Profiling blood biomarkers in patients with systemic inflammatory diseases
Flemish Joint Effort for Biomarker PRofiling in Inflammatory Systemic Diseases
This study is testing how different blood markers change over time in people with systemic inflammatory diseases to improve diagnosis and treatment options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2500 (estimated) |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 7 sites (Antwerp and 6 other locations) |
| Trial ID | NCT05670301 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include children and adults with suspected or confirmed systemic inflammatory diseases such as autoinflammatory and autoimmune disorders.
Not a fit: Patients without systemic inflammatory conditions or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnosis and management of systemic inflammatory diseases through better understanding of cytokine profiles.
How similar studies have performed: Other studies have shown promise in using cytokine profiling for similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Antwerp and 6 other locations
- UZ Antwerpen — Antwerp, Belgium (Recruiting)
- Zna — Antwerp, Belgium (Not_yet_recruiting)
- UZ Brussel — Brussels, Belgium (Recruiting)
- Ghent University Hospital — Ghent, Belgium (Recruiting)
- UGent — Ghent, Belgium (Active_not_recruiting)
- Jessa Hospital — Hasselt, Belgium (Recruiting)
- UHasselt — Hasselt, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.