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Bladder Cancer Screening Trial

NCT05646485 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-05-01

No results posted yet for this study

Summary

There is currently no accepted screening strategy for patients at high risk of developing bladder cancer. This study will ask patients to complete a urine test every 6 months for 2 years to help assess if routine screening helps finding bladder cancer at an earlier stage.

Conditions

Interventions

DIAGNOSTIC_TEST

Urinalysis

Urine analysis (every 6 months for 2 years); Patients with \<3 red blood cells (RBCs) per high-powered field (HPF) will repeat screening at 6-month intervals for an average of 2 years. If RBCs are 3-25 RBSc/HPF- subjects will undergo- \[cystoscopy + Upper tract imaging\] or \[urine marker cancer testing with Cxbladder triage + Upper tract imaging\]. If \>25 RBCs, subjects will get - \[cystoscopy + Upper tract imaging\].

Sponsors & Collaborators

  • Wilson Charitable Foundation Trust

    collaborator UNKNOWN

  • Pacific Edge Limited

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Yair Lotan, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-05
Primary Completion
2027-04-30
Completion
2028-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05646485 on ClinicalTrials.gov