Multimodal Spectroscopy to Detect Urothelial Cancer in Urine

Study Overview
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Brief Summary
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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.

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

Conditions
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Urothelial Carcinoma, Urinary Bladder Cancer, Urinary Tract Cancer

Intervention / Treatment
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* Device: Urinary Multimodal Fiber Optic Spectroscopy
* Diagnostic Test: Urine Cytology
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients Positive for Urinary Tract Cancer<br>Patients will undergo urinary cytology, multimodal spectroscopy in urine and urologic surgical intervention The group of cases will consist of patients who meet the inclusion and exclusion criteria in the operative note for: Transurethral Resection of Bladder Neoplasia (TURBT) Radical Cystectomy for Bladder Neoplasia Diagnostic ureterorenoscopy and / or laser treatment of ureteral and / or renal pelvis neoplasia Segmental ureterectomy with or without ureteral reimplantation Nephroureterectomy with or without bladder cuff excission | Device: Urinary Multimodal Fiber Optic Spectroscopy<br>* 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<br>Diagnostic Test: Urine Cytology<br>* 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<br>Procedure: Surgery<br>* It will provide a reliable information on the presence/absence of cancer in the urinary tract (from direct visualization to pathological analysis)<br>|
| Patients Negative for Urinary Tract Cancer<br>Patients will undergo urinary cytology, multimodal spectroscopy in urine and urologic surgical intervention The control group will consist of patients who meet the inclusion and exclusion criteria in the operative note for: Transurethral Resection of Prostate (TURP) Other endoscopic treatments of Benign Prostatic Hyperplasia (BPH) Open interventions of prostatic adenomectomy Endoscopic lithotripsy interventions of bladder stones or cystotomy with removal of bladder stones Rigid and / or flexible ureterorenoscopy for the treatment of kidney and / or ureteral stones Placement of ureteral catheter for ureteral and / or renal stones Bladder Neck Incision (TUIP) Endoscopic urethrotomy | Device: Urinary Multimodal Fiber Optic Spectroscopy<br>* 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<br>Diagnostic Test: Urine Cytology<br>* 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<br>Procedure: Surgery<br>* It will provide a reliable information on the presence/absence of cancer in the urinary tract (from direct visualization to pathological analysis)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Multimodal Spectroscopy Grading | Evaluate whether multimodal spectroscopy is able to discriminate between high or low grade urothelial lesions on urine | Enrollment | 
| Urine Multimodal Spectroscopy Site Discrimination | Evaluate whether multimodal spectroscopy is able to discriminate between lower or upper urinary tract lesions on urine | Enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Tract Cancer, Urine, Spectroscopy, Laser, Urine Cytology