Urine-DNA Biomarkers in Detecting Bladder Cancer

Urinary DNA representative of the tumour genome provide a promising resource as a liquid biopsy for non-invasive genomic profiling of urothelial bladder cancers. Voided urine samples will be collected prior to cystoscopy. Cell free DNA and cellular DNA will both be extracted and analyzed. A blood sample will be taken. In patients with bladder wall findings suspicious of cancer, a bladder wall biopsy will be taken and submitted for histopathology examination, according to clinical standard practice. Next generation sequencing will be applied and hotspots mutations in DNA from urine, blood and tumor. Logistic regression was used to analyze the association between predictor variables and bladder cancer. The investigators will confirm a couple of common mutations occured in urine-DNA and blood-derived DNA simultaneously and verify the specificity and sensitivity of individual variance or mutation combinations to establish an predictive model with optimal robustness in diagnosis of bladder cancer. Moreover, external consistency test will be performed on subsequent patients collection.

Inclusion criteria

• patients with gross hematuria or other clinical sympton suspected of bladder cancer.
• male or female patients aged >= 18 years.
• available tumor tissue, urine and blood sample.
• signed informed consent form.

Exclusion criteria

• prior diagnosis of cancer except bladder cancer
• age under 18 years
• individuals unwilling to sign the IRB-approved consent form
• comorbidities that would prohibit or make serial urine collection and cystoscopy examine difficult or impossible.