Multimodal Spectroscopy to Detect Urothelial Cancer in Urine

University of Florence (UNIFI)

Status: Unknown

Conditions: Urinary Bladder Cancer; Urinary Tract Cancer; Urothelial Carcinoma

Treatments: Device: Urinary Multimodal Fiber Optic Spectroscopy; Procedure: Surgery; Diagnostic Test: Urine Cytology

Study type: Observational

Funder types: Other

Identifiers

NCT04718948

17686_BIO

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

500 participants in 2 patient groups

Patients Positive for Urinary Tract Cancer

Description:

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

Treatment:

Device: Urinary Multimodal Fiber Optic Spectroscopy

Diagnostic Test: Urine Cytology

Procedure: Surgery

Patients Negative for Urinary Tract Cancer

Description:

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

Treatment:

Device: Urinary Multimodal Fiber Optic Spectroscopy

Diagnostic Test: Urine Cytology

Procedure: Surgery