A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 14
- 主要终点
- Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.
研究概览
简要总结
To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.
详细描述
Hematuria is the most common presentation of BCa with 8% of patients with microscopic hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Because of this severe limitation, patients with hematuria will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder.
We propose to improve the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Have documented or reported microscopic hematuria within 3 month of study enrollment
- •Willing and able to give written informed consent
排除标准
- •(participants must not):
- •Have history of BCa
- •History of previous cancer (excluding basal and squamous cell skin cancer)
- •Have a known active urinary tract infection or urinary retention
- •Have active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0 mg/dL)
- •Have ureteral stents, nephrostomy tubes or bowel interposition
- •Have recent genitourinary instrumentation (within 10 days prior to signing consent)
- •Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)
结局指标
主要结局
Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.
时间窗: 1 year
次要结局
- Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek.(1 year)
研究者
Charles Rosser
Professor
Cedars-Sinai Medical Center