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

Completed

• Conditions: Serum Ferritin

• Registration Number: NCT05886309
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Study Timeline

• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-06-02
• Study Start: 2024-02-12
• Primary Completion: 2024-03-05
• Study Completion: 2024-05-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the mass of serum ferritin molecules (kDa)	one time assessment at baseline	The primary outcome is the mass of SF molecules measured using the CDMS method

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland