Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,360
- 试验地点
- 21
- 主要终点
- Identification and classification of cells with the VisioCyt test to create an image processing algorithm
研究概览
简要总结
This clinical study is designed to evaluate the diagnostic performance of VisioCyt test, which would improve the early diagnosis of bladder cancer in order to optimize the management of individual patients as part of a cancer diagnostic monitoring. The diagnostic method of VisioCyt® device is based on the analysis by transmission and fluorescence, of urinary cytology slides prepared according to the protocol VisioCyt.
详细描述
This clinical trial is divided into two main phases:
I. The first one involves the construction of better image processing algorithm from a learning sample. The learning sample will include 600 virtual slides made from the urine sample of the first 600 patients enrolled.
II. The second one, will evaluate from an evaluation sample, the diagnostic performance of the test VisioCyt, to identify patients with versus without bladder tumors, using as comparator the results of the examination of reference: histology. The evaluation sample will include 400 slides, made from the urine sample of the last 400 patients enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥18 years
- •Patient affiliated to a social security system
- •Patient able to understand the protocol.
- •Signature of patient consent form before the start of the study
- •Negative urine culture
- •Patient for which is programmed a bladder Endoscopy for :
- •suspected bladder cancer (de novo, monitoring or relapse)
- •Exploration lower urinary tract excluding a suspected bladder cancer or prostate cancer
排除标准
- •Age <18 years
- •Ongoing Urinary tract infection untreated
- •Private person of liberty or under guardianship (including guardianship)
- •Bladder cancer excluding urothelial carcinoma
- •Carcinoma of high urinary tract, associated
- •Lithiasis pathology
- •Patient who underwent renal transplantation
结局指标
主要结局
Identification and classification of cells with the VisioCyt test to create an image processing algorithm
时间窗: 9 months
\* Identification and classification of cells, taking the Paris System in 2016 as a referential
Identification of presence or absence of a membrane fluorescence perished with the VisioCyt test to create an image processing algorithm
时间窗: 9 months
presence or absence of a membrane fluorescence perished, on slides
sensitivity of urinalysis by VisioCyt test
时间窗: through the study completion
number of patients "declared positive" with the VisioCyt test among the patients actually suffering from bladder carcinoma
specificity of urinalysis by VisioCyt test
时间窗: through the study completion
number of patients "declared negative" with the VisioCyt test among the really healthy patients
次要结局
- sensitivity of urinalysis by VisioCyt test according to the cell grade of the patients(through the study completion)
- sensitivity of urinalysis by VisioCyt test according to medical history of the patients(through the study completion)
- comparison of the sensitivity of the urinalysis by VisioCyt test versus conventional urine cytology(through the study completion)
- comparison of the specificity urinalysis by VisioCyt test versus conventional urine cytology(through the study completion)