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Study of Surveillance Intervals for High-Grade Bladder Cancer

This study is for Veterans with high-grade early-stage bladder cancer who have recently had a procedure to remove bladder tumors. It's looking at whether less frequent check-ups (surveillance) are as effective as more frequent ones. You would be randomly assigned to one of two groups: "Low Intensity Surveillance" with cystoscopy (a procedure to look inside the bladder) once a year and urine tests every 3-6 months, or "High Intensity Surveillance" with cystoscopy and urine tests every 3-6 months, then annually. The main goal is to see if overall survival (how long people live) is similar between the two groups over an average of 7 years. This study aims to find out if we can reduce the number of invasive procedures for patients without affecting their health outcomes.

Study design
This is a randomized study comparing two different surveillance schedules for bladder cancer. About 2,482 participants will be involved, and while staff and participants won't be blinded, the results will be reviewed by people who don't know which group you were in.
What's involved
You would undergo either low-intensity surveillance (cystoscopy annually, urine tests every 3-6 months) or high-intensity surveillance (cystoscopy and urine tests every 3-6 months, then annually). The study plans for an average follow-up of 7 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for an estimated average of 7 years, with a maximum follow-up of 10 years, to measure overall survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07408830

VA Randomized Trial of Surveillance Intervals After Transurethral Resection of High Grade Bladder Tumors

Not Yet Recruiting
NAAges 18+InterventionalTreatment
VA Office of Research and Development
~2,482 participants
Updated 2026-02-13 on ClinicalTrials.gov
What's tested:Low Intensity SurveillanceHigh Intensity Surveillance

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival
Measured over Varying timeframe for each participant. Estimated average follow-up of 7 years with a maximum follow-up of 10 years.

Conditions

High-Grade Early-Stage Bladder Cancer

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NCT07408830

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • White River Junction VA Medical Center, White River Junction, VT

    White River Junction, Vermontstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Florian R Schroeck, MD MS · STUDY_CHAIR · White River Junction VA Medical Center, White River Junction, VT

Who to contact

Florian R Schroeck, MD MS
[email protected]
(802) 295-9363 · ext. 4312
Email the study team

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Eligibility criteria

Inclusion

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)
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

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

What this trial measures

  • Overall SurvivalVarying 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.