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RecruitingNCT02143986FERRITGLY01Updated Oct 6, 2025

Glycosylated Ferritin in Macrophagic Activation Syndromes

An observational study in Still's Disease, Adult-Onset, Sepsis and Macrophagic Activation Syndrome, sponsored by Brugmann University Hospital. Recruiting at 1 site in Belgium. Open to participants aged Up to 85 Years. Per ClinicalTrials.gov, last updated 2025-10-06.

Sponsored by Brugmann University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
Up to 85 Years
Sex
All
01

Study summary

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.

Read the detailed description

The objectives of this study are:

  1. . To evaluate the diagnostic performance of the assay of the glycosylated ferritin under HLH syndrome and Still's disease in adults.
  2. . To study the different glycoforms of ferritin from serum of patient with hyperferritinemia.

Materials and methods

  1. 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

  1. . Determination of the sensitivity and specificity of the diagnostic assay of the glycosylated ferritin under HLH syndrome and Still's disease .
  2. . 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.
  3. . Analysis of glycosylation patterns according to the patient subgroup.
02

Conditions studied

  • Still's Disease, Adult-Onset
  • Sepsis
  • Macrophagic Activation Syndrome

Keywords

  • sepsis
  • Macrophagic activation syndrome
  • Ferritin
  • Still's disease
03

In context

Still's Disease, Adult-Onset

23 studies on the registry are indexed under Still's Disease, Adult-Onset; 5 are open to participants now.

This study's planned enrollment of 60 is below the median of 155 across 10 observational studies indexed under Still's Disease, Adult-Onset.

Browse Still's Disease, Adult-Onset studies →

Lead sponsor

Brugmann University Hospital is the lead sponsor of 117 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All consecutive patients admitted in our hospital with inclusion criteria with a suspicion of sepsis or macrophagic activation syndrome.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Suspicion of sepsis, macrophagic activation syndrome, Still's disease or hyperferritinemia (malignant disease, hepatic cytolysis)

Exclusion criteria

Exclusion Criteria:

  • Normal ferritin level
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Macrophagic activation syndrome
  • Still's disease
  • Hyperferritinemia
  • Sepsis
06

What researchers measure

Primary outcomes

  1. Fraction of glycosylated ferritin in serum

    Time frame: One year

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02143986
Collaborators
Université Libre de Bruxelles
Responsible party
Francis Corazza (Head of laboratory of immunology, Brugmann University Hospital) — Principal investigator
First posted
May 21, 2014
Start date
May 2014
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Oct 6, 2025

Study contacts

Francis Corazza, MD, PhD
Contact
francis.corazza@ulb.ac.be
32-2-4772506
France Debaugnies, Pharm
Contact
france.debaugnies@chu-brugmann.be
32-2-4772507

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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