Microfluidic Urinary Exosome-Based Diagnostic Model for Bladder Cancer

This study aims to establish and validate a urinary exosome-based diagnostic model for bladder cancer using microfluidic technologies.

The study consists of four stages:

First, a novel microfluidic urinary exosome isolation platform will be developed using magnetic stirring-assisted resuspension and tangential flow washing technologies to improve exosome recovery efficiency.

Second, bladder cancer-associated urinary exosome biomarkers will be identified using transcriptomic and proteomic approaches. Candidate nucleic acid and protein biomarkers will be screened and validated.

Third, a multiplex microfluidic detection chip will be developed to enable simultaneous detection of multiple urinary exosome-derived biomarkers.

Fourth, a diagnostic model integrating biomarker expression profiles and clinical characteristics will be constructed in a training cohort and prospectively validated in an independent cohort.

Pathological diagnosis will serve as the reference standard for evaluating diagnostic performance.

Inclusion criteria

• 1. Age ≥18 years.

• Patients with bladder cancer confirmed by pathological examination.

• Patients with benign urological diseases confirmed by clinical evaluation.

• Ability to provide urine samples and relevant clinical information.

• Written informed consent provided.

Exclusion criteria

• 1. History of other malignant tumors, except participants specifically included in the validation cohort.

• Severe organ dysfunction.

• Glomerulonephritis.

• Recent significant urinary tract injury.

• Inadequate urine sample availability.