NCT05151341已完成不适用
Evaluation of a Urine Analysis Combining VisioCyt® Automated Cytology and FGFR3 Mutations for the Detection of Bladder Cancer
Institut de Cancérologie de Lorraine2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2021年12月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Specificity
研究概览
简要总结
This study is a case-control, propsective and muticentric clinical trial, which aim to compare the specificity and sensibility of VisioCyt urinary cytological test combined with FGFR3 mutation detection test to VisioCyt urinary cyological test on its own to detect bladder cancer.
The case are patient in whom newly diagnosed, or recurring /progressing bladder cancer is strongly suspected after initial fibroscopy.
The control are patient attending or hospitalized for urolithiasis, urinary infections, urinary superior excretory stones or with non suspect urinary symptomatology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •BOTH GROUPS
- •Patient agrees to follow study protocol and is able to follow study procedures
- •Patient signed, dated and understood consent form
- •Patient has a social security scheme
- •Patient is 18 or older
- •Patient for whom a bladder cancer recently diagnosed, or backsliding/progression is heavily suspected after the initial fibroscopy
- •Patient who hasn't started systemic/oral/radiotheurapeutic pelvic treatment for his/her tumor
- •CONTROL GROUP
- •Patient between 18 and 45 y/o
- •Patient not suspected of having any bladder cancer
- •Patient attending or hospitalized for urolithiasis, urinary infections, superior excretory stones or with non suspect urinary symptomatology
- •Patient who hasn't been exposed to bladder carcinogens (tobacco, industrial carcinogen (ex: coal tar, tar/coal oils, coal pitch and burning coal soot), urinary bilharzia, chemotherapy exposition (cyclophosphamid)
- •Patient that had a negative cytopathological exploration of the excretory urinary route OR/AND iconography (pelvic echography, pelvic scanner) OR/AND endoscopy with prior urinary sample
- •Patient unscathed of any cancer that might interact with bladder cancer : uterine cancer, prostate cancer, rectal cancer, and metastasis from other cancer or non-urologic tumor invading the bladder
排除标准
- •BOTH GROUPS
- •Non-treated current urinary infection
- •Patient with another pelvic cancer
- •Bladder cancer outside of urothelial carcinoma
- •Associated carcinoma of the high urinary apparatus
- •Patient that received renal transplantation (BK virus)
- •Patient that received pelvis radiotherapy (related to prostatic cancer, gynecologic cancer or pelvic digestive cancer)
- •Patient having a JJ catheter
- •Refused to signed consent
- •Pregnant, susceptible to be, or breast-feeding women
- •Person Under guardianship
- •Impossibility to submit to medical monitoring because of geographic, social, or mental issues
- •CASE GROUP • Under 18y/o
- •CONTROL GROUP
- •Under 18y/o or above 45 y/o
结局指标
主要结局
Specificity
时间窗: at inclusion
Specificity comparaison between Visiocyt test + FGFR3 analysis and FGFR3 analysis on its own
次要结局
- Specificity of the 4 different tests(at inclusion)
- Positive predictive value of the 4 different tests(at inclusion)
- Sensitivity of the 4 different tests(at inclusion)
- Negative predictive value of the 4 different tests(at inclusion)
研究者
研究点 (2)
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