Multiplex Mutation Detection Using Mass Spectrometry in Bladder Cancer

Sponsor
Zhilong Dong
Study ID
NCT07424560
Status
Recruiting
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Conditions

  • Adjuvant Therapy for Bladder Cancer
  • Bladder Cancer
  • Bladder Cancer Recurrence
  • Progression of Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Multiplex Mutation Detection System for Bladder Cancer (Nucleic Acid Mass Spectrometry) — GENETIC
    This study uses a multiplex mutation detection system for bladder cancer based on nucleic acid mass spectrometry. The system is designed to identify genetic alterations in bladder cancer-related genes, including Fibroblast Growth Factor Receptor 3 (FGFR3), Tumor Protein P53 (TP53), and other relevant genes. The platform offers high-throughput, multiplex mutation detection with high analytical sensitivity and cost efficiency, suitable for potential clinical use. Tumor tissue samples will be prospectively collected from patients with bladder cancer who elect to undergo surgery. The study is observational, with no active intervention, therapeutic modification, or influence on clinical treatment decisions. Mutation status from tissue analysis will be evaluated for correlations with clinical outcomes, including recurrence, progression, and treatment response.

Study Details

Bladder cancer is a highly heterogeneous malignancy characterized by frequent genetic alterations that are closely associated with disease progression, recurrence risk, and treatment response. However, existing mutation detection approaches are often limited by high cost, complex workflows, or insufficient capacity for multiplex and low-frequency mutation analysis, which restricts their routine clinical application. The purpose of this study is to establish and clinically validate a multiplex mutation detection system for bladder cancer based on nucleic acid mass spectrometry. Using fresh tumor tissue and matched adjacent normal tissue samples collected from patients with bladder cancer, a targeted mutation panel comprising key functional mutations with demonstrated clinical relevance will be constructed. The matched normal tissues serve as germline references to enable accurate identification of somatic mutations. The analytical performance of the system, including sensitivity, specificity, and concordance with whole-genome sequencing, will be systematically evaluated. In addition, the clinical utility of the mutation panel in risk stratification and treatment decision support will be explored by comparing its predictive value with established clinical models and guideline-recommended tools. The ultimate goal is to develop a cost-effective, reproducible, and clinically applicable molecular testing strategy that can support precision diagnosis and individualized management of patients with bladder cancer.

Key Dates

First listed
Feb 20, 2026
Start date
Feb 25, 2026
Status verified
Feb 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: NMIBC (Non-Muscle Invasive Bladder Cancer) Study Group
    This cohort includes patients diagnosed with non-muscle invasive bladder cancer. Participants are categorized according to post-operative recurrence and progression status, as well as response to intravesical therapy (recurrence versus no recurrence; response versus non-response). Survival differences between mutation-positive and mutation-negative groups will be assessed using Kaplan-Meier survival analysis. Predictive models for post-surgical recurrence, progression, and treatment response will be developed using multivariable Cox proportional hazards regression analysis. Model performance will be validated in 30% of participants and compared with established risk models from the European Association of Urology and the European Organisation for Research and Treatment of Cancer.
  • Arm: MIBC (Muscle Invasive Bladder Cancer) Study Group
    This cohort includes patients diagnosed with muscle invasive bladder cancer. Participants are categorized according to recurrence after adjuvant therapy and the presence or absence of distant metastasis. Survival differences between mutation-positive and mutation-negative groups will be assessed using Kaplan-Meier survival analysis. A predictive model for recurrence and distant metastasis following adjuvant therapy will be developed using multivariable Cox proportional hazards regression analysis. Model performance will be validated in the remaining 30% of participants. Predictive accuracy will be compared with existing clinical assessment methods, including clinicopathological characteristics, single-gene mutation markers, and immunohistochemical biomarkers.

Primary Outcome Measure

Survival Differences Between Mutated and Non-mutated Groups in Bladder Cancer Patients [ Time Frame: Survival will be assessed at post-surgical follow-up at 6 months, 1 year, 2 years, and 3 years, including recurrence, progression, and metastasis-free survival events over a 3-year period. ]

Central Contacts

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