Surveillance for Low and Low-Intermediate Risk Non-muscle Invasive Bladder Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Demonstrate feasibility of study recruitment and retention in order to help plan for subsequent phase III study.
研究概览
简要总结
This is a two-arm, randomized-controlled pilot study with 2 year duration. The "intervention" refers to surveillance based on the European Association of Urology (EAU) guidelines and the "control" refers to surveillance based on the American Urological Association (AUA) guidelines.
详细描述
This is a two-arm, randomized-controlled pilot study with 2 year duration. The "intervention" refers to surveillance based on the EAU guidelines and the "control" refers to surveillance based on the AUA guidelines.
Research methods: Participants who presents with non-muscle invasive bladder cancer and meets the inclusion/exclusion criteria will be given an option to participate in the study. Participants will be enrolled at the Urology Clinics at the University of Texas Health Science Center San Antonio (UTHSCSA) Medical Arts and Research Center (MARC) and South Texas Veterans Health Care System (STVHCS). Non-local site include the University of Texas Southwestern Medical Center (UTSW). The research procedures consist of urine collection, cystoscopy, and patient satisfaction and cost questionnaires. The evaluation will be done by the tumor recurrence and progression of the disease. At various time points throughout the study, urine may be obtained from the patient and banked in the Genitourinary (GU) Tissue Bank. Subjects asked to provide a urine sample(s) will be asked to sign a separate informed consent. The urine is de-identified in the lab per the Health Insurance Portability and Accountability Act (HIPAA) protocol GU Tissue Bank Institutional Review Board (IRB) # 20050234H). Patients will undergo cystoscopy in clinic (standard of care). In the intervention arm, patient surveillance cystoscopy will be performed at 3, 12 months and again at 24 months following the diagnosis of bladder cancer. Patients randomized to the control arm, will undergo surveillance cystoscopy every 3 months for 2 years following the diagnosis of bladder cancer. Because use of cytology is variable among the participating urologist, the utilization of cytology will be at the treating urologist's discretion as per usual standard care. Study duration will be 2 years from most recent biopsy. Patients will be placed on the surveillance schedule based on the length of time from their last tumor.
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
- •Must have non-muscle invasive low-grade, papillary (Ta) bladder cancer.
- •Must have a negative cystoscopy following most recent biopsy.
- •Must be able to give informed consent.
- •Must be age 18 or older.
- •Must be at low- or low-intermediate risk for disease recurrence and progression according to the EAU guidelines.
排除标准
- •Have a history of invasive (>=T1) bladder cancer.
- •Have a history of carcinoma-in-situ (CIS).
- •Unable to give informed consent.
- •< 18 or younger.
- •Variant histology (micropapillary, nested variant, non-urothelial cell carcinoma elements).
- •Had a surveillance cystoscopy following most recent biopsy.
结局指标
主要结局
Demonstrate feasibility of study recruitment and retention in order to help plan for subsequent phase III study.
时间窗: 2 years
Develop methods for assessing patient satisfaction and costs associated with cystoscopy during bladder cancer surveillance.
时间窗: 2 years
次要结局
- Capture preliminary data regarding number of procedures and direct and indirect cost differences between study arms.(2 years)
- Compare proportion of patients experiencing disease progression and recurrence at 2 years following most recent biopsy under two different surveillance approaches.(2 years)