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Glycosylated Ferritin in Macrophagic Activation Syndromes (FERRITGLY01)

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ClinicalTrials.gov Identifier: NCT02143986
Recruitment Status : Recruiting
First Posted : May 21, 2014
Last Update Posted : January 19, 2018
Sponsor:
Collaborator:
Université Libre de Bruxelles
Information provided by (Responsible Party):
Francis Corazza, Brugmann University Hospital

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.


Condition or disease
Still's Disease, Adult-Onset Sepsis Macrophagic Activation Syndrome

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.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Glycosylated Ferritin in Differential Diagnosis of Still's Disease, Sepsis and Other Macrophagic Activation Syndromes.
Study Start Date : May 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort
Macrophagic activation syndrome
Still's disease
Hyperferritinemia
Sepsis



Primary Outcome Measures :
  1. Fraction of glycosylated ferritin in serum [ Time Frame: One year ]

Biospecimen Retention:   Samples Without DNA
Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Normal ferritin level

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143986


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

Locations
Belgium
Brugmann University Hospital Recruiting
Brussels, Belgium, 1020
Contact: Francis Corazza, MD PhD       francis.corazza@ulb.ac.be   
Contact: France Debaugnies, Pharm       france.debaugnies@chu-brugmann.be   
Principal Investigator: francis Corazza, MD PhD         
Sponsors and Collaborators
Brugmann University Hospital
Université Libre de Bruxelles

Responsible Party: Francis Corazza, Head of laboratory of immunology, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02143986     History of Changes
Other Study ID Numbers: CHUB-FERRITGLY01
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Francis Corazza, Brugmann University Hospital:
sepsis
Macrophagic activation syndrome
Ferritin
Still's disease

Additional relevant MeSH terms:
Syndrome
Sepsis
Arthritis, Juvenile
Still's Disease, Adult-Onset
Disease
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arthritis, Rheumatoid