Actively Recruiting
Optimal Screening Strategy for Bladder Cancer in at Risk Patients
Led by University of Texas Southwestern Medical Center · Updated on 2026-05-01
1000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
W
Wilson Charitable Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Bladder cancer is a common cancer, especially among men over 50, often caused by smoking and detected late due to few early symptoms. This research aims to evaluate whether routine urine screening every six months for two years can help detect bladder cancer earlier in high-risk patients, such as those with significant smoking history or certain occupational exposures. The study is a single-arm trial comparing results to historical data from standard care. Participants will undergo urinalysis testing every six months for two years. Depending on red blood cell counts in the urine, participants may receive further screening with cystoscopy and upper tract imaging or urine marker testing with Cxbladder triage plus imaging. Those with suspicious findings will receive treatment as per standard practice. This approach is compared to historical controls from SEER registries where bladder cancer was detected by usual care. During the study, patients will complete urine tests bi-annually and may undergo additional procedures based on test results. Researchers will track bladder cancer incidence over five years and secondary outcomes like smoking cessation and screening intervals. The study includes follow-up assessments and monitoring for up to two years to evaluate the effectiveness of this screening approach compared to historical outcomes.
CONDITIONS
Brief Title
Bladder Cancer Screening Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- At least 15 pack-years smoking history
- At least 15 years of occupational exposure such as textile worker, painter, or dry cleaner
You will not qualify if you...
- Prior history of bladder, kidney, or prostate cancer
- Evaluation for micro or gross hematuria within the last 2 years
- Unable or unwilling to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants at high risk for bladder cancer are screened every 6 months using urinalysis to detect microscopic blood and urine molecular markers. Depending on red blood cell counts, additional procedures such as cystoscopy, upper tract imaging, or urine marker cancer testing may be performed.
Visits every 6 months for up to 2 years
Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
Y
Yair Lotan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
2
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