A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.
研究概览
简要总结
Voided urinary cytology (VUC) is the most widely used urine-based assay for detecting bladder cancer (BCa); however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Furthermore, the detection rate of VUC for recurrent BCa is not much better. Because of this severe limitation, all patients who are under surveillance to monitor for recurrent BCa must undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder and the bladder inspected (cystoscopy). We propose to improve the non-invasive detection of recurrent BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be:
- •Age 18 years or older
- •Have a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated) and diagnosed within the past 24 months on cystoscopic surveillance
- •Participants may be treated with adjuvant intravesical therapy
- •Willing and able to give written informed consent (see Appendix 1)
- •Be willing to adhere to the surveillance regimen (high risk and intermediate risk seen every 3 months for 2 years; low risk seen every 6-12 months for 2 years)
排除标准
- •Participants must not:
- •Have had radical cystectomy
- •History of previous cancer (excluding bladder, basal and squamous cell skin cancer) within the past 3 years
- •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) - Serum creatinine value can be up to 60 days before consent, otherwise repeat.
- •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 surveillance regimen
结局指标
主要结局
Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.
时间窗: 2 years
To examine the sensitivity and specificity of the multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples to reference standard of cystoscopy in a prospective longitudinal cohort of 300 participants with a history of BCa currently on cancer surveillance.
次要结局
- Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP22 BladderCheck.(2 years)
研究者
Charles Rosser
Professor
Cedars-Sinai Medical Center