Can less frequent bladder cancer checkups be just as safe?
NCT ID NCT07408830
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether veterans with early-stage high-grade bladder cancer can have fewer follow-up exams (cystoscopies) without harming their health. About 2,500 participants will be randomly assigned to either a low-intensity or high-intensity surveillance schedule. The goal is to see if less frequent checkups are safe and effective for managing the disease over many years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 2,482 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Jan 2037
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 carcinoma. Participants who had a resection of a recurrent urothelial carcinoma are eligible if they meet inclusion / exclusion criteria. * 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 Notes: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, 05001-3833, United States
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