A Clinical, Non-intervention Study of the Cxbladder Urine Test for the Detection of Recurrent Urothelial Carcinoma (UC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 803
- 试验地点
- 9
- 主要终点
- Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively.
研究概览
简要总结
The aim of this trial is to determine the performance characteristics of the Cxbladder test for the detection of recurrent urothelial carcinoma (UC) in patients with a recent history of urinary tract UC, who have been treated according to standard practice and are undergoing routine investigative cystoscopy.
The gold standard for determination of clinical truth is cystoscopy, plus any follow up investigations relating to the current visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Confirmed positive diagnosis for primary or recurrent urinary tract UC over the past 2 years.
- •Patient is undergoing investigative cystoscopies for the monitoring of recurrence of UC at intervals prescribed by a clinical practitioner
- •Patient is 18 years of age or older.
排除标准
- •Prior genitourinary manipulation (cystoscopy / catheterisation / dilation) in the 14 days before urine collection, current urinary tract infection, current or known history of urinary tract inflammatory disorder, recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders, recent history of pyelonephritis
- •Patient has undergone total bladder cystectomy as treatment for bladder UC
结局指标
主要结局
Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively.
时间窗: The outcome measure will be assessed by 6 months after trial completion.
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
时间窗: The outcome measure will be assessed by 6 months after trial completion.
The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients with recurrent disease.
次要结局
- Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.(The outcome measure will be assessed by 6 months after trial completion.)
- Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 BladderChek Assay.(The outcome measure will be assessed by 6 months after trial completion.)
- Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 ELISA Assay.(The outcome measure will be assessed by 6 months after trial completion.)