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临床试验/NCT06087016
NCT06087016已完成不适用

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

CHU de Reims1 个研究点 分布在 1 个国家目标入组 899 人开始时间: 2023年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
899
试验地点
1
主要终点
Fourier Transform Infrared Spectroscopy

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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).

干预措施: Urine vibrational analysis (Other)

Control group

Control group includes patients consulting for cystoscopy examination in Urology department, Reims University Hospital without any tumor visualization during cystoscopy examination.

干预措施: Urine vibrational analysis (Other)

结局指标

主要结局

Fourier Transform Infrared Spectroscopy

时间窗: 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.

次要结局

  • Surface-enhanced Raman spectroscopy(A 36 months)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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