Clinical trial NCT04718948: Multimodal Spectroscopy to Detect Urothelial Cancer in Urine
Official title: "The Feasibility of a Multimodal Spectroscopy Analysis to Detect Urothelial Cancer in Urine"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urothelial Carcinoma
Urinary Bladder Cancer
Urinary Tract Cancer
Keywords: Urinary Tract Cancer
Urine
Spectroscopy
Laser
Urine Cytology
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
name: European Laboratory for Non-Linear Spectroscopy
name: Careggi Hospital
First posted: 2021-01-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who meet the inclusion and exclusion criteria will be enrolled at Urology ward admission. Informed consent will be collected. Patients therapeutic routine will be unaffected.

In the morning before surgery, the patient will collect urine sample. The patient will then continue the previously established diagnostic therapeutic process. The sample will be brought to the spectroscopic and cytological analysis. Samples will not be stored.

According to the sample size calculation based on the asymptotic normal distribution theory, a total of 240 cases and 240 controls will be required if the study is to have 90% power. A series of 5000 simulations generating binary test data with a true positive frequency and a true negative frequency of 80% showed that these sample sizes produce 89% power. Increasing the sample size to 250 cases and 250 controls increases the potency to 90%. Therefore, approximately 250 cases and 250 controls will be enrolled in this phase 2 validation study.

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.


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

Primary outcomes:
measure: Urine Multimodal Spectroscopy Reliability
timeFrame: Enrollment
Secondary outcomes:
measure: Urine Multimodal Spectroscopy Grading
timeFrame: Enrollment
measure: Urine Multimodal Spectroscopy Site Discrimination
timeFrame: Enrollment
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Careggi Hospital
state: Tuscany
Study officials:
affiliation: Careggi University Hospital
name: Mauro Gacci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: European Laboratory for Non-Linear Spectroscopy
name: Enrico Baria, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
name: Riccardo Cicchi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florence
name: Francesco Saverio Pavone, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florence
name: Sergio Serni, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florence
name: Gabriella Nesi, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baria 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.