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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06087016
Acronym
MUSCADE
Enrollment
899
Registered
2023-10-17
Start date
2023-03-06
Completion date
2024-05-24
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder Tumour

Keywords

URINARY BLADDER NEOPLASMS, DIAGNOSIS, URINE, ANALYSIS, Spectroscopy, Fourier Transform Infrared, Raman, Spectrum Analysis, Multivariate Analysis

Brief summary

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

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.

Interventions

OTHERUrine vibrational analysis

Urine vibrational analysis

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fourier Transform Infrared SpectroscopyA 36 monthsAnalyze 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

MeasureTime frameDescription
Surface-enhanced Raman spectroscopyA 36 monthsAnalyze 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026