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NCT07735858

Microfluidic Urinary Exosome-Based Diagnostic Model for Bladder Cancer

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

Liquid biopsy

Liquid biopsy

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China