Assessing diagnostic accuracy of circulating microRNAs as biomarkers for ovarian cancer: a systematic review and meta-analysis

Abstract Ovarian cancer is one of the deadliest gynecological malignancies, mainly because of its silent development and the lack of effective conventional methods for diagnosis. Because of their extraordinary stability in bio fluids and expression signatures that specifically correlate with tumors, circulating microRNAs (miRNAs) have received much attention as non-invasive diagnostic biomarkers. This meta-analysis evaluates the diagnostic value of circulating miRNAs for early ovarian cancer. A systematic literature review was performed in line with PRISMA-DTA guidelines in PubMed, EMBASE, and Web of Science until March 8, 2025. A total of 24 studies were eligible. Pooled diagnostic metrics (sensitivity and specificity, likelihood ratios, and diagnostic odds ratio (DOR)) were calculated based upon the bivariate random effect model. Summary receiver operating characteristic (sROC) curves were generated and subgroup and meta-regression analyses performed to investigate heterogeneity. Sensitivity analyses were performed to assess the strength of the pooled estimates. The combined sensitivity, specificity and DOR was 0.749 (95% CI: 0.702–0.791), 0.748 (95% CI:0.695–0.794) and 8.403 (95% CI: 6.308–11.194) respectively, which means a moderate-to-high diagnostic efficacy. Screening efficacy of serum-based and PBMC-based tests differed significantly at the DOR of 10.55 being maximum amongst serum assays. Biospecimen and regional differences contributed substantially to heterogeneity. The results were robust according to sensitivity analyses, and there was no obvious publication bias based on Deeks’ test (p = 0.08). Circulating miRNAs, especially serum-based profiles, are highly promising as non-invasive diagnosis in ovarian cancer. Standardization of protocols and prospective validation is necessary for clinical application.