Diagnostic Accuracy of Post-Treatment Circulating Tumor DNA for Minimal Residual Disease Detection in Early-Stage Breast Cancer: A Systematic Review and Meta-Analysis of Diagnostic Test Accuracy

This project contains the prespecified protocol for a systematic review and diagnostic test accuracy meta-analysis evaluating the performance of post-treatment circulating tumor DNA (ctDNA) for minimal residual disease (MRD) detection in early-stage breast cancer (stage I–III). The review follows PRISMA-DTA guidelines and applies a bivariate random-effects model to jointly estimate pooled sensitivity and specificity. Risk of bias is assessed using QUADAS-2. The objective is to quantify diagnostic performance parameters including sensitivity, specificity, likelihood ratios, diagnostic odds ratio, and area under the summary ROC curve (AUC), and to evaluate clinical utility through pre-test to post-test probability transitions. This registration was completed prior to final data synthesis and manuscript submission.