Bladder Cancer Screening Trial

NCT05646485 | Recruiting FDA Device

• 1 other identifier: STU-2022-1042
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Bladder cancer (BCa)

  Incidence of Bladder cancer is measured by the number of participants who were detected with BCa.

  5 years

Secondary Outcomes (4)

• Smoking cessation

  3 years

• Screening interval

  approx. every 6 months for up to 2 years

• Screening interval

  approx. every 12 months for up to 2 years

• Number of participants with positive/ negative markers and findings on cystoscopy

  2 years

Study Arms (2)

BCa Early Screening Group

EXPERIMENTAL

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).

Diagnostic Test: Urinalysis

Historical Control Group

NO INTERVENTION

This will include historical control (bladder cancer detected in patients by standard of care) using SEER registries).

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 - \[cystoscopy + Upper tract imaging\].

BCa Early Screening Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wilson Charitable Foundation Trust: collaborator
• University of Texas Southwestern Medical Center: lead
• Pacific Edge Limited: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Hematuria; Smoking Cessation

Interventions

Urinalysis

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Urination Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Investigative Techniques

Study Officials

• Yair Lotan, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yair Lotan, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Urology

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 12, 2022
• Study Start: May 5, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)