Clinical trial NCT05646485: Bladder Cancer Screening Trial
Official title: Optimal Screening Strategy for Bladder Cancer in at Risk Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Urothelial Carcinoma
Hematuria
Smoking Cessation
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Wilson Charitable Foundation Trust
name: Pacific Edge Limited
First posted: 2022-12-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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).

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

Primary outcomes:
measure: Incidence of Bladder cancer (BCa)
timeFrame: 5 years
Secondary outcomes:
measure: Smoking cessation
timeFrame: 3 years
measure: Screening interval
timeFrame: approx. every 6 months for up to 2 years
measure: Screening interval
timeFrame: approx. every 12 months for up to 2 years
measure: Number of participants with positive/ negative markers and findings on cystoscopy
timeFrame: 2 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Yair Lotan, MD
role: PRINCIPAL_INVESTIGATOR
References: