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ClinicalTrials.gov ID

NCT05670301

Lead Sponsor

University Hospital, GhentOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

2,500Estimated

Last Update Posted

Sep 19, 2024Actual

Start Date

Sep 28, 2022Actual

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2029Estimated

Official Title

Flemish Joint Effort for Biomarker PRofiling in Inflammatory Systemic Diseases

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.

• Autoinflammatory Disease
• Autoimmune Diseases
• Inflammation

• cytokine and lipidomic profiling

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

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 Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, GhentOTHER

Collaborators

University Hospital, AntwerpOTHER

Ziekenhuis Netwerk Antwerpen (ZNA)OTHER

Universitair Ziekenhuis BrusselOTHER

Jessa HospitalOTHER

Hasselt UniversityOTHER

benson@uantwerp.be+32 3 821 32 51

benson@uantwerp.be+32 3 821 32 51