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

NCT ID: NCT06087016

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-06

Study Completion Date

2026-03-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Urinary Bladder Tumour

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Urine vibrational analysis

Intervention Type OTHER

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.

Urine vibrational analysis

Intervention Type OTHER

Urine vibrational analysis

Interventions

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Urine vibrational analysis

Urine vibrational analysis

Intervention Type OTHER

Eligibility Criteria

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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

* Refused to participate in the study or unable to give consent
* without a native bladder
* with a bladder fistula
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Damien JOLLY

Reims, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Stéphane LARRE

Role: CONTACT

03 26 78 94 24 ext. 0033

Facility Contacts

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Stéphane LARRE

Role: primary

03 26 78 94 24 ext. 0033

Other Identifiers

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PO23014

Identifier Type: -

Identifier Source: org_study_id

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