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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05886309
Other study ID # 2023-00550; th22Infanti
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 12, 2024
Est. completion date June 2024

Study information

Verified date March 2024
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 22
Est. completion date June 2024
Est. primary completion date March 5, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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

Locations

Country Name City State
Switzerland University Hospital Basel Basel

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland Metromol SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01996683 - Efficacy and Safety of Efficacy and Safety of Continued Iron Chelation Therapy In Poly-transfused Thalassemia Patients With Low Serum Ferritin (< 500 ng/ml) N/A
Recruiting NCT06232642 - Effects of Lactoferrin-enriched Whey on Iron Status in Females N/A