Flemish Joint Effort for Biomarker PRofiling in Inflammatory Systemic Diseases
University Hospital, Ghent
2,500 participants
Sep 28, 2022
INTERVENTIONAL
Conditions
Summary
A multi-centre, prospective study to study cytokine profiles and other potential disease-specific biomarkers in patients with presumed or confirmed diseases of systemic inflammation The goal of this prospective, observational study is to describe the longitudinal evolution of blood cytokine profiles in patients with presumed or confirmed diseases of systemic inflammation The main questions it aims to answer are: * What are the differences and similarities in blood cytokines between different patients and groups presenting symptoms of systemic inflammatory conditions? * How is the cytokine profile of individual patients evolving over time and what is the effect of different therapeutics? * Is cytokine profiling a valuable tool to diagnose and follow-up on patients with systemic inflammatory conditions? Participants will be asked to give an additional blood volume for research purposes when blood sampling is performed for routine clinical purposes. A subset of patients (those initiated on biologicals) will also be asked to complete questionnaires. Researchers will compare the blood cytokines profiles between the different groups of systemic inflammatory conditions and with healthy individuals.
Eligibility
Inclusion Criteria9
- An individual who meets any of the following criteria can be eligible for participation in this study:
- Child or adult
- Written informed consent
- Suspected or confirmed disease with systemic inflammation (acute, chronic and/or recurrent), these include:
- Autoinflammatory diseases (AID), including among others: systemic onset juvenile idiopathic arthritis (sJIA), familial mediterranean fever (FMF), mevalonate kinase deficiency (Hyper IgD syndrome), TNF receptor-associated periodic syndrome (TRAPS), familial Cold Autoinflammatory Syndrome (CAPS), type 1 interferonopathies,…
- Autoimmune diseases (AI), including among others: systemic lupus erythematosus (SLE), juvenile dermatomyositis (JDM), rheumatoid arthritis (RA),…
- Hyperinflammatory diseases, including among others: hemophagocytic lymphohistiocytosis (HLH), macrophage activation syndrome (MAS), infection-related cytokine storm (e.g. in the setting of COVID-19)
- Other unidentified or not yet identified systemic inflammatory conditions
- Blood sample for diagnostic purposes is planned and possibility to acquire additional blood volume
Exclusion Criteria4
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Confirmed localized infection and/or good response to first-line antibiotic treatment
- Confirmed malignancy
- Besides the above mentioned patients, volunteers that meet the requirements as a healthy individual are eligible for inclusion as controls.
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Interventions
* FEBRIS Cytokine Profile Assay (quantification of inflammatory cytokines) * Serum amyloid A * Biobanking of leftover sample for future analyses and specific immunofunctional assay in selected cases * Lipidomics
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT05670301