Microfluidic Urinary Exosome-Based Diagnostic Model for Bladder Cancer

NCT07735858 | Active Not Recruiting DMC

• 2 other identifiers: NCC550825/4165362
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of urinary exosome-based model for bladder cancer detection

  The primary outcome is the diagnostic performance of the urinary exosome-based model compared with pathological diagnosis as the reference standard.

  At completion of prospective validation (September 2027)

Study Arms (3)

Bladder Cancer Cohort

Participants with pathologically confirmed bladder cancer, including non-muscle-invasive bladder cancer (Ta and T1) and muscle-invasive bladder cancer (≥T2).

Diagnostic Test: Liquid biopsy

Benign Urological Disease Control Cohort

Participants diagnosed with benign urological diseases without evidence of malignancy.

Diagnostic Test: Liquid biopsy

Other Urological Malignancy Cohort

Participants with other urinary system malignancies included for evaluation of diagnostic specificity during the validation phase.

Diagnostic Test: Liquid biopsy

Interventions

Liquid biopsy DIAGNOSTIC_TEST

Liquid biopsy

Benign Urological Disease Control Cohort; Bladder Cancer Cohort; Other Urological Malignancy Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bladder cancer or other urinary diseases and healthy individuals

You may qualify if:

• \. Age ≥18 years.
• \. Patients with bladder cancer confirmed by pathological examination.
• \. Patients with benign urological diseases confirmed by clinical evaluation.
• \. Ability to provide urine samples and relevant clinical information.
• \. Written informed consent provided.

You may not qualify if:

• \. History of other malignant tumors, except participants specifically included in the validation cohort.
• \. Severe organ dysfunction.
• \. Glomerulonephritis.
• \. Recent significant urinary tract injury.
• \. Inadequate urine sample availability.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Tsinghua University: collaborator
• Beijing Proteome Research Center: collaborator

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: July 30, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

CN (1)