Detection of Bladder Cancer Using Urinary Cell-free DNA and Cellular DNA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- sensitivity of urinalysis by Urine-DNA test
研究概览
简要总结
DNA biomarkers in urine are important diagnostic and prognostic indicators for bladder cancer. Many genetic alterations have been identified in the urinary DNA. However, not all bladder tumors harbor mutations in the most commonly altered oncogenes. Thus, to reach satisfactory sensitivity and specificity a new diagnostic test should include multiple biomarkers. The investigators will conduct a prospective evaluation of a panel of mutations in urine-DNA test for the detection of urothelial bladder carcinoma in patients with gross hematuria for cystoscope.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
sensitivity of urinalysis by Urine-DNA test
时间窗: through study completion, an average of 8 months
number of patients "declared positive" with the Urine-DNA test among the patients actually suffering from bladder carcinoma
specificity of urinalysis by Urine-DNA test
时间窗: through study completion, an average of 8 months
number of patients "declared negative" with the Urine-DNA test among the patients without bladder carcinoma
Identification of positive urine-DNA test results with the next generation sequencing
时间窗: through study completion, an average of 8 months
Identification of presence of positive urine-DNA test results with the designed panel.
Identification of urine-DNA mutations with the next generation sequencing to create an diagnosis algorithm.
时间窗: through study completion, an average of 8 months
Identification of presence or absence of the mutations in urine-DNA with the next generation sequencing to create an idiagnosis algorithm
次要结局
- sensitivity of blood DNA test(through study completion, an average of 8 months)
- specificity of blood DNA test(through study completion, an average of 8 months)
- comparison of the sensitivity of the urine DNA versus blood DNA test(through study completion, an average of 8 months)
- comparison of the specificity of the urine DNA versus blood DNA test(through study completion, an average of 8 months)