NCT05886309

Measurement of Serum Ferritin With a Cryo Detector Mass Spectrometer (CDMS)

Measurement of Serum Ferritin With a Cryo Detector Mass Spectrometer (CDMS): Pilot Study and First Experience in Testing Human Serum

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Serum Ferritin

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Collection of Blood samples	The following samples will be drawn from each study participant immediately after the venipuncture performed for the whole blood donation: * 1 sample with no anticoagulant (5 ml) for SF measurement with the CDMS method * 1 EDTA (Ethylendiamintetraazetat) sample (7,5 ml) for a complete blood count with red blood cell indices and reticulocytes * 1 EDTA sample (2,7 ml) for the measurement of hepcidin * 1 Li-Heparin-Gel sample (4.7 ml) for the measurement of SF with the ECLIA (Electrochemiluminescence-enzymeimmunoassay) and of the complete set of iron biomarkers (Transferrin Saturation, serum iron, Soluble Transferrin Receptor) * 1 Li-Heparin-Gel sample (4.7 ml) for the measurement of CRP (C-reactive Protein) * 1 sample with no anticoagulant (5 ml) for the measurement of SF with the CMIA (Chemiluminescence Immunoassay) * 1 sample with no anticoagulant (5 ml) for storage

Timeline

• Start date: 2024-02-12
• Primary completion: 2024-03-05
• Completion: 2024-05-05
• First posted: 2023-06-02
• Last updated: 2025-04-15

Locations

1 site across 1 country: Switzerland