Clinical trial · Observational
Multiplex Mutation Detection Using Mass Spectrometry in Bladder Cancer
Comprehensive Analysis of the Key Mutation Spectrum in Bladder Cancer: Establishment and Clinical Validation of a Multiplex Mutation Detection System Based on Nucleic Acid Mass Spectrometry
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Therapy for Bladder Cancer | — | UNRESOLVED | — |
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Bladder Cancer Recurrence | — | UNRESOLVED | — |
| Progression of Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiplex Mutation Detection System for Bladder Cancer (Nucleic Acid Mass Spectrometry) | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- NMIBC (Non-Muscle Invasive Bladder Cancer) Study Group
- description
- 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.
- interventionNames
- Genetic: Multiplex Mutation Detection System for Bladder Cancer (Nucleic Acid Mass Spectrometry)
- label
- MIBC (Muscle Invasive Bladder Cancer) Study Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed diagnosis of urothelial carcinoma of the bladder (any stage, including non-muscle invasive and muscle invasive). \- 2. Availability of sufficient tumor tissue specimen (fresh frozen) for DNA extraction and mutation analysis. \- 3. Age ≥ 18 years at time of diagnosis. Exclusion Criteria: 1. History of other malignant tumors within the past 5 years, except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. \- 2. Inadequate quality or quantity of tumor tissue DNA for mutation panel analysis (e.g., severe DNA degradation, insufficient DNA yield). \- 3. Pregnancy or breastfeeding. \- 4. Serious uncontrolled intercurrent illness that would interfere with study follow-up or compliance, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
References
Publications (0)
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