Bladder Cancer Screening Trial

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05646485
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Urinalysis — DIAGNOSTIC_TEST
    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 - \[cystoscopy + Upper tract imaging\].

Study Details

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.

Key Dates

Start date
May 5, 2023
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: BCa Early Screening Group
    All participants undergo Urinalysis testing every 6 months for 2 years. Based on the RBC count, each participant will go through each of the screening procedures : \[cystoscopy + Upper tract imaging\] or \[urine marker cancer testing with Cxbladder triage + Upper tract imaging\] or \[Repeat urinalysis\] Patients with suspicious findings on cystoscopy or imaging will get treatment as per standard of care. Their outcomes will be compared to a historical control (bladder cancer detected by standard of care using SEER registries).
  • No Intervention: Historical Control Group
    This will include historical control (bladder cancer detected in patients by standard of care) using SEER registries).

Primary Outcome Measure

Incidence of Bladder cancer (BCa) [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Sonobia Garrett
214-645-8787
Yair Lotan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dallas, TX

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
University of Texas Southwestern Medical Center· Dallas, TX

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