Surveillance for Low and Low-Intermediate Risk Non-muscle Invasive Bladder Cancer: A Pilot Study
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Texas
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San Antonio、Texas、美国、78229
- The University of Texas Health Science Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Intervention
The intervention group refers to surveillance based on the EAU guidelines.
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Patients randomized into the intervention group will follow the European Urologic Association (EAU) surveillance guidelines for cystoscopy follow-ups during bladder cancer surveillance.
其他名称:
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Control
The control group refers to surveillance based on the AUA guidelines.
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Patients randomized into the control group will follow the American Urologic Association (AUA) surveillance guidelines using cystoscopy ever 3 months for the first two years, and then every 6 months for 2 years.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Demonstrate feasibility of study recruitment and retention in order to help plan for subsequent phase III study.
大体时间:2 years
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2 years
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Develop methods for assessing patient satisfaction and costs associated with cystoscopy during bladder cancer surveillance.
大体时间:2 years
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2 years
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次要结果测量
结果测量 |
大体时间 |
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Capture preliminary data regarding number of procedures and direct and indirect cost differences between study arms.
大体时间:2 years
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2 years
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Compare proportion of patients experiencing disease progression and recurrence at 2 years following most recent biopsy under two different surveillance approaches.
大体时间:2 years
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2 years
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Intervention的临床试验
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动,不招人