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Microfluidic Urinary Exosome-Based Diagnostic Model for Bladder Cancer
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Summary
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.
Official title: Development and Prospective Validation of a Precision Diagnostic Model for Bladder Cancer Based on Microfluidic Isolation and Multiplex Detection of Urinary Exosomes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2025-10-01
Completion Date
2027-09
Last Updated
2026-07-30
Healthy Volunteers
Not specified
Conditions
Interventions
Liquid biopsy
Liquid biopsy
Locations (1)
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China