- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02143986
Glycosylated Ferritin in Macrophagic Activation Syndromes (FERRITGLY01)
Glycosylated Ferritin in Differential Diagnosis of Still's Disease, Sepsis and Other Macrophagic Activation Syndromes.
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.
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Francis Corazza, MD, PhD
- Phone Number: 32-2-4772506
- Email: francis.corazza@ulb.ac.be
Study Contact Backup
- Name: France Debaugnies, Pharm
- Phone Number: 32-2-4772507
- Email: france.debaugnies@chu-brugmann.be
Study Locations
-
-
-
Brussels, Belgium, 1020
- Recruiting
- Brugmann University Hospital
-
Contact:
- Francis Corazza, MD PhD
- Email: francis.corazza@ulb.ac.be
-
Contact:
- France Debaugnies, Pharm
- Email: france.debaugnies@chu-brugmann.be
-
Principal Investigator:
- francis Corazza, MD PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Suspicion of sepsis, macrophagic activation syndrome, Still's disease or hyperferritinemia (malignant disease, hepatic cytolysis)
Exclusion Criteria:
- Normal ferritin level
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Sepsis
|
Macrophagic activation syndrome
|
Still's disease
|
Hyperferritinemia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fraction of glycosylated ferritin in serum
Time Frame: One year
|
One year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Immune System Diseases
- Autoimmune Diseases
- Systemic Inflammatory Response Syndrome
- Inflammation
- Disease
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Sepsis
- Syndrome
- Arthritis, Juvenile
- Still's Disease, Adult-Onset
Other Study ID Numbers
- CHUB-FERRITGLY01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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