Urinary Bladder Cancer, Urinary Tract Cancer, Urothelial Carcinoma
Conditions
Keywords
Urinary Tract Cancer, Urine, Spectroscopy, Laser, Urine Cytology
Brief 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.
Interventions
DEVICEUrinary 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_TESTUrine 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
PROCEDURESurgery
It will provide a reliable information on the presence/absence of cancer in the urinary tract (from direct visualization to pathological analysis)
Sponsors
Fondazione C.N.R./Regione Toscana G. Monasterio, Pisa, Italy
European Laboratory for Non-Linear Spectroscopy
Careggi Hospital
University of Florence
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine Multimodal Spectroscopy Reliability | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine Multimodal Spectroscopy Grading | Enrollment | Evaluate whether multimodal spectroscopy is able to discriminate between high or low grade urothelial lesions on urine |
| Urine Multimodal Spectroscopy Site Discrimination | Enrollment | Evaluate whether multimodal spectroscopy is able to discriminate between lower or upper urinary tract lesions on urine |
Countries
Italy
Contacts
Primary ContactSimone Morselli, MD
Backup ContactSilvia Benemei, MD
Outcome results
None listed