NCT07735858Active, not recruiting
Microfluidic Urinary Exosome-Based Diagnostic Model for Bladder Cancer
Development and Prospective Validation of a Precision Diagnostic Model for Bladder Cancer Based on Microfluidic Isolation and Multiplex Detection of Urinary Exosomes
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 25 Jul 2026
- Start date
- 1 Oct 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Bladder cancer
- NCT number
- NCT07735858
What you commit to
- Study type: Observational
- Planned participants: 300
- From 1 Oct 2025 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.