59%). The area under the curve (AUC) value for the detection of GC using GASTROClear was 0.80, with 70.9% sensitivity and 75.2% specificity. GASTROClear performed equally well within the subgroups based on age, sex, symptoms, Hp status, and tumor characteristics. We improved the diagnostic performance of GASTROClear by combining it with an anti-Hp antibody and pepsinogen. This yielded an AUC value of 0.88, with the highest specificity (86.9%) at a fixed sensitivity (70.9%).

[CONCLUSIONS] GASTROClear demonstrated competent diagnostic efficacy for GC in the detection of GC in our Japanese cohort, even in the early stages of cancer and asymptomatic cases. Its combination with existing serum markers may contribute to efficient risk stratification to detect GC.