Bladder Cancer Screening Trial

Optimal Screening Strategy for Bladder Cancer in at Risk Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Bladder Cancer; Urothelial Carcinoma; Hematuria
• Intervention / Treatment: Diagnostic test: Urinalysis

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).

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yair Lotan, MD; Phone Number: 214-648-0389; Email: yair.lotan@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center
      • Principal Investigator: Yair Lotan, MD
      • Contact: Sonobia Garrett; Phone Number: 214-645-8787

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Historical Control Group; This will include historical control (bladder cancer detected in patients by standard of care) using SEER registries).
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).	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].

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Bladder cancer (BCa)	Incidence of Bladder cancer is measured by the number of participants who were detected with BCa.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking cessation	Smoking cessation is measured by number of participants who were referred to smoking cessation treatment	3 years
Screening interval	Screening interval is assessed by calculating the average screening interval from baseline until the timepoint when RBCs >3 are detected for each participant	approx. every 6 months for up to 2 years
Screening interval	Screening interval is assessed by calculating the average screening interval from baseline until the timepoint when RBCs >3 are detected for each participant	approx. every 12 months for up to 2 years
Number of participants with positive/ negative markers and findings on cystoscopy	Performance of urinalysis and molecular markers is assessed by the count of participants with positive/ negative markers and findings on cystoscopy	2 years

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Yair Lotan, MD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Hemorrhage; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Hematuria
• Other Study ID Numbers: STU-2022-1042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No