NCT04130776已完成不适用
Demonstrating the Stability of the Analytes Measured for 4Kscore: Total PSA (tPSA), Free PSA (fPSA), Intact PSA (iPSA), and Human Kallikrein 2 (hk2) in Clinical Serum Samples Stored Uncentrifuged Before Testing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- fPSA changes in 3 days
研究概览
简要总结
The purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men capable of donating five 5 mL tubes of whole blood
- •40 to 80 years old
- •No prior diagnosis of prostate cancer; prior negative prostate biopsy included
- •Total PSA (tPSA) value measured within last year to be: at 1.5 ng/mL to 4 ng/mL, 4.1 ng/mL to 10 ng/mL and 10 ng/mL and above
排除标准
- •In the previous 96 hours (4 days), underwent a digital rectal exam
- •Any invasive urologic procedure in the 6 months prior to study participation
- •Underwent any procedure to treat symptomatic benign prostatic hyperplasia in the last 6 months
- •Radical prostatectomy since tPSA measurement
- •Received within the previous 6 months 5-alpha reductase inhibitor (5-ARI) therapy such as Avodart (dutasteride) or Proscar (finasteride)
结局指标
主要结局
fPSA changes in 3 days
时间窗: Day 0, 1, 2 and 3
Measure fPSA in serum samples at day 0, 1, 2 and 3
hK2 changes in 3 days
时间窗: Day 0, 1, 2 and 3
Measure hK2 in serum samples at day 0, 1, 2 and 3
tPSA changes in 3 days
时间窗: Day 0, 1, 2 and 3
Measure tPSA in serum samples at day 0, 1, 2 and 3
iPSA changes in 3 days
时间窗: Day 0, 1, 2 and 3
Measure iPSA in serum samples at day 0, 1, 2 and 3
次要结局
未报告次要终点
研究者
研究点 (1)
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