Diagnostic accuracy of miRNA in detection of upper aerodigestive tract malignancies: a protocol for systematic review.

Abstract

Upper aerodigestive tract (UADT) malignancies, involving oral cavity, pharynx, larynx and related anatomical regions, are associated with substantial morbidity and mortality worldwide. Early diagnosis remains challenging because conventional diagnostic approaches are often invasive, costly and frequently detect disease at advanced stages. MicroRNAs (miRNAs) involved in post-transcriptional gene regulation have recently emerged as promising minimally invasive biomarkers due to their remarkable stability in biological fluids and their dysregulated expression in cancer. Although literature showcases the diagnostic value of miRNA signatures for UADT malignancies, the reported diagnostic performance remains inconsistent. Therefore, a comprehensive synthesis of current evidence is essential to determine the overall diagnostic precision and clinical applicability of miRNA-based assays. We will report the results of the systematic review as per Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies (PRISMA-DTA) reporting guidelines and adhere to the recommendations of the Cochrane Collaboration Handbook for Diagnostic Test Accuracy Reviews for conducting this review. The electronic databases of PubMed, Scopus, Web of Science and Embase will be systematically searched from inception onwards. Studies assessing the diagnostic performance of miRNA biomarkers in histopathologically confirmed UADT malignancies will be included. Two authors will independently perform study selection, data extraction and quality assessment (Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2)). Diagnostic accuracy meta-analysis will be conducted using a hierarchical bivariate random-effects model (Reitsma model) to jointly pool sensitivity and specificity estimates while accounting for heterogeneity and threshold effects. Hierarchical summary receiver operating characteristic curves will be constructed, and we will analyse pooled estimates of sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and diagnostic OR at 95% CIs. Meta-regression followed by subgroup analysis will be undertaken to explore potential sources of heterogeneity, including specimen type, miRNA profiling method, study design and patient characteristics. This study will synthesise data from previously published literature without involving individual patient data or direct participant involvement. Findings from this review will be dispersed via publication in a peer-reviewed journal and through presentations at National/International scientific platforms. CRD420261384413.