NCT05670301

Flemish Joint Effort for Biomarker PRofiling in Inflammatory Systemic Diseases

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

FEBRIS is a prospective, observational and multi-centric study involving 5 hospitals in Flanders, Belgium. In this study, the researchers will us ehe FEBRIS Cytokine Profile Assay, which is a multiplex assay measuring pro- and anti-inflammatory cytokines in the blood of subjects. It has been developed in a retrospective cohort of human patients presenting systemic inflammatory disorders. With this study, the researchers aim to prospectively validate the use of this assay in a cohort of patients that present signs reminiscent of systemic inflammation, including patients with antoinflammatory conditions, autoimmune disorders, hyperinflammatory syndromes (e.g. hemophagocytic lymphohistiocytosis and macrophage activation syndrome) and systemic infection. In parallel, serum amyloid A will be quantified in all patients. Lipidomics will be performed on patients with sufficient leftover sample. The researchers will integrate the data from these assays with clinical parameters at baseline and during follow-up to correlate markers with the clinical or genetic diagnosis, prognosis and effect of different therapeutics. Patients fulfilling the inclusion criteria are eligible for longitudinal blood sampling (every 3-6 months) during the study period (maximum of 4 years). Additional clotted blood will only be collected when a blood sample for routine clinical purposes is performed. In addition, patients initiated on biological therapeutics will be asked to complete questionnaires regarding health-related quality of life to document outcome and improve rational and cost-efficient use of additional investigations and treatment.

Conditions

• Autoinflammatory Disease
• Autoimmune Diseases
• Inflammation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	cytokine and lipidomic profiling	* 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

Timeline

• Start date: 2022-09-28
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2023-01-04
• Last updated: 2024-09-19

Locations

7 sites across 1 country: Belgium