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NCT07408830 · ClinicalTrials.gov registry record · NA
VA Randomized Trial of Surveillance Intervals After Transurethral Resection of High Grade Bladder Tumors
A NA study, sponsored by VA Office of Research and Development.
- Not yet
- Registry status
- NA
- Development phase
- 2,482
- Enrollment target
NCT07408830: Clinical Trial NA study, sponsored by VA Office of Research and Development.
NCT07408830 is a NA study that has not yet begun recruiting, run by VA Office of Research and Development. The registered enrollment target is 2,482 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07408830, a NA study, has not yet begun recruiting, sponsored by VA Office of Research and Development.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 2,482 participants
- Enrollment target
Study 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.
Interventions
- OTHER Low Intensity Surveillance
- OTHER High Intensity Surveillance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,482 participants |
| Start Date | 2027-01-01 |
| Est. Completion | 2037-01-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07408830
The ClinicalTrials.gov registry entry for NCT07408830 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 2,482 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Low Intensity Surveillance is the first listed.
NCT07408830 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07408830 about?
NCT07408830 is a clinical study titled "VA Randomized Trial of Surveillance Intervals After Transurethral Resection of High Grade Bladder Tumors". 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 stud...
What is the current status of trial NCT07408830?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 2,482 participants. The study started on 2027-01-01. Estimated completion is 2037-01-01.
What interventions are being tested in trial NCT07408830?
The interventions under investigation include: Low Intensity Surveillance (OTHER), High Intensity Surveillance (OTHER).
Who is sponsoring clinical trial NCT07408830?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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