Mass spectrometry test to detect multiple gene mutations 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
This project will try a nucleic-acid mass spectrometry test on tumor and matched normal tissue to detect many clinically relevant gene mutations in adults with bladder cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lanzhou University Second Hospital Academic / other |
| Locations | 1 site (Lanzhou, Gansu) |
| Trial ID | NCT07424560 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically confirmed urothelial carcinoma of the bladder who can provide sufficient fresh frozen tumor tissue and matched adjacent normal tissue are ideal candidates.
Not a fit: Patients without adequate fresh tumor or paired normal tissue, with inadequate DNA quality or quantity, with recent other malignancies within five years, or who are pregnant or breastfeeding are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the test could provide faster, lower-cost, and highly sensitive detection of clinically important bladder cancer mutations to help guide prognosis and treatment decisions.
How similar studies have performed: Related multiplex and mass-spectrometry–based mutation assays have shown analytical promise in other cancer settings, but large-scale clinical validation specifically in bladder cancer is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lanzhou, Gansu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.