--- title: "miRNA Diagnostic Accuracy for Upper Aerodigestive Tract Malignancies: Systematic Review Protocol" id: "bmj-open-7-diagnostic-accuracy-of-mirna-in-detection-of-upper-aerodigestive-tract" canonical_url: "https://medichelpline.com/clinical-feed/bmj-open-7-diagnostic-accuracy-of-mirna-in-detection-of-upper-aerodigestive-tract" content_type: "clinical_feed_article" specialty: "Oncology" source_name: "BMJ Open" source_url: "http://bmjopen.bmj.com/cgi/content/short/16/9/e122674?rss=1" published_at: "2026-09-04T11:29:48.000Z" evidence_level: "Journal Feed" license: "CC-BY-NC-4.0 / Informational Use" --- # miRNA Diagnostic Accuracy for Upper Aerodigestive Tract Malignancies: Systematic Review Protocol ## Provenance & Clinical Metadata - **Canonical URL:** https://medichelpline.com/clinical-feed/bmj-open-7-diagnostic-accuracy-of-mirna-in-detection-of-upper-aerodigestive-tract - **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md) - **Primary Source:** BMJ Open - **Source URL:** [Original Journal Publication](http://bmjopen.bmj.com/cgi/content/short/16/9/e122674?rss=1) - **Published At:** 2026-09-04T11:29:48.000Z - **Evidence Rating:** Journal Feed ## Executive GIST (TL;DR) - This protocol outlines a planned systematic review and meta-analysis assessing the diagnostic accuracy of **miRNA** biomarkers for upper aerodigestive tract (**UADT malignancies**) involving the oral cavity, pharynx, larynx and adjacent regions. - Rationale: UADT cancers cause high morbidity and mortality; current diagnostics can be invasive, costly, and often detect advanced disease. miRNAs are stable in biological fluids and show dysregulated expression in cancer, making them promising minimally invasive biomarkers. - Literature reports variable and inconsistent diagnostic performance for miRNA signatures, creating the need for a comprehensive evidence synthesis to evaluate overall precision and clinical applicability. - Methodological framework: review will follow **PRISMA-DTA** reporting guidelines and the Cochrane Handbook for Diagnostic Test Accuracy Reviews. - Data sources: systematic searches of PubMed, Scopus, Web of Science, and Embase from inception onward. - Study inclusion: studies that assess diagnostic performance of miRNA biomarkers in histopathologically confirmed UADT malignancies. - Process: dual independent screening, data extraction and quality assessment using **QUADAS-2**. - Statistical plan: hierarchical bivariate random-effects (Reitsma) model to jointly pool **sensitivity** and **specificity**, construct hierarchical summary receiver operating characteristic curves, and report pooled sensitivity, specificity, positive and negative likelihood ratios, and diagnostic odds ratios with 95% CIs. - Heterogeneity: meta-regression and subgroup analyses will explore sources including specimen type, miRNA profiling method, study design and patient characteristics. - Ethics and dissemination: no primary participant data; results to be published and presented at scientific forums. PROSPERO registration CRD420261384413. ## Clinical Analysis & Structured Key Points Introduction 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. Methods and analysis 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. Ethics and dissemination 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. 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