跳至主要内容
临床试验/NCT04718948
NCT04718948Unknown不适用

"The Feasibility of a Multimodal Spectroscopy Analysis to Detect Urothelial Cancer in Urine"

University of Florence1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年1月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Urine Multimodal Spectroscopy Reliability

研究概览

简要总结

To facilitate the follow-up of urothelial tumors and also make them more tolerable and less invasive for patients, there is a minimally invasive and easy to perform examination which is urinary cytology on 3 samples. This test is extremely specific, over 90% chance of cancer if it is positive and is performed by expert cytopathologists, but it is burdened by a very low sensitivity, which is especially acute in the case of low grade tumors. This makes it an extremely useful test in case of positivity, but of little use if negative or doubtful, not being able to consider it reliable.

To overcome this problem, our study aims to bring an approach based on a physical principle, that is spectroscopy, which is fast non-invasive and does not require the use of additional substances or contrast media in the diagnosis of urothelial neoplasms in samples of urine.

In our experience, multimodal optical fiber spectroscopy has proved extremely valid in discriminating healthy urothelial tissue from tumor ex vivo, as well as providing important information on the degree of urothelial neoplasia, with accuracy rates higher than 80%, for which developed the idea of a technique based on multimodal spectroscopy.

If our method proves valid, it could improve the follow up and management of patients with urothelial cancer, being able to support normal cytology and provide further support to the cytopathologist, as well as simplify the diagnosis.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Urine Multimodal Spectroscopy Reliability

时间窗: Enrollment

Evaluate whether multimodal spectroscopy can discriminate between healthy controls and patients with urothelial neoplasia on urine, with an accuracy at least comparable to urinary cytology on 3 samples

次要结局

  • Urine Multimodal Spectroscopy Grading(Enrollment)
  • Urine Multimodal Spectroscopy Site Discrimination(Enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone Morselli

MD

University of Florence

研究点 (1)

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