Skip to main content
OpenTrials
Completed

NCT Number: NCT05886309

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Serum Ferritin

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • acute illness
  • chronic inflammatory disease

Since pregnancy is a contraindication for blood donation, no pregnant women will be included in the study.

Treatment and study plan

Collection of Blood samples

Diagnostic Test

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

Primary outcomes

  1. Assessment of the mass of serum ferritin molecules (kDa)

    Time frame: one time assessment at baseline

    The primary outcome is the mass of SF molecules measured using the CDMS method

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Metromol SA

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2023
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.