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临床试验/NCT02149862
NCT02149862已完成不适用

FIRBladd - Use of Infrared Spectroscopy in the Diagnosis of Bladder Tumors

Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2014年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
137
试验地点
2
主要终点
infrared spectroscopy

研究概览

简要总结

The purpose of this study is too assess infrared spectroscopy ability to discriminate urine of a patient affected by bladder cancer from urine of reference patient.

详细描述

Bladder Cancer is the ninth cause of cancer worldwide, and it is still developing, due to growing risk factors such as Tobacco consumption. It has a high level of recurrence, which imposes regular screening and permanent treatment to the patient that has developed a bladder tumor.

Bladder cancer main symptom is blood in the urine, which has low specificity and sensibility. Other screening methods include cytology and image through cystoscopy. Conclusive diagnostic is performed by biopsy of the suspicious lesions. The latter methods are highly invasive.

Hence, it is necessary to develop non invasive technique for bladder cancer screening and follow up, as there is no reliable prognostic factor available. The investigators expect to improve the detection level in the urine by measuring and analyzing its absorption spectrum in the mid infrared, spectrum which provides a comprehensive image of metabolic situation.

Hence, the main objective of the study is to assess infrared spectroscopy ability to discriminate urine of a patient affected by bladder cancer from urine of reference patient. Success will be evaluated upon the discrimination level of cancer affected patient urine infrared spectrum vs. standard patient ones.

Secondary objective will be to assess the capability to detect different affection levels and tumors grade through the infrared spectrum analysis, as well as the predictive potential of the technique. The investigators may also assess the test intrinsic sensibility and specificity.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Patients with an indication of partial or total bladder resection
  • Lithiasic patients should be operated to a urinary calculation, without catheter "double J"
  • Free inform and written consent

排除标准

  • Patients also treated for other cancers
  • Lithiasic patients with catether "double J"
  • Pregnant or breast feeding women
  • Protected adults,

结局指标

主要结局

infrared spectroscopy

时间窗: the measure will be realized at the end of the studie, an expected average 18 month after the first inclusion

14 bands with a major local optimum value is retained on the spectrum. For each band, the positions and intensities of local optima are the set of explanatory variables. Discriminating threshold is estimated by validation Cross and chosen to have the best compromise between sensitivity and specificity.

次要结局

  • TNM system (tumor-nodes-metastasis)(the classification of the operating room will be carried out the day of the intervention or approximately 8 weeks after the inclusion)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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