Recruiting

Bladder Cancer

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05646485

Conditions

Bladder Cancer

Urothelial Carcinoma

Hematuria

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Urinalysis

Study Details

Brief 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

Bladder Cancer

Urothelial Carcinoma

Hematuria

Smoking Cessation

Study ID

NCT05646485

Start date

May 5, 2023

Status verified date

Apr, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 50
  • Smoking: ≥15 pack-year smoking history
  • Occupation:≥ 15 years of occupational exposures including: textile worker, painter, dry cleaners

Exclusion Criteria:

  • Prior history of bladder, kidney, or prostate cancer
  • Prior evaluation of micro or gross hematuria within the last 2 years
  • Do not provide informed consent

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

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).

Interventions

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 - \[cystoscopy + Upper tract imaging\].

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Yair Lotan, MD

214-648-0389yair.lotan@UTsouthwestern.edu

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Sonobia Garrett

214-645-8787

Principal Investigator:

Yair Lotan, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-05-01.