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

NCT ID: NCT05886309

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2024-05-05

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.

Conditions

Serum Ferritin

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Metromol SA

UNKNOWN

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Infanti, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2023-00550; th22Infanti

Identifier Type: -

Identifier Source: org_study_id