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

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

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

Study Overview

• Status: Recruiting
• Conditions: Urinary Bladder Tumour
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 1800

Contacts and Locations

• Study Contact: Name: Stéphane LARRE; Phone Number: 0033 03 26 78 94 24; Email: slarre@chu-reims.fr

Study Locations

• France
  • Reims, France
    • Recruiting
    • Damien JOLLY
    • Contact: Stéphane LARRE; Phone Number: 0033 03 26 78 94 24; Email: slarre@chu-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients attending for cystoscopy examination or hospitalized in Urology department, Reims University Hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Estimated): March 6, 2025
• Study Completion (Estimated): March 6, 2026

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Spectroscopy; Spectrum Analysis; Raman; Multivariate Analysis; DIAGNOSIS; URINARY BLADDER NEOPLASMS; URINE; ANALYSIS; Fourier Transform Infrared
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Urologic Neoplasms
• Other Study ID Numbers: PO23014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No