MedTrace Logo

Microfluidic Urinary Exosome-Based Diagnostic Model for Bladder Cancer

NCT07735858 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-07-30

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Liquid biopsy

Liquid biopsy

Sponsors & Collaborators

  • Tsinghua University

    collaborator OTHER

  • Beijing Proteome Research Center

    collaborator OTHER

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07735858 on ClinicalTrials.gov