CSP #2036 - VA Randomized Trial of Surveillance Intervals After Transurethral Resection of High-Grade Bladder Tumors (VATSIT)
VA Office of Research and Development
Summary
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.
Description
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 proced…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- OtherLow 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
- OtherHigh 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.
Location
- White River Junction VA Medical Center, White River Junction, VTWhite River Junction, Vermont