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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Serum Ferritin
• Intervention / Treatment: Diagnostic test: Collection of Blood samples

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 Type: Observational
• Enrollment (Estimated): 22

Contacts and Locations

• Study Contact: Name: Laura Infanti, PD Dr. med.; Phone Number: +41 61 328 60 83; Email: laura.infanti@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel
    • Contact: Laura Infanti, PD Dr. med.; Phone Number: +41 61 328 60 83; Email: laura.infanti@usb.ch
    • Principal Investigator: Laura Infanti, PD Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Metromol SA
• Investigators: Principal Investigator: Laura Infanti, PD Dr. med., University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Actual): March 5, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cryo Detector Mass Spectrometer
• Other Study ID Numbers: 2023-00550; th22Infanti

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No