Multimodal Spectroscopy to Detect Urothelial Cancer in Urine

Urothelial Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04718948
• Other study ID #: 17686_BIO
• Status: Recruiting
• Start date: January 28, 2021
• Est. completion date: January 25, 2024

Study information

• Verified date: May 2022
• Source: University of Florence
• Contact: Simone Morselli, MD
• Phone: 3473050852
• Email: simone.morselli.89[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 25, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

CASES Inclusion criteria Patients over the age of 18 who are known for urological interventions for the following

pathologies will be considered for enrollment in the group of cases:

• Bladder cancer
• Urethral tumor
• Renal Pelvis Tumor
• Ureteral tumor

The exclusion criteria will be:

• Age under 18
• Pregnancy
• Lack of informed consent
• Persons with indwelling catheter
• Presence of prostate cancer
• Presence and / or history of renal cancer, except tumors of the renal pelvis CHECKS Inclusion criteria Patients over the age of 18 who are known for urological interventions for the following

pathologies will be considered for enrollment in the control group:

• Kidney, ureteral or bladder stones
• BPH

The exclusion criteria will be:

• Age under 18
• Pregnancy
• Lack of informed consent
• Indwelling Catheter wearers
• Presence of prostate cancer
• Presence of kidney cancer, including kidney pelvic tumors
• Presence and / or history of ureteral cancer
• Presence and / or history of bladder cancer
• Presence and / or history of urethral cancer

Related Conditions & MeSH terms

• Urinary Bladder Cancer
• Urinary Bladder Neoplasms
• Urinary Tract Cancer
• Urologic Neoplasms
• Urothelial Carcinoma

Intervention

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)

Locations

Country	Name	City	State
Italy	Careggi Hospital	Florence	Tuscany

Sponsors (4)

Lead Sponsor	Collaborator
University of Florence	Careggi Hospital, European Laboratory for Non-Linear Spectroscopy, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Baria E, Morselli S, Anand S, Fantechi R, Nesi G, Gacci M, Carini M, Serni S, Cicchi R, Pavone FS. Label-free grading and staging of urothelial carcinoma through multimodal fibre-probe spectroscopy. J Biophotonics. 2019 Nov;12(11):e201900087. doi: 10.1002/jbio.201900087. Epub 2019 Aug 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine Multimodal Spectroscopy Reliability	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	Enrollment
Secondary	Urine Multimodal Spectroscopy Grading	Evaluate whether multimodal spectroscopy is able to discriminate between high or low grade urothelial lesions on urine	Enrollment
Secondary	Urine Multimodal Spectroscopy Site Discrimination	Evaluate whether multimodal spectroscopy is able to discriminate between lower or upper urinary tract lesions on urine	Enrollment