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临床试验/NCT04393376
NCT04393376Unknown不适用

Evaluation of Prostate-Specific Antigen Glycomics Assay for the Early Detection of Prostate Cancer

Prof.dr. H.P. Beerlage3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
3
主要终点
PSA Glycomics Assay

研究概览

简要总结

The principal aim of this pilot study is to test whether the PSA Glycomics Assay on urine and serum samples can provide insights regarding the disease state of patients with elevated PSA concentrations, as well as to accurately identify if the patient has prostate cancer and, in the case of prostate cancer, to determine its level of aggressiveness.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •Patients with elevated PSA (>3 ng/mL)
  • •Signed informed consent

排除标准

  • •Patients that have a cystitis (bladder infection)
  • •Patients under chemotherapy
  • •Patients using 5-alpha reductase inhibitors
  • •History or presence of cancers, or non-prostate urological disorders.

结局指标

主要结局

PSA Glycomics Assay

时间窗: 1 year

The relative abundance of glycoforms of PSA in plasma and urine from the subjects will be measured. These will be related to the stage of PCa and compared to non-prostate cancer patients.

次要结局

未报告次要终点

研究者

发起方
Prof.dr. H.P. Beerlage
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof.dr. H.P. Beerlage

Urologist, Head of Department of Urology

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (3)

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