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Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection

RECRUITINGPhase 3Sponsored by Johns Hopkins University
Actively Recruiting
PhasePhase 3
SponsorJohns Hopkins University
Started2024-12-20
Est. completion2027-01-04
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites

Summary

Comparing white-light cystoscopy (WLC) and blue-light cystoscopy (BLC) in TURBT for high risk (HR) non-muscle invasive bladder cancer (NMIBC) patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival. Enhanced visualization with BLC may lead to more accurate resections, potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients. Patients will be randomized to either WLC TURBT or BLC TURBT, and outcomes will be measured using standard-of-care testing with cystoscopy and cytology, along with minimal residual disease (MRD) burden evaluation using urine next-generation sequencing.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Patients undergoing TURBT for radiographic or cystoscopic positive tumor
* 18+ years old
* Upper tract evaluated using standard of care throughout duration of the study
* Induction intravesical therapy initiated within four weeks of TURBT

Exclusion Criteria:

* Variant histology consisting of less than 50% urothelial carcinoma
* History, or current diagnosis, of upper tract tumor or muscle-invasive bladder cancer
* Prior history of pelvic radiation
* Active urinary tract infection (UTI)
* Patients who are noncompliant with the study protocol

Conditions2

Bladder CancerCancer

Locations2 sites

District of Columbia

1 site
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016

Maryland

1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Rana Harb410-502-5500rharb1@jhmi.edu

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