Multimodal Spectroscopy to Detect Urothelial Cancer in Urine

NCT ID: NCT04718948

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2024-01-25

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.

Conditions

Urothelial Carcinoma; Urinary Bladder Cancer; Urinary Tract Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients Positive for Urinary Tract Cancer

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

Urinary Multimodal Fiber Optic Spectroscopy

Intervention Type: DEVICE

Approach based on a physical principle, mainly spectroscopy, which is rapid non-invasive and does not require the use of additional substances or contrast media in the diagnosis of urothelial neoplasms in urine samples.

It will be administered through a appositely designed device

Urine Cytology

Intervention Type: DIAGNOSTIC_TEST

An expert cytopathologist will analyze urine samples to detect urinary tract cancer cells. It is the current golden standard to detect urothelial cancer in urine

Surgery

Intervention Type: PROCEDURE

It will provide a reliable information on the presence/absence of cancer in the urinary tract (from direct visualization to pathological analysis)

Patients Negative for Urinary Tract Cancer

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

Urinary Multimodal Fiber Optic Spectroscopy

Intervention Type: DEVICE

Approach based on a physical principle, mainly spectroscopy, which is rapid non-invasive and does not require the use of additional substances or contrast media in the diagnosis of urothelial neoplasms in urine samples.

It will be administered through a appositely designed device

Urine Cytology

Intervention Type: DIAGNOSTIC_TEST

An expert cytopathologist will analyze urine samples to detect urinary tract cancer cells. It is the current golden standard to detect urothelial cancer in urine

Surgery

Intervention Type: PROCEDURE

It will provide a reliable information on the presence/absence of cancer in the urinary tract (from direct visualization to pathological analysis)

Interventions

Urinary Multimodal Fiber Optic Spectroscopy

Approach based on a physical principle, mainly spectroscopy, which is rapid non-invasive and does not require the use of additional substances or contrast media in the diagnosis of urothelial neoplasms in urine samples.

It will be administered through a appositely designed device

Intervention Type: DEVICE

Urine Cytology

An expert cytopathologist will analyze urine samples to detect urinary tract cancer cells. It is the current golden standard to detect urothelial cancer in urine

Intervention Type: DIAGNOSTIC_TEST

Surgery

It will provide a reliable information on the presence/absence of cancer in the urinary tract (from direct visualization to pathological analysis)

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

OTHER_GOV

Sponsor Role: collaborator

European Laboratory for Non-Linear Spectroscopy

UNKNOWN

Sponsor Role: collaborator

Careggi Hospital

OTHER

Sponsor Role: collaborator

University of Florence

OTHER

Sponsor Role: lead

Responsible Party

Simone Morselli

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mauro Gacci, MD

Role: PRINCIPAL_INVESTIGATOR

Careggi University Hospital

Enrico Baria, PhD

Role: PRINCIPAL_INVESTIGATOR

European Laboratory for Non-Linear Spectroscopy

Riccardo Cicchi, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Francesco Saverio Pavone, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Florence

Sergio Serni, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Florence

Gabriella Nesi, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Florence

Locations

Careggi Hospital

Florence, Tuscany, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Simone Morselli, MD

Role: CONTACT

simone.morselli.89@gmail.com

3473050852 ext. +39

Silvia Benemei, MD

Role: CONTACT

silvia.benemei@unifi.it

Facility Contacts

Simone Morselli

Role: primary

simone.morselli@unifi.it

3473050852

References

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.

Reference Type: BACKGROUND

PMID: 31343832 (View on PubMed)

Other Identifiers

17686_BIO

Identifier Type: -

Identifier Source: org_study_id