Xpert Bladder Cancer Monitor; Prospective, Single, Tertiary-care Center Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Accuracy of Xpert Bladder Cancer Monitor in monitoring of non muscle invasive bladder cancer by comparing its results to the results of the standard tool of monitoring of bladder cancer (diagnostic cystoscopy)
研究概览
简要总结
The primary objective of this prospective, single-centre study is to establish the clinical performance characteristics of Xpert Bladder Cancer Monitor on the GeneXpert Instrument Systems in comparison to the methods currently used at the site for detecting recurrent bladder cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient shall meet all of the following criteria in order to be considered eligible for enrollment:
- •Patient has been diagnosed with NMIBC within 24 months of enrollment
- •At the time of the enrollment visit, the patient is scheduled for a cystoscopy within the next 6 weeks of enrollment
排除标准
- •Patient has had an excision procedure or BCG treatment within six weeks (42 days) before enrollment.
结局指标
主要结局
Accuracy of Xpert Bladder Cancer Monitor in monitoring of non muscle invasive bladder cancer by comparing its results to the results of the standard tool of monitoring of bladder cancer (diagnostic cystoscopy)
时间窗: within 1 month after test assessment
Xpert Bladder Cancer Monitor performance shall be established in recurrence patients relative to cystoscopy (for disease negative patients) or histology (for disease positive patients)and relative to a currently used diagnostic assay (urine cytology)which is the standard of care used for detecting recurrent bladder cancer at the site. In this study, clinical sensitivity shall be established in patients who have been previously diagnosed with bladder cancer and are scheduled for a standard of care (SOC) surveillance cystoscopy
次要结局
未报告次要终点
研究者
Amr Abdel-Lateif El-Sawy
Principal Investigator
Mansoura University