Clinical trial NCT05670301: Flemish Joint Effort for Biomarker PRofiling in Inflammatory Systemic Diseases
Official title: Flemish Joint Effort for Biomarker PRofiling in Inflammatory Systemic Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autoinflammatory Disease
Autoimmune Diseases
Inflammation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
name: Ziekenhuis Netwerk Antwerpen (ZNA)
name: Universitair Ziekenhuis Brussel
name: Jessa Hospital
name: Hasselt University
First posted: 2023-01-04
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Measurement of inflammatory cytokines (interleukin (IL) 1 beta, IL-1RA, IL-6, IL-18, tumor necrosis factor (TNF) alpha, CXCL9 and CXCL10) on serum of patients
timeFrame: full study period (up to 48 months)
Secondary outcomes:
measure: Additional measurement of inflammatory cytokines ((interleukin (IL) 1 beta, IL-1RA, IL-6, IL-18, tumor necrosis factor (TNF) alpha, CXCL9 and CXCL10) on serum of patients that are initiated on biological treatment
timeFrame: full study period (up to 48 months)
measure: Registration of age
timeFrame: full study period (up to 48 months)
measure: Registration of biological sex
timeFrame: full study period (up to 48 months)
measure: Registration of weight
timeFrame: full study period (up to 48 months)
measure: Registration of length
timeFrame: full study period (up to 48 months)
measure: Registration of confirmed or presumed inflammatory diseases
timeFrame: full study period (up to 48 months)
measure: Registration of clinical symptoms related to inflammatory diseases
timeFrame: full study period (up to 48 months)
measure: Registration of current therapy
timeFrame: full study period (up to 48 months)
measure: Registration of health-related costs
timeFrame: full study periode (up to 48 months)
measure: Registration of health-related quality of life
timeFrame: full study periode (up to 48 months)
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: UZ Antwerpen
city: Antwerp
country: Belgium
facility: ZNA
city: Brussels
country: Belgium
facility: UZ Brussel
city: Gent
country: Belgium
facility: UGent
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Hasselt
country: Belgium
facility: UHasselt
Study officials:
affiliation: University Ghent
name: Filomeen Haerynck
role: PRINCIPAL_INVESTIGATOR
References: