ClinicalTrials.gov record NCT02143986
Glycosylated Ferritin in Macrophagic Activation Syndromes
Glycosylated Ferritin in Differential Diagnosis of Still's Disease, Sepsis and Other Macrophagic Activation Syndromes.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a prospective observational study that collects blood samples and clinical data to study glycosylated ferritin in people with suspected sepsis, macrophage activation syndrome (HLH), adult-onset Still's disease, or other causes of very high ferritin. The study measures the fraction of glycosylated ferritin and examines detailed ferritin glycoforms. Researchers will compare these measurements across patient groups to see how they relate to different diagnoses.
What it is studying. Whether the percentage of serum glycosylated ferritin and the patterns of ferritin glycoforms differ between adult-onset Still's disease, HLH/macrophage activation syndromes, sepsis, and other causes of hyperferritinemia—and whether those measures help distinguish these conditions.
What the researchers hope to learn. Determine the diagnostic performance (sensitivity and specificity) of glycosylated ferritin for HLH and adult Still's disease; characterize subgroups of patients by glycosylated ferritin fraction, ferritin glycoforms, and clinical/laboratory features.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
In healthy subjects, from 50 to 80 % of the serum ferritin is glycosylated [1, 2] . A decrease in the percentage of ferritin glycosylation can be observed in inflammatory diseases, malignancies, infections, or liver disease but is rarely less than 20% [3 , 4] . Percentage of glycosylated ferritin below 20% have been described in patients with adult Still's disease and haemophagocytosis lymphohistiocytic syndromes (HLH). The glycosylated ferritin has been included in the diagnostic criteria for Still's disease in adults. A cut-off of less than 20 % has a sensitivity and specificity of 72 and 69 % respectively , and 35 and 94 % when combined with a total ferritin level greater than 5 times normal value. This parameter was also suggested to be a more specific marker to confirm a diagnosis of HLH than a high ferritin level ( > 500μg / L). However, several limitations of this parameter were highlighted, some conditions making its interpretation difficult : particularly in cases of major hepatic cytolysis and severe sepsis (miliary tuberculosis, lymphoma and disease Adult Still). It is not always possible to distinguish severe sepsis, HLH syndrome and Still's disease. A fine analysis of various glycoforms components of ferritin could be used to distinguish different subgroups of patients. Few data are available on the mechanism of secretion and glycosylation of ferritin, but the investigators assume that the glycosylation patterns of ferritin may vary between different disease states and reflect distinct underlying pathophysiological mechanisms.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Suspicion of sepsis, macrophagic activation syndrome, Still's disease or hyperferritinemia (malignant disease, hepatic cytolysis)
Exclusion criteria
- Normal ferritin level
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
The objectives of this study are:
- . To evaluate the diagnostic performance of the assay of the glycosylated ferritin under HLH syndrome and Still's disease in adults.
- . To study the different glycoforms of ferritin from serum of patient with hyperferritinemia.
Materials and methods
- Patient groups studied and control group
- Any suspicion of HLH or Still's disease syndrome in adults
- Control groups: sepsis, severe sepsis, septic shock, inflammation ( lupus, rheumatoid arthritis), severe hepatic necrosis, hematologic malignancy at diagnosis or relapse
2 . Samples
- Serum will be collected for the determination of glycosylated ferritin in patients with suspicion of HLH syndrome or Still's disease in adults
- For the orther patients remaining serum samples will be collected from ferritin sample of the routine biological evaluation in patients with infammatory diseases ( lupus, rheumatoid arthritis) , hematologic malignancies at diagnosis or relapse, hepatic necrosis or sepsis.
3 . Characterization of patients based on diagnostic criteria (clinical and biological) retained (with collaborating physicians). After approval of the EC CHU Brugmann, the protocol will be submitted to other EC institutions. 4 . Analysis of the glycosylation profile of ferritin by mass spectrometry. (in collaboration with the Faculty of Pharmacy , Department of Pharmaceutical Chemistry , Van Antwerpen P and Delporte C) Analysis and interpretation
- . Determination of the sensitivity and specificity of the diagnostic assay of the glycosylated ferritin under HLH syndrome and Still's disease .
- . Characterization of subgroups of patients according to the following information: Ferritin and its glycosylated fraction, documented infections , fever, MOF , hepatomegaly, splenomegaly, haemophagocytosis (when bone marrow aspirate available), thrombocytosis, anemia, leukopenia, neutropenia, liver enzymes, hypertriglyceridemia, coagulopathy, hypofibrinogenemia, VS / CRP.
- . Analysis of glycosylation patterns according to the patient subgroup.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Give a blood sample (serum) for measurement of glycosylated ferritin; in some cases the study will use leftover serum from routine blood tests. Allow the study team to collect clinical information and routine laboratory results from your medical record; bone marrow aspirate findings will be used only if that procedure was already performed for clinical care. Serum samples will be analyzed for ferritin glycoforms (by mass spectrometry) and compared across patient groups.
How the study is structured. A prospective observational cohort study. Consecutive patients with suspected sepsis, macrophage activation syndrome, adult Still's disease, or other hyperferritinemia have serum collected and clinical data recorded. The laboratory analysis includes measuring the fraction of glycosylated ferritin (primary outcome over one year) and profiling ferritin glycoforms (by mass spectrometry). Researchers then compare results across patient groups.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Belgium. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on adult-onset Still's disease
Important dates
- Study start
- May 2014
- Primary completion
- December 2030 (estimated)
- Study completion
- December 2030 (estimated)
- Target enrollment
- 60 participants (estimated)
- Last updated on registry
- Oct 6, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Brugmann University Hospital
- Principal investigator
- Francis Corazza, Head of laboratory of immunology
Brugmann University Hospital - Collaborators
- Université Libre de Bruxelles
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Francis Corazza, MD, PhD 📞 32-2-4772506 ✉ francis.corazza@ulb.ac.be
- France Debaugnies, Pharm 📞 32-2-4772507 ✉ france.debaugnies@chu-brugmann.be
Participating sites (1)
- Brugmann University HospitalRecruiting
Brussels, 1020 · Belgium
- Francis Corazza, MD PhD · francis.corazza@ulb.ac.be
- France Debaugnies, Pharm · france.debaugnies@chu-brugmann.be
- francis Corazza, MD PhD
Terms used on this page · explanations by MedicalUpdates.ai
- healthy subjects
- People who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- control group
- The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
- relapse
- A condition that improved with treatment and has since returned or worsened.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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