Serum FerritinNCT05886309
Measurement of Serum Ferritin With a Cryo Detector Mass Spectrometer (CDMS)
An observational study of Serum Ferritin, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Serum Ferritin
- What is being tested?
- Collection of Blood samples
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Feb 2024to 5 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- acute illness
- chronic inflammatory disease
- Since pregnancy is a contraindication for blood donation, no pregnant women will be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Collection of Blood samples
- Keywords
- Cryo Detector Mass Spectrometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of Blood samplesDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the mass of serum ferritin molecules (kDa)
The primary outcome is the mass of SF molecules measured using the CDMS method
Measured: one time assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start12 Feb 2024
- Primary completion5 Mar 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serum FerritinStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Metromol SA
- Responsible party
- Sponsor
- Investigators
- Laura Infanti, PD Dr. med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886309
- Sponsor's protocol ID
- 2023-00550; th22Infanti
- Other IDs
- 2023
- Status last verified
- Apr 2025
- First submitted
- 23 May 2023
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Serum Ferritin With a Cryo Detector Mass Spectrometer (CDMS): Pilot Study and First Experience in Testing Human Serum
- ClinicalTrials.gov ID
- NCT05886309
- Acronym / sponsor ID
- 2023-00550; th22Infanti
- Conditions
- Serum Ferritin
- Keywords
- Cryo Detector Mass Spectrometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Metromol SA
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- acute illness
- chronic inflammatory disease
- Since pregnancy is a contraindication for blood donation, no pregnant women will be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of Blood samplesThe 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 | Diagnostic test | – |
Primary outcome
Assessment of the mass of serum ferritin molecules (kDa)
Time frame: one time assessment at baseline
The primary outcome is the mass of SF molecules measured using the CDMS method
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Infanti, PD Dr. med. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Serum Ferritin, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the mass of serum ferritin molecules (kDa) (time frame: one time assessment at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.