Urothelial CarcinomaNCT04718948
Multimodal Spectroscopy to Detect Urothelial Cancer in Urine
An observational study of Urothelial Carcinoma and Urinary Bladder Cancer, run by University of Florence at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma, Urinary Bladder Cancer, Urinary Tract Cancer
- What is being tested?
- Urinary Multimodal Fiber Optic Spectroscopy, Urine Cytology and Surgery
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jan 2021to 25 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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 locations and contacts
1 site in 1 country.
Silvia Benemei, MD contact
Italy1 site, 1 recruiting
- Recruiting
Careggi Hospital
Florence, Tuscany, 50134
Simone Morselli, 3473050852, simone.morselli@unifi.it
Alekseja Manera, MD
About this study
Official title: "The Feasibility of a Multimodal Spectroscopy Analysis to Detect Urothelial Cancer in Urine"
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.
Read more
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.
- Being tested
- Urinary Multimodal Fiber Optic Spectroscopy, Urine Cytology, Surgery
- Keywords
- Urinary Tract Cancer, Urine, Spectroscopy, Laser, Urine Cytology
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary Multimodal Fiber Optic SpectroscopyDevice
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 CytologyDiagnostic 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
SurgeryProcedure or surgery
It will provide a reliable information on the presence/absence of cancer in the urinary tract (from direct visualization to pathological analysis)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Urinary Multimodal Fiber Optic Spectroscopy; Diagnostic Test: Urine Cytology; Procedure: Surgery | |
| 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 Receives: Device: Urinary Multimodal Fiber Optic Spectroscopy; Diagnostic Test: Urine Cytology; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Multimodal Spectroscopy Reliability
Evaluate whether multimodal spectroscopy can discriminate between healthy controls and patients with urothelial neoplasia on urine, with an accuracy at least comparable to urinary cytology on 3 samples
Measured: Enrollment
Secondary outcomes (2)
Urine Multimodal Spectroscopy Grading
Evaluate whether multimodal spectroscopy is able to discriminate between high or low grade urothelial lesions on urine
Measured: Enrollment
Urine Multimodal Spectroscopy Site Discrimination
Evaluate whether multimodal spectroscopy is able to discriminate between lower or upper urinary tract lesions on urine
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start28 Jan 2021
- Primary completion20 Dec 2023 (estimated)
- Study completion25 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, European Laboratory for Non-Linear Spectroscopy, Careggi Hospital
- Responsible party
- Principal investigator, Simone Morselli, University of Florence
- Investigators
- Mauro Gacci, MD, Principal investigator, Careggi University HospitalEnrico Baria, PhD, Principal investigator, European Laboratory for Non-Linear SpectroscopyRiccardo Cicchi, PhD, Principal investigator, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, ItalyFrancesco Saverio Pavone, Prof, Principal investigator, University of FlorenceSergio Serni, Prof, Principal investigator, University of FlorenceGabriella Nesi, Prof, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718948
- Sponsor's protocol ID
- 17686_BIO
- Status last verified
- May 2022
- First submitted
- 18 Jan 2021
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31343832
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Feasibility of a Multimodal Spectroscopy Analysis to Detect Urothelial Cancer in Urine"
- ClinicalTrials.gov ID
- NCT04718948
- Acronym / sponsor ID
- 17686_BIO
- Keywords
- Urinary Tract Cancer, Urine, Spectroscopy, Laser, Urine Cytology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, European Laboratory for Non-Linear Spectroscopy, Careggi Hospital
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 25 Jan 2024 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Positive for Urinary Tract Cancer | – | Device: Urinary Multimodal Fiber Optic Spectroscopy, Diagnostic Test: Urine Cytology, Procedure: SurgeryPatients 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 |
| Patients Negative for Urinary Tract Cancer | – | Device: Urinary Multimodal Fiber Optic Spectroscopy, Diagnostic Test: Urine Cytology, Procedure: SurgeryPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary Multimodal Fiber Optic SpectroscopyApproach 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 | Device | Patients Negative for Urinary Tract Cancer, Patients Positive for Urinary Tract Cancer |
| Urine CytologyAn expert cytopathologist will analyze urine samples to detect urinary tract cancer cells. It is the current golden standard to detect urothelial cancer in urine | Diagnostic test | Patients Negative for Urinary Tract Cancer, Patients Positive for Urinary Tract Cancer |
| SurgeryIt will provide a reliable information on the presence/absence of cancer in the urinary tract (from direct visualization to pathological analysis) | Procedure or surgery | Patients Negative for Urinary Tract Cancer, Patients Positive for Urinary Tract Cancer |
Primary outcome
Urine Multimodal Spectroscopy Reliability
Time frame: Enrollment
Evaluate whether multimodal spectroscopy can discriminate between healthy controls and patients with urothelial neoplasia on urine, with an accuracy at least comparable to urinary cytology on 3 samples
2 secondary outcomes
Urine Multimodal Spectroscopy Grading
Time frame: Enrollment
Urine Multimodal Spectroscopy Site Discrimination
Time frame: Enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Background: PubMed 31343832Baria 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.
- Individual participant dataSharing planned: No
Related trials for Urothelial Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Registry Platform Urologic Cancer
Renal Cell Carcinoma, Urothelial Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Benemei, MD contact
Mauro Gacci, MD principal investigator
Careggi University Hospital
Enrico Baria, PhD principal investigator
European Laboratory for Non-Linear Spectroscopy
Riccardo Cicchi, PhD principal investigator
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma and Urinary Bladder Cancer, run by University of Florence at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simone Morselli, MD (3473050852 ext. +39, simone.morselli.89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Multimodal Spectroscopy Reliability (time frame: Enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04718948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.