Measurement of Serum Ferritin With a Cryo Detector Mass Spectrometer (CDMS): Pilot Study and First Experience in Testing Human Serum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Assessment of the mass of serum ferritin molecules (kDa)
研究概览
简要总结
The study will explore the performance of the CDMS (Cryo Detector Mass Spectrometer) method in measuring SF (serum ferritin) in human serum of healthy individuals. This will be the first experience of testing SF with this method using biologic material of human origin.
详细描述
A clear interpretation of hyperferritinemia is difficult in many clinical situations. Crucial for the correct treatment of patients is the differentiation between reactively elevated ferritin and effective iron overload.The measurement methods that are routinely used provide quantitative results of the measurement of total ferritin molecules independent of their actual iron content.With a modified mass spectrometric method (CDMS), this should be possible.
In this study the investigators would like to apply this measurement technique for the first time with human serum as the investigators would like to test healthy blood donors with known normal, low or elevated ferritin levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-75 years
- •SF (serum ferritin) values known from a previous determination that must not be older than twelve months and not followed by a blood donation
- •fulfillment of the eligibility criteria for blood donation
- •negative serology for HBV (hepatitis B virus), HCV (hepatitis C virus), HIV (human immunodeficiency virus) as assessed in the context of a blood donation
排除标准
- •acute illness
- •chronic inflammatory disease
- •Since pregnancy is a contraindication for blood donation, no pregnant women will be included in the study.
结局指标
主要结局
Assessment of the mass of serum ferritin molecules (kDa)
时间窗: one time assessment at baseline
The primary outcome is the mass of SF molecules measured using the CDMS method
次要结局
未报告次要终点