Multimodal Spectroscopy to Detect Urothelial Cancer in Urine

• Conditions: Urinary Bladder Cancer; Urothelial Carcinoma; Urinary Tract Cancer
• Interventions: Device: Urinary Multimodal Fiber Optic Spectroscopy; Diagnostic Test: Urine Cytology; Procedure: Surgery

• Registration Number: NCT04718948
• Lead Sponsor: University of Florence

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-18
• Study First Posted: 2021-01-22
• Study Start: 2021-01-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-09
• Primary Completion: 2023-12-20
• Study Completion: 2024-01-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients Positive for Urinary Tract Cancer	Urinary Multimodal Fiber Optic Spectroscopy	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
Patients Positive for Urinary Tract Cancer	Urine Cytology	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
Patients Negative for Urinary Tract Cancer	Urine Cytology	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
Patients Negative for Urinary Tract Cancer	Surgery	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
Patients Positive for Urinary Tract Cancer	Surgery	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
Patients Negative for Urinary Tract Cancer	Urinary Multimodal Fiber Optic Spectroscopy	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Careggi Hospital; 🇮🇹 Florence, Tuscany, Italy