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NCT Number: NCT06087016

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urine vibrational analysis

Other

Urine vibrational analysis

Primary outcomes

  1. Fourier Transform Infrared Spectroscopy

    Time frame: 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 outcomes

  1. Surface-enhanced Raman spectroscopy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

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

Acronym: MUSCADE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2023
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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