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
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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