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

Sponsor

CHU de Reims (Other)

Overall Status

Recruiting

CT.gov ID

NCT06087016

Collaborator

(none)

1,800

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder Tumour	Other: Urine vibrational analysis

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1800 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 6, 2023

Anticipated Primary Completion Date :

Mar 6, 2025

Anticipated Study Completion Date :

Mar 6, 2026

Arms and Interventions

Arm	Intervention/Treatment
Bladder cancer group 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 Urine vibrational analysis
Control group 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 Urine vibrational analysis

Arm

Intervention/Treatment

Bladder cancer group

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

Urine vibrational analysis

Control group

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

Urine vibrational analysis

Outcome Measures

Primary Outcome Measures

Fourier Transform Infrared Spectroscopy [A 36 months]
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.

Secondary Outcome Measures

Surface-enhanced Raman spectroscopy [A 36 months]
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.