Determining the Specificity and Sensitivity of the BladderLight™ Assay as a Diagnostic and Risk Stratification Tool for Bladder Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 2,100
- 主要终点
- To exclude presence of bladder cancer with sensitivity of 85%
研究概览
简要总结
Is BladderLight® (BL) urine testing accurate, as a non-invasive method, to exclude presence of bladder cancer in patients.
详细描述
There are three arms to the proposed performance evaluation of the integrated test - arms 1 and 2 are cross-sectional studies examining the accuracy of the BladderLight® test in the detection of cancer of the urinary bladder in patients attending either Gross Haematuria clinic for a potential primary (first time) diagnosis (arm 1) or patients attending Cystsoscopic Surveillance clinic as follow up to a previous, treated case of bladder cancer (arm 2). Arm 3 is a longitudinal examination of disease state following a negative cystoscopy with a positive BladderLight® test - this will examine whether BladderLight® can predict progression to overt disease. Arm three will not involve any further requirement for physical sampling, but will involve result checking on subsequent cystoscopies
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
- Diagnostic
- 盲法
- None
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
- •Aged 18 years of age or above.
- •Patients attending Cystoscopic Surveillance clinic for monitoring of recurrence of urothelial carcinoma after having been treated for urothelial carcinoma / bladder cancer (Arm 1) OR Patients attending Gross Haematuria clinic (or equivalent) for cystoscopy/biopsy (if appropriate) relating to symptoms suggestive of possible urothelial cancer (Arm 2). Patients that will receive a cystoscopy as per standard practice.
- •Able to understand and sign the written Informed Consent Form.
- •Able and willing to follow the Protocol requirements
排除标准
- •Participation in any clinical study of an Investigational Medicinal Product during the 8 weeks preceding the sampling period of the study.
- •Patients that have a urinary tract stent, kidney stones or catheter
研究组 & 干预措施
Cystoscopic surveillance
Patients with previous history of bladder cancer undergoing flexible cystoscopy will privide a urine sample to see if BladderLight system can exclude presence of bladder cancer
干预措施: BladderLight® (Device)
Haematuria group
Patients referred with haematuria to exclude bladder cancer will privide a urine sample to see if BladderLight system can exclude presence of bladder cancer
干预措施: BladderLight® (Device)
Longitudinal group
Patient with Negative cystoscopy with a positive BladderLight® test will be followed for 12 months to see if they subsequently develop bladder cancer.
结局指标
主要结局
To exclude presence of bladder cancer with sensitivity of 85%
时间窗: 12 month
In each cohort of the study sensitivity, specificity, negative and positive predictive value for detection of cancer will be calculated.
次要结局
未报告次要终点
研究者
Kasra Saeb-Parsy BSc, MB BS, AFHEA, FRCSEd (Urol)
Consultant Urologist, Chief Investigator
Cambridge University Hospitals NHS Foundation Trust