Optimal Screening Strategy for Bladder Cancer in at Risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Incidence of Bladder cancer (BCa)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smoking: ≥15 pack-year smoking history
- •Occupation:≥ 15 years of occupational exposures including: textile worker, painter, dry cleaners
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Urinalysis (Diagnostic Test)
Historical Control Group
This will include historical control (bladder cancer detected in patients by standard of care) using SEER registries).
结局指标
主要结局
Incidence of Bladder cancer (BCa)
时间窗: 5 years
Incidence of Bladder cancer is measured by the number of participants who were detected with BCa.
次要结局
- Smoking cessation(3 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)
- Screening interval(approx. every 6 months for up to 2 years)
研究者
yair lotan
Professor-Urology
University of Texas Southwestern Medical Center