Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
ID05646485

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

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

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

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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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