Clinical trial · Observational
Multimodal Spectroscopy to Detect Urothelial Cancer in Urine
"The Feasibility of a Multimodal Spectroscopy Analysis to Detect Urothelial Cancer in Urine"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urinary Bladder Cancer | Malignant Bladder Neoplasm | ALIAS | 0.90 |
| Urinary Tract Cancer | Malignant Urinary Tract Neoplasm | ALIAS | 0.90 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery | Procedure | — | UNRESOLVED |
| Urinary Multimodal Fiber Optic Spectroscopy | Device | — | UNRESOLVED |
| Urine Cytology | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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
- interventionNames
- Device: Urinary Multimodal Fiber Optic Spectroscopy
- Diagnostic Test: Urine Cytology
- Procedure: Surgery
- label
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDBaria 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. PMID 31343832