Multimodal Spectroscopy to Detect Urothelial Cancer in Urine

May 6, 2022 updated by: Simone Morselli, University of Florence

"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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Recruiting
        • Careggi Hospital
        • Sub-Investigator:
          • Alekseja Manera, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Device: 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

Diagnostic test: 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
Procedure: Surgery
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
Device: 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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Urine Multimodal Spectroscopy Grading
Time Frame: Enrollment
Evaluate whether multimodal spectroscopy is able to discriminate between high or low grade urothelial lesions on urine
Enrollment
Urine Multimodal Spectroscopy Site Discrimination
Time Frame: Enrollment
Evaluate whether multimodal spectroscopy is able to discriminate between lower or upper urinary tract lesions on urine
Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florence

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Careggi Hospital
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
European Laboratory for Non-Linear Spectroscopy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mauro Gacci, MD, Careggi University Hospital
  • Principal Investigator: Enrico Baria, PhD, European Laboratory for Non-Linear Spectroscopy
  • Principal Investigator: Riccardo Cicchi, PhD, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
  • Principal Investigator: Francesco Saverio Pavone, Prof, University of Florence
  • Principal Investigator: Gabriella Nesi, Prof, University of Florence

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17686_BIO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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