Bladder cancer is one of the most common malignancies of the urinary system and is characterized by high recurrence rates and poor long-term outcomes. Early detection and accurate diagnosis are essential for improving clinical management.
This prospective diagnostic accuracy study aims to develop and validate a precision diagnostic model for bladder cancer based on microfluidic isolation and multiplex detection of urinary exosomes.
A novel microfluidic platform will be developed for rapid and efficient urinary exosome enrichment. Multi-omics approaches, including RNA sequencing and proteomic profiling, will be used to identify bladder cancer-associated urinary exosome biomarkers. A multiplex microfluidic detection chip will subsequently be developed for simultaneous detection of multiple biomarkers.
A diagnostic model integrating urinary exosome biomarker profiles and clinical characteristics will be developed in a training cohort and prospectively validated in an independent cohort. Diagnostic performance will be evaluated using pathological diagnosis as the reference standard.
This study aims to establish a non-invasive, rapid, and accurate diagnostic strategy for bladder cancer.