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Multiplex Mutation Detection Using Mass Spectrometry in Bladder Cancer

Recruitingn/aAges 18 Years - anyAllZhilong Dong
NCT07424560 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 identifi

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📋 Eligibility rules (as published)
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.
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What it tests

  • Multiplex Mutation Detection System for Bladder Cancer (Nucleic Acid Mass Spectrometry)
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Where

1 site
The Second Hospital of Lanzhou University
Lanzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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