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临床试验/NCT01915316
NCT01915316已完成不适用

Measurements Of Zinc Concentration On Specimens Taken During Trans-Perineal Prostate Biopsy

ProSight1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Verify the existence of correlation between low levels of Zinc concentration in a biopsy specimen and the prostate cancer grade for that specimen determined by pathology.

研究概览

简要总结

The purposes of this study are to: i) confirm and improve the accuracy of the correlation between levels of Zinc in prostate tissue and the grade of prostate cancer in that tissue as determined through pathology; and ii) determine the levels of zinc in prostate tissue declared as non-cancerous by pathology and located in the vicinity of tissue declared as cancerous by pathology, and verify that the Zinc levels for the declared non-cancerous tissue are lower (statistically significantly) than the levels for benign tissue not in the vicinity of cancerous tissue.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Elevated PSA, >10ng/mL
  • Subject underwent primary and at least one secondary (repeat) prostate biopsy with negative diagnosis
  • Subject directed at saturated trans-perineal biopsy

排除标准

  • Subject was under Zn supplement nutrition treatment

结局指标

主要结局

Verify the existence of correlation between low levels of Zinc concentration in a biopsy specimen and the prostate cancer grade for that specimen determined by pathology.

时间窗: Zinc measurements on biopsy specimens are performed during the biopsy session; pathology classification is typically performed within 2-4 weeks.

次要结局

  • Verify that the levels of zinc in non-cancerous specimens located in the vicinity of a specimen declared as cancerous by pathology are lower (statistically significantly) than the levels for benign specimens not in the vicinity of the cancerous specimen.(Time frame for pathology: within 2-4 weeks)

研究者

发起方
ProSight
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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