Mass spectrometry test to detect multiple gene mutations in bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project develops and clinically validates a multiplex mutation detection system based on nucleic acid mass spectrometry using fresh tumor tissue and paired adjacent normal tissue. In the first phase, investigators will build a targeted panel of up to 30 key mutation sites selected from databases such as TCGA, OncoKB, and ClinVar, focusing on genes like FGFR3 and TP53. In the second phase, the panel's analytical and clinical performance will be tested on 400 paired samples to measure sensitivity, specificity, limit of detection (reported down to 0.1% variant allele frequency), and quantitative allele frequencies. Matched normal tissues are used as germline references to accurately identify somatic mutations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically confirmed diagnosis of urothelial carcinoma of the bladder (any stage, including non-muscle invasive and muscle invasive).

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2. Availability of sufficient tumor tissue specimen (fresh frozen) for DNA extraction and mutation analysis.

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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.

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2. Inadequate quality or quantity of tumor tissue DNA for mutation panel analysis (e.g., severe DNA degradation, insufficient DNA yield).

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3. Pregnancy or breastfeeding.

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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.

Where it's running

• The Second Hospital of Lanzhou University
  Lanzhou, Gansu, China Recruiting

Study contacts

• Principal investigator: Zhilong Dong, Doctor of Medicine — Lanzhou University Second Hospital
• Study coordinator: Weiguang Yang, Doctor of Medicine
• Email: yangwg2024@lzu.edu.cn
• Phone: +86 18221095087

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.