Bladder Cancer
Conditions
Brief 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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTLiquid biopsy
Liquid biopsy
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Tsinghua University
Beijing Proteome Research Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 1\. Age ≥18 years. 2\. Patients with bladder cancer confirmed by pathological examination. 3\. Patients with benign urological diseases confirmed by clinical evaluation. 4\. Ability to provide urine samples and relevant clinical information. 5\. Written informed consent provided.
Exclusion criteria
* 1\. History of other malignant tumors, except participants specifically included in the validation cohort. 2\. Severe organ dysfunction. 3\. Glomerulonephritis. 4\. Recent significant urinary tract injury. 5\. Inadequate urine sample availability.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of urinary exosome-based model for bladder cancer detection | At completion of prospective validation (September 2027) | The primary outcome is the diagnostic performance of the urinary exosome-based model compared with pathological diagnosis as the reference standard. |
Countries
China
Outcome results
None listed