Development and Prospective Validation of a Precision Diagnostic Model for Bladder Cancer Based on Microfluidic Isolation and Multiplex Detection of Urinary Exosomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of urinary exosome-based model for bladder cancer detection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Diagnostic accuracy of urinary exosome-based model for bladder cancer detection
时间窗: 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.
次要结局
未报告次要终点
研究者
Xiongjun Ye
Phd
Cancer Institute and Hospital, Chinese Academy of Medical Sciences