CSP #2036 - VA Randomized Trial of Surveillance Intervals After Transurethral Resection of High-Grade Bladder Tumors (VATSIT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,482
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
CSP #2036 is a pragmatic, randomized, intent-to-treat, two-arm, parallel, multicenter CSP trial. Blinding of clinical staff and participants will not be possible. However, outcomes will be adjudicated by assessors blinded to randomization arm to minimize bias. Due to the pragmatic nature of the study, treatment for bladder cancer will be at the discretion of the VA participants' clinicians, and all treatments will be recorded.
Veterans with high-grade non-muscle invasive bladder cancer who underwent biopsy or transurethral resection of a bladder tumor (TURBT) in the prior 6 months will be invited to participate. After a normal first cystoscopy after TURBT (also known as "3-month cystoscopy") and additional screening, participants will be randomized 1:1 to a program of low- vs high-intensity surveillance. Stratification by stage (2 groups: Ta only vs. any T1 / any Carcinoma in situ), and site will be done because these may influence other bladder cancer-specific care, such as the threshold of when to biopsy a possible bladder lesion and whether to administer intravesical therapy.
Outcomes will be assessed during study visits every three months for 24 months, every six months after that up to 48 months, and at 60 months. Follow-up data collection beyond 60 months will be completed by phone call or participants' health record review. This will be a 10-year study with 6 years dedicated to recruitment and a minimum of 4 years dedicated to follow-up. Thus, estimated average follow-up will be 7 years and maximum follow-up will be 10 years.
详细描述
Background: This CSP study is designed to disrupt the paradigm of high-intensity surveillance with invasive cystoscopy procedures for participants with high-grade early-stage bladder cancer that has existed for more than 80 years without high-quality evidence. Bladder cancer is the third most prevalent non-cutaneous cancer in VA with approximately 30,000 Veterans living with the disease. These ~30,000 Veterans undergo regular surveillance cystoscopy procedures every 3 to 4 months - usually combined with non-invasive urine cytology testing. This makes cystoscopy the most common surgical procedure performed in VA with more than 80,000 procedures annually.
There is a significant gap in knowledge as there is no high-quality data linking high-intensity surveillance with invasive cystoscopy procedures to outcomes. While recommended in guidelines, the 3-month time interval is due to historical precedent dating back to 1936. Thus, there is an urgent need for studies to determine if low-intensity surveillance with fewer cystoscopy procedures can be employed without significantly affecting important outcomes.
Low-intensity surveillance with fewer cystoscopy procedures has a number of potential benefits. It could spare Veterans up to 60% of the currently scheduled invasive cystoscopy procedures, substantially decreasing morbidity and discomfort associated with these procedures. For the VA healthcare system, substantial cost-savings could be achieved if the number of cystoscopy procedures could be reduced without impacting outcomes that matter to participants and clinicians.
This study is the first and only study comparing high-intensity surveillance with frequent cystoscopy to low-intensity surveillance with fewer cystoscopy procedures among participants with high-grade early-stage bladder cancer. It will provide critical data on how surveillance schedules affect important outcomes. Thus, the results of the study will impact VA, national, and international guideline recommendations on surveillance cystoscopy.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Both participants and investigators will be unblinded to the intervention assignment due to the nature of the interventions. Study chairs and the national study coordinator will be blinded to all outcome data, except as required to address adverse events. The study outcomes will be adjudicated by assessors blinded to randomization arms to minimize bias.
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
- •VA patients with a history of high-grade non-muscle invasive urothelial carcinoma of the bladder (Inclusion of non-Veterans only allowed if they already receive clinical care at a VA medical center, e.g., via the CHAMPS program)
- •Local pathology report from recent biopsy or resection confirming high-grade non-invasive urothelial carcinoma (high-grade stage Ta), high-grade urothelial carcinoma with invasion into the subepithelial connective tissue (high-grade stage T1), or carcinoma in situ (stage CIS) Note: Participants do not have to have a new diagnosis of urothelial carcinoma. Participants who had a resection of a recurrent urothelial carcinoma are eligible if they meet inclusion /
排除标准
- •Bladder cancer treatment since recent biopsy or resection that is in line with VA National Oncology Bladder Cancer Clinical Pathway (e.g., underwent re-resection of T1 disease, administration of intravesical therapy if indicated, or documented reason why Pathway was not followed)
- •No evidence of bladder cancer recurrence at first surveillance cystoscopy after most recent resection or biopsy showing urothelial carcinoma (referred to by "3-month cystoscopy" in the protocol), defined as negative cystoscopy AND negative or atypical urine cytology
- •a re-resection TURBT performed per VA National Oncology Bladder Cancer Clinical Pathway or per local urology clinician judgement is not considered a surveillance cystoscopy. In that setting, the first cystoscopy following that re-resection TURBT will be the "3-month cystoscopy."
- •atypical cytology is not of concern in this population, as it frequently can be seen secondary to instrumentation, inflammation, or bacterial colonization.
- •Ability to consent in English or Spanish
- •Stated willingness to comply with all study procedures
- •Exclusion Criteria:
- •History of urothelial carcinoma of the ureter or renal pelvis status post endoscopic treatment or with evidence of current upper tract disease (inclusion allowed if status post nephroureterectomy and recurrence free at time of inclusion)
- •History of urothelial carcinoma of the prostate or urethra
- •History of muscle-invasive urothelial carcinoma of the bladder
- •History of pure squamous cell carcinoma of the bladder
- •Small cell carcinoma of the bladder
- •Sarcoma of the bladder
- •Urothelial carcinoma with predominantly (>50%) variant histology
- •Eastern Cooperative Oncology Group (ECOG) performance status of 3 (capable of only limited selfcare; confined to bed or chair more than 50% of waking hours) or 4 (completely disabled; cannot carry out any selfcare; totally confined to bed or chair)
- •Unable to follow-up for planned minimum of 5 years (e.g., pending move away from their VA site, unless planned move is to another VATSIT study site)
- •Imaging concerning for metastatic urothelial carcinoma
- •Anatomic constraints that make standard cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture)
- •Known pregnancy at the time of study enrollment (routine pregnancy testing is not required)
- •Dual enrollment in an interventional drug or device study
研究组 & 干预措施
Low Intensity Surveillance
Participants assigned to low-intensity surveillance will undergo cystoscopy 12 months after transurethral resection, and then annually. They will also undergo non-invasive testing in the form of urine cytology every 3 months until month 24 after transurethral resection, then every 6 months until month 48, then annually
干预措施: Low Intensity Surveillance (Other)
High Intensity Surveillance
Participants assigned to high-intensity surveillance will undergo cystoscopy and urine cytology testing every 3 months until month 24 after transurethral resection, then every 6 months until month 48, then annually. This is the currently accepted surveillance schedule according to national guidelines and the VA National Oncology Bladder Cancer Clinical Pathway.
干预措施: High Intensity Surveillance (Other)
结局指标
主要结局
Overall Survival
时间窗: Varying timeframe for each participant. Estimated average follow-up of 7 years with a maximum follow-up of 10 years.
Time to death will be calculated from the most recent bladder biopsy or resection showing urothelial carcinoma prior to enrollment.
次要结局
- Bladder Cancer-Specific Survival(Varying timeframe for each participant. Estimated average follow-up of 7 years with a maximum follow-up of 10 years.)
- Radical Treatment(4 years)