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临床试验/NCT02811952
NCT02811952已完成不适用

Measuring Urinary Nano Particles and Arsenic and Comparing Them to Cystoscopic Findings and Urinary Cytology in Patients Suspected With Urinary Bladder Malignancy

Carmel Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年6月23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
100
试验地点
1
主要终点
levels of nano particles and arsenic in urine

研究概览

简要总结

In many of urothelial carcinoma patients, one does not find common risk factors such as smoking. The medical center is located in an industrial city with known air and water pollution. The investigators decided to check the presence of nano particles and traces of metals in urinary samples of patients known and suspected for urothelial carcinoma and compare the results to both cystoscopic and cytological findings. The patients will fill a validated epidemiological respiratory disease survey and the results will be compared to a control group.

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

入选标准

  • Study group :
  • Patients that need cystoscopy due to suspicion/known bladder malignancy.
  • Patients that can read, understand and sign an informed consent form.
  • Control group:
  • Patients that need cystoscopy due to others reasons than malignancy.
  • Patients that present to the Department of Urology for surgery unrelated to malignancy of the urinary system ( prostatectomy, Incontinence repair, circumcision, hydrocele/ varicocele repair, ureteroscopy etc).

排除标准

  • Study group:
  • Patients receiving bladder irrigations, pregnant women, children and those with impaired judgment
  • Patients with a technically improper urine test.
  • Control group
  • Patients receiving bladder irrigations, pregnant women, children and those with impaired judgment
  • Patients with a technically improper urine test.

结局指标

主要结局

levels of nano particles and arsenic in urine

时间窗: one year

次要结局

未报告次要终点

研究者

发起方
Carmel Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilan Beniamin Klein

urologist

Carmel Medical Center

研究点 (1)

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