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

NCT05886309 | Completed

• 1 other identifier: 2023-00550; th22Infanti
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Serum Ferritin

Keywords

Cryo Detector Mass Spectrometer

Outcome Measures

Primary Outcomes (1)

• Assessment of the mass of serum ferritin molecules (kDa)

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

  one time assessment at baseline

Interventions

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study cohort will include 20-25 experienced blood donors (not first-time donors) distributed among three groups according to SF values obtained from at least two previous measurements: * low SF levels: \< 20 ng/ml * normal SF levels: 50-200 ng/ml (women) or 50-300 ng/ml (men) * high SF levels: \> 200 ng/ml (women) or \> 300 ng/ml (men)

You may qualify if:

• 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

You may not qualify if:

• acute illness
• chronic inflammatory disease
• Since pregnancy is a contraindication for blood donation, no pregnant women will be included in the study.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Metromol SA: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

Study Officials

• Laura Infanti, PD Dr. med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: February 12, 2024
• Primary Completion: March 5, 2024
• Study Completion: May 5, 2024
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

CH (1)