Bladder Cancer Screening Trial

NCT ID: NCT05646485

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-05
• Study Completion Date: 2028-04-30

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.

Detailed Description

Bladder cancer is the 4th most common cancer in men and 6th most common cancer overall with over 80,000 new cases in the US per year. The most common causes of bladder cancer are smoking and it is usually found in patients over the age of 50. By the time it is diagnosed, the disease is often advanced since there are few warning signs other than seeing blood in the urine.

Screening is currently accepted practice for colon, cervical, and breast cancer. However, there is not an accepted screening methodology for bladder cancer. Bladder cancer is currently detected in 2-5% of patients who have microhematuria on routine urinalysis, a cheap, non-invasive test obtained by many primary care physicians. Bladder cancer diagnosed by microscopic blood on urinalysis is often lower stage than patients diagnosed with visible blood. Urine testing, therefore, offers a simple screening mechanism that can be tailored to patients at higher risk for bladder cancer based on age, tobacco exposure and other risk factors. In conjunction with routine traditional urinalysis testing, there are advances in urine molecular markers which utilize protein and genetic alterations resulting in a higher sensitivity and specificity for the detection of bladder cancer. Markers have not been evaluated for screening in high-risk populations, and there is a gap in knowledge of the most accurate screening method.

Early detection of bladder cancer has the potential to identify disease at an earlier stage resulting in a lower burden of treatment, improved quality of life, and improved survival.

This study will prospectively screen patients at high risk for the development of bladder cancer at bi-annual intervals with a commonly available urinalysis test that assess for microhematuria and urine based molecular markers.

This is a single arm study. The outcomes from the experimental arm will be compared to a historical control (bladder cancer detected by standard of care using SEER registries).

Conditions

Bladder Cancer; Urothelial Carcinoma; Hematuria; Smoking Cessation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Urinalysis

Intervention Type: 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].

Historical Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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].

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wilson Charitable Foundation Trust

UNKNOWN

Sponsor Role: collaborator

Pacific Edge Limited

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

yair lotan

Professor-Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yair Lotan, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yair Lotan, MD

Role: CONTACT

yair.lotan@UTsouthwestern.edu

214-648-0389

Facility Contacts

Sonobia Garrett

Role: primary

214-645-8787

Other Identifiers

STU-2022-1042

Identifier Type: -

Identifier Source: org_study_id