Determination of Prostate-specific Antigen in Capillary Blood (PSA-Cap)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Accuracy of PSA measurement in capillary blood vs. venous blood
研究概览
简要总结
The aim of the PSA-Cap study is to test the comparability of measurements of total PSA in serum from venipuncture and in serum from capillary blood using anonymized diagnostic blood samples from patients. Furthermore, a stability test of the samples is carried out after storage at room temperature for 24, 72/96 and 168 hours. Particular attention is paid to the comparability of the measurement results and the influence of the transportation time.
详细描述
Interventions that are conducted with the PSA-Cap trial are the collection of capillary blood (6 droplets) from the fingertip during regular PSA testing in venous blood. PSA is measured in the serum fraction of both samples (capillary and venous) using the established routine procedure, either immediately or after simulation of common transport conditions (intermediate storage for 24; 72/96 h and 168 h at 22 °C). Control measurements include parameters of cell lysis (LDH, HIL check) and general protein stability (albumin). The patient samples used are anonymized at the source by means of a consecutive series of numbers. The anonymized result groups are compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged from 45 to 70 years
- •Informed consent for PSA measurement for prostate cancer screening
排除标准
- •Patients unable to give consent
结局指标
主要结局
Accuracy of PSA measurement in capillary blood vs. venous blood
时间窗: After 0 h, 1 d, 3/4 d and 7 d
次要结局
- PSA stability in serum fraction of both samples (capillary and venous)(After 0 h, 1 d, 3/4 d and 7 d)
研究者
Dr. med. Rouvier Al-Monajjed
Oberarzt
Heinrich-Heine University, Duesseldorf