NCT04718948

Multimodal Spectroscopy to Detect Urothelial Cancer in Urine

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: University of Florence · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Urothelial Carcinoma
• Urinary Bladder Cancer
• Urinary Tract Cancer

Interventions

Type	Name	Description
DEVICE	Urinary Multimodal Fiber Optic Spectroscopy	Approach based on a physical principle, mainly spectroscopy, which is rapid non-invasive and does not require the use of additional substances or contrast media in the diagnosis of urothelial neoplasms in urine samples. It will be administered through a appositely designed device
DIAGNOSTIC_TEST	Urine Cytology	An expert cytopathologist will analyze urine samples to detect urinary tract cancer cells. It is the current golden standard to detect urothelial cancer in urine
PROCEDURE	Surgery	It will provide a reliable information on the presence/absence of cancer in the urinary tract (from direct visualization to pathological analysis)

Timeline

• Start date: 2021-01-28
• Primary completion: 2023-12-20
• Completion: 2024-01-25
• First posted: 2021-01-22
• Last updated: 2022-05-09

Locations

1 site across 1 country: Italy