Bladder Cancer, Urothelial Carcinoma, Hematuria, Smoking Cessation
Conditions
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).
Interventions
DIAGNOSTIC_TESTUrinalysis
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 - \[cystoscopy + Upper tract imaging\].
Sponsors
Wilson Charitable Foundation Trust
Pacific Edge Limited
University of Texas Southwestern Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Bladder cancer (BCa) | 5 years | Incidence of Bladder cancer is measured by the number of participants who were detected with BCa. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smoking cessation | 3 years | Smoking cessation is measured by number of participants who were referred to smoking cessation treatment |
| Screening interval | approx. every 6 months for up to 2 years | Screening interval is assessed by calculating the average screening interval from baseline until the timepoint when RBCs \>3 are detected for each participant |
| Number of participants with positive/ negative markers and findings on cystoscopy | 2 years | Performance of urinalysis and molecular markers is assessed by the count of participants with positive/ negative markers and findings on cystoscopy |
Countries
United States
Contacts
Primary ContactYair Lotan, MD
Outcome results
None listed