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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04718948
Other study ID # 17686_BIO
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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