Clinical trial NCT06087016: Urinary Markers by SpectrosCopy: Diagnostic Aid in oncologY - Application to Urological Cancers
Official title: Urinary Markers by SpectrosCopy: Diagnostic Aid in oncologY - Application to Urological Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Bladder Tumour
Keywords: URINARY BLADDER NEOPLASMS
DIAGNOSIS
URINE
ANALYSIS
Spectroscopy
Fourier Transform Infrared
Raman
Spectrum Analysis
Multivariate Analysis
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending for cystoscopy examination or hospitalized in Urology department, Reims University Hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fourier Transform Infrared Spectroscopy
timeFrame: A 36 months
Secondary outcomes:
measure: Surface-enhanced Raman spectroscopy
timeFrame: A 36 months
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: