Profiling blood biomarkers in patients with systemic inflammatory diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-centre, prospective study aims to investigate cytokine profiles and other potential disease-specific biomarkers in patients with presumed or confirmed systemic inflammatory diseases. Researchers will longitudinally assess blood samples to identify differences in cytokine levels among patients and track how these profiles evolve over time with various treatments. The study will utilize the FEBRIS Cytokine Profile Assay to measure inflammatory markers and integrate these findings with clinical data to enhance diagnosis and treatment strategies for systemic inflammation. Participants will provide additional blood samples during routine clinical blood draws for research purposes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

An individual who meets any of the following criteria can be eligible for participation in this study:

1. Child or adult
2. Written informed consent
3. Suspected or confirmed disease with systemic inflammation (acute, chronic and/or recurrent), these include:

   1. 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,…
   2. Autoimmune diseases (AI), including among others: systemic lupus erythematosus (SLE), juvenile dermatomyositis (JDM), rheumatoid arthritis (RA),…
   3. Hyperinflammatory diseases, including among others: hemophagocytic lymphohistiocytosis (HLH), macrophage activation syndrome (MAS), infection-related cytokine storm (e.g. in the setting of COVID-19)
   4. Other unidentified or not yet identified systemic inflammatory conditions
4. Blood sample for diagnostic purposes is planned and possibility to acquire additional blood volume

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Confirmed localized infection and/or good response to first-line antibiotic treatment
2. Confirmed malignancy

Besides the above mentioned patients, volunteers that meet the requirements as a healthy individual are eligible for inclusion as controls.

Where it's running

• UZ Antwerpen
  Antwerp, Belgium Recruiting
• UZ Brussel
  Brussels, Belgium Recruiting
• Ghent University Hospital
  Ghent, Belgium Recruiting
• Jessa Hospital
  Hasselt, Belgium Recruiting
• Zna
  Antwerp, Belgium Not yet recruiting
• UGent
  Ghent, Belgium Active not recruiting

Study contacts

• Principal investigator: Filomeen Haerynck — University Ghent
• Study coordinator: Filomeen Haerynck
• Email: filomeen.haerynck@ugent.be
• Phone: +32 9 332 35 81

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.