A Randomized Cross-Over Study to Evaluate Patient Preference and Satisfaction With Urine-based Molecular Testing Versus Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Preference for CxBladder Monitor compared to cystoscopy
研究概览
简要总结
The purpose of this study is to evaluate patient-reported preference for urine based molecular testing (CxBladder Monitor) compared to cystoscopy for patients on surveillance for Nonmuscle Invasive Bladder Cancer (NMIBC). Urine based molecular testing involves noninvasive testing of a urine sample for biomarkers associated with disease recurrence. Cystoscopy is an examination of the bladder and urethra using a thin tube like instrument that is inserted into the urethra.
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
- •Male or female with a history of histologically confirmed nonmuscle invasive bladder cancer (NMIBC) who have at least 6 months of disease-free survival from last recurrence.
- •Able to provide urine for testing and comply with study protocol.
- •Have an email address and be willing to complete surveys online.
排除标准
- •History of non-urothelial bladder cancer (primary squamous, adenocarcinoma, and small cell carcinoma)
- •Patients with predominant (>50%) variant histology
- •Patients with a history of upper tract and/or urethral cancer
- •Women who are pregnant
研究组 & 干预措施
Arm A: CxBladder followed by cystoscopy
Arm A will undergo testing with CxBladder 3 months after randomization followed by a cystoscopy 3 months thereafter
干预措施: CxBladder Monitor (Diagnostic Test)
Arm A: CxBladder followed by cystoscopy
Arm A will undergo testing with CxBladder 3 months after randomization followed by a cystoscopy 3 months thereafter
干预措施: Cystoscopy (Diagnostic Test)
Arm B: cystoscopy followed by CxBladder
Arm B will undergo cystoscopy 3 months after randomization followed by testing with CxBladder 3 months thereafter.
干预措施: CxBladder Monitor (Diagnostic Test)
Arm B: cystoscopy followed by CxBladder
Arm B will undergo cystoscopy 3 months after randomization followed by testing with CxBladder 3 months thereafter.
干预措施: Cystoscopy (Diagnostic Test)
结局指标
主要结局
Preference for CxBladder Monitor compared to cystoscopy
时间窗: Up to 6 months
Patient preference will be assessed based on the Preference Questionnaire (PQ) after completion of the study cross-over period (after both methods of testing have been experienced).
次要结局
- Patient satisfaction(Up to 6 months)
- Change in symptoms and function - EORTC NMIBC-24(Up to 6 months)
- Error rate identifying recurrent nonmuscle invasive bladder cancer (NMIBC)(Up to 6 months)
- Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF)(Up to 6 months)
- Financial costs(Up to 6 months)
研究者
Mark D. Tyson II, M.D., M.P.H.
Principal Investigator
Mayo Clinic