Evaluation of the Real-life Contribution of VISIOCYT Bladder Cytology in Patients With Suspected Bladder Tumor or in the Follow-up of a Bladder Tumor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 701
- 试验地点
- 1
- 主要终点
- negative predictive value
研究概览
简要总结
The study will be offered to all consecutive patients undergoing scheduled cystoscopy at the Hospitalisation De Jour (HDJ) Chirurgicale, either as part of a diagnostic approach in the event of suspected bladder tumor (exploration of macroscopic hematuria in particular), or as part of the follow-up of a bladder tumor, according to current recommendations (French ccAFU guidelines - update 2020-2022: bladder cancer).
Once non-opposition has been obtained, clinical data at the time of inclusion will be collected and pseudonymized. Urine is collected prior to cystoscopy, on voided urine, for a minimum sufficient quantity of 50 ml. The urine sample is then separated into transport jars, one of which is used for standard cytological analysis, the other for VISIOCYT cytology (sent to a laboratory platform).
In the event of a tumor or suspicious lesion detected at the cystoscopy, a trans-urethral bladder resection (TURB) will be scheduled. Anatomopathological data from this RTUV will also be collected for comparative analysis to establish the diagnostic performance of the test.
The tests performed (apart from the urine sample) are part of the usual care pathway. No additional visits will be specifically requested by the protocol. Data from examinations carried out as part of standard pathology management, or suspected pathology, will be used for this research.
At the same time, prospective questionnaires on patients' preferences with regard to the various diagnostic examinations for bladder tumours (discrete choice analysis) will be given to patients and completed at the time of cystoscopy.
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
- •Patient over 18 years of age,
- •Signed consent to participate,
- •Affiliation with a social security scheme, or beneficiary of such a scheme,
- •Patient to undergo cystoscopy for diagnosis (suspected bladder tumor) or follow-up of bladder tumor
排除标准
- •Patients managed or followed up for a bladder tumor of non-urothelial histology,
- •Renal transplant patients,
- •Patient having received pelvic radiotherapy,
- •Pregnant or potentially pregnant women (of childbearing age, without effective contraception) or nursing mothers,
- •Person in an emergency situation, adult under legal protection (guardianship, curatorship or safeguard of justice), or unable to express consent,
- •Inability to undergo medical follow-up for geographical, social or psychological reasons.
结局指标
主要结局
negative predictive value
时间窗: 1 day
negative predictive value of the VisioCyt® Bladder test. The second primary endpoint was the sensitivity of the VisioCyt® Bladder test.
次要结局
- Diagnostic performance of cystoscopy(1 day)
- Patient preference(1 day)
- Diagnostic performance - VisioCyt® Bladder test(1 day)
- Diagnostic performance - standard cytology(1 day)