Urinary Markers by SpectrosCopy: Diagnostic Aid in oncologY - Application to Urological Cancers

Study Overview
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Brief Summary
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This study aims to evaluate the performance of vibrational spectroscopy (Infrared and Raman spectroscopy techniques) in bladder cancer diagnosis using urine samples.

Detailed Description
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Urologic cancers affect the organs and structures of the male and female urinary tract and the male reproductive system. Bladder cancer (BCa) is the second urological cancer in incidence after prostate cancer and represents the 10th most common cancer in the world. This cancer has high recurrence and progression rates. Cystoscopy and urine cytology are the current gold-standard examination for bladder cancer. Nevertheless, the first is invasive and the latter has low sensitivity especially for low-grade bladder cancer. Therefore, it is critical to implement accurate, non- invasive and sensitive examination tool to diagnose patients with bladder cancer at an early stage. On the one hand, urine is collected non-invasively and considered as a proximal biofluid from bladder. On the other hand, vibrational spectroscopy including Infrared and Raman spectroscopy is widely used for the analysis of biological samples and provides a molecular fingerprint of the sample with minimum or no sample preparation. Applied on urine, this technique may offer interesting alternative for bladder cancer diagnosis and monitoring. Hence, this research project aims to evaluate the analytical capabilities of urinary vibrational spectroscopy with the objective of developing a diagnostic test for urothelial bladder cancer. The study is planned for 36 months. Patients that approve their participation in the study will respond to a questionnaire allowing us to have clinical information. From these patients, urine samples will be collected in Urology department of Reims University Hospital. Urine samples will be directly analyzed by Fourier Transform Infrared Spectroscopy and/or Surface-enhanced Raman spectroscopy then stored at -80°C for further analysis.

Official Title
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Urinary Markers by SpectrosCopy: Diagnostic Aid in oncologY - Application to Urological Cancer

Conditions
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Urinary Bladder Tumour

Intervention / Treatment
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* Other: Urine vibrational analysis


Participation Criteria
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Eligibility Criteria
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inclusion criteria: Must be over 18 years of age Able to give consent and understand the purpose the study Agree to participate in the study and having signed the non-objection document Admitted to a urology consultation for cystoscopy exclusion criteria: Patients with any of the following criteria will not be included in the study Refused to participate in the study or unable to give consent without a native bladder with a bladder fistula

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bladder cancer group<br>Bladder cancer group represents patients attending or hospitalized in Urology department, Reims University Hospital and in whom, tumor is visualized during cystoscopy and confirmed by the histological examination of entire resected lesion after Trans Urethral Resection of Bladder Tumor (TURBT). | Other: Urine vibrational analysis<br>* Urine vibrational analysis<br>|
| Control group<br>Control group includes patients consulting for cystoscopy examination in Urology department, Reims University Hospital without any tumor visualization during cystoscopy examination. | Other: Urine vibrational analysis<br>* Urine vibrational analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fourier Transform Infrared Spectroscopy | Analyze urine samples by infrared spectroscopy after drying step and without any further sample preparation. The obtained spectra will be preprocessed and analyzed by multivariate algorithms to discriminate bladder cancer patients from control group. | A 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surface-enhanced Raman spectroscopy | Analyze urine samples by Surface-enhanced Raman spectroscopy after mixing urine samples with silver nanoparticles. The obtained spectra will be preprocessed and analyzed by multivariate algorithms to discriminate bladder cancer patients from control group. | A 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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URINARY BLADDER NEOPLASMS, DIAGNOSIS, URINE, ANALYSIS, Spectroscopy, Fourier Transform Infrared, Raman, Spectrum Analysis, Multivariate Analysis