Brief Title
Multimodal Spectroscopy to Detect Urothelial Cancer in Urine
Official Title
"The Feasibility of a Multimodal Spectroscopy Analysis to Detect Urothelial Cancer in Urine"
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.
Study Type
Observational
Primary Outcome
Urine Multimodal Spectroscopy Reliability
Secondary Outcome
Urine Multimodal Spectroscopy Grading
Condition
Urothelial Carcinoma
Intervention
Urinary Multimodal Fiber Optic Spectroscopy
Study Arms / Comparison 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
500
Start Date
January 28, 2021
Completion Date
January 25, 2024
Primary Completion Date
December 20, 2023
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mauro Gacci, MD, 3473050852, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT04718948
Organization ID
17686_BIO
Responsible Party
Principal Investigator
Study Sponsor
University of Florence
Collaborators
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Study Sponsor
Mauro Gacci, MD, Principal Investigator, Careggi University Hospital
Verification Date
May 2022