NCT02143986

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
56mo left

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
May 2014Dec 2030

Study Start

First participant enrolled

May 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
16.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

October 6, 2025

Status Verified

October 1, 2025

Enrollment Period

16.6 years

First QC Date

May 19, 2014

Last Update Submit

October 1, 2025

Conditions

Keywords

sepsisMacrophagic activation syndromeFerritinStill's disease

Outcome Measures

Primary Outcomes (1)

  • Fraction of glycosylated ferritin in serum

    One year

Study Arms (4)

Macrophagic activation syndrome

Still's disease

Hyperferritinemia

Sepsis

Eligibility Criteria

AgeUp to 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Normal ferritin level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brugmann University Hospital

Brussels, 1020, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Still's Disease, Adult-OnsetSepsisArthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Francis Corazza, MD, PhD

CONTACT

France Debaugnies, Pharm

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of laboratory of immunology

Study Record Dates

First Submitted

May 19, 2014

First Posted

May 21, 2014

Study Start

May 1, 2014

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

October 6, 2025

Record last verified: 2025-10

Locations