Surveillance Intervals for Bladder Cancer
(VATSIT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the best way to monitor veterans with high-grade non-muscle invasive bladder cancer. Participants will be randomly assigned to either low-intensity or high-intensity surveillance, involving different frequencies of cystoscopy (a procedure to look inside the bladder) and urine tests. The goal is to determine which approach more effectively detects cancer recurrence. Veterans who recently had a bladder tumor removed and show no signs of cancer in their first follow-up check may be suitable for this study. As an unphased trial, this study offers veterans the opportunity to contribute to research that could enhance future cancer monitoring strategies.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. Treatment for bladder cancer will be decided by your VA clinician, so it's best to discuss your medications with them.
What prior data suggests that these surveillance intervals are safe for bladder cancer patients?
Research has shown that low-intensity monitoring for bladder cancer is generally safe. In a study of 1,542 patients with high-risk non-muscle invasive bladder cancer (NMIBC), 520 patients followed a low-intensity monitoring plan. This approach did not increase the risk of dying from bladder cancer compared to more frequent monitoring. Patients on low-intensity plans also required fewer surgeries, with 37 surgeries per 100 person-years compared to 99 for those on high-intensity plans.
Overall, low-intensity monitoring appears well-tolerated and does not raise the risk of serious outcomes like death from bladder cancer. These findings suggest that this option is safe for those considering it.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores different surveillance strategies for bladder cancer, potentially impacting patient care significantly. Current standard protocols involve frequent cystoscopies and urine tests, which can be invasive and inconvenient. The trial compares high-intensity surveillance, which aligns with current guidelines, to low-intensity surveillance, which reduces testing frequency over time. If low-intensity surveillance proves effective, it could lead to less invasive, more patient-friendly care without compromising outcomes. This could mean fewer hospital visits and a better quality of life for patients managing bladder cancer.
What evidence suggests that this trial's surveillance methods could be effective for bladder cancer?
This trial will compare high-intensity and low-intensity surveillance for bladder cancer. Research has shown that for high-grade non-muscle invasive bladder cancer, a low-intensity monitoring approach results in fewer surgeries, such as tumor removals. Specifically, patients underwent 37 surgeries per 100 person-years compared to 99 with more intensive methods. Studies indicate that this approach does not increase the risk of cancer progression or mortality. Many patients under low-intensity monitoring continue to do well over time, suggesting it can be a safe and effective way to monitor bladder cancer without frequent invasive procedures.12456
Who Is on the Research Team?
Florian R Schroeck, MD MS
Principal Investigator
White River Junction VA Medical Center, White River Junction, VT
Are You a Good Fit for This Trial?
This trial is for veterans who've had high-grade non-muscle invasive bladder cancer and a recent TURBT procedure. They must have completed their first cystoscopy post-surgery without issues. The study excludes those with certain conditions or treatments that could interfere with the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization and Initial Surveillance
Participants are randomized to either low- or high-intensity surveillance programs after a normal first cystoscopy post-TURBT
Surveillance
Participants undergo surveillance cystoscopy and urine cytology testing according to their assigned intensity program
Extended Surveillance
Surveillance continues with less frequent visits, every 6 months up to 48 months, then annually
Follow-up
Participants are monitored for long-term outcomes, with data collection via phone or health record review
What Are the Treatments Tested in This Trial?
Interventions
- High Intensity Surveillance
- Low Intensity Surveillance
Trial Overview
The study compares two monitoring approaches after bladder tumor surgery: 'Low Intensity Surveillance' versus 'High Intensity Surveillance'. Participants will be randomly assigned to one of these groups, and outcomes will be checked by blinded assessors to reduce bias.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Citations
versus high-intensity surveillance cystoscopy on surgical care ...
Patients undergoing low-intensity surveillance had fewer transurethral resections (37 vs. 99 per 100 person-years; p<0.001). Risk of death from ...
Low-Intensity Surveillance Demonstrates Utility in NMIBC
Patients who had low-intensity cystoscopy surveillance underwent fewer transurethral resections but did not experience an increased risk of ...
Low-Grade Non–Muscle-Invasive Bladder Cancer and the ...
Low-grade NMIBC has been established to be indolent in nature, with excellent 15-year progression-free survival (95%) and cancer-specific ...
4.
renalandurologynews.com
renalandurologynews.com/news/low-intensity-surveillance-cystoscopy-safe-high-risk-nmibc/Low-Intensity Surveillance for High-Risk NMIBC Safe, Data ...
Patients in the low-intensity group had significant fewer transurethral resections (37 vs 99 per 100 person-years). At 5 years, the percentage ...
Surveillance guidelines for low grade non-invasive bladder ...
Approximately half of all incident bladder tumors are low grade, noninvasive (LGTa), with moderate recurrence risk and rare progression to muscle-invasive ...
versus high-intensity surveillance cystoscopy on surgical care ...
Patients undergoing low-intensity surveillance had fewer transurethral resections (37 vs. 99 per 100 person-years; p<0.001). Risk of death from ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.