Flemish Joint Effort for Biomarker PRofiling in Inflammatory Systemic Diseases

NCT05670301 | Recruiting

• 1 other identifier: BC-11141
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 7

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.

Conditions

Autoinflammatory Disease; Autoimmune Diseases; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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

  On the sera of patients, the FEBRIS Cytokine Profile Assay will be performed. The FEBRIS Cytokine Profile Assay is a multiplex panel of inflammatory cytokines (interleukin (IL) 1 beta, IL-1RA, IL-6, IL-18, tumor necrosis factor (TNF) alpha, CXCL9 and CXCL10) that will be assessed by Meso Scale Discovery (MSD) technology. The concentration of cytokines will be quantified in pg/ml. Sera will be analyzed upon entry in the study and during follow-up (minimum interval of 3 months between samples). Data analyses (multiple logistic regression) will be performed on the cytokine fingerprints of different patient groups taking clinical control of patients into account (sampling during a flare of inflammation versus sampling during disease remission).

  full study period (up to 48 months)

Secondary Outcomes (10)

• 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

  full study period (up to 48 months)

• Registration of age

  full study period (up to 48 months)

• Registration of biological sex

  full study period (up to 48 months)

• Registration of weight

  full study period (up to 48 months)

• Registration of length

  full study period (up to 48 months)

Study Arms (1)

Intervention

EXPERIMENTAL

Cytokine assessment

Diagnostic Test: cytokine and lipidomic profiling

Interventions

cytokine and lipidomic profiling DIAGNOSTIC_TEST

* 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

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• An individual who meets any of the following criteria can be eligible for participation in this study:
• Child or adult
• Written informed consent
• Suspected or confirmed disease with systemic inflammation (acute, chronic and/or recurrent), these include:
• 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,…
• Autoimmune diseases (AI), including among others: systemic lupus erythematosus (SLE), juvenile dermatomyositis (JDM), rheumatoid arthritis (RA),…
• Hyperinflammatory diseases, including among others: hemophagocytic lymphohistiocytosis (HLH), macrophage activation syndrome (MAS), infection-related cytokine storm (e.g. in the setting of COVID-19)
• Other unidentified or not yet identified systemic inflammatory conditions
• Blood sample for diagnostic purposes is planned and possibility to acquire additional blood volume

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Confirmed localized infection and/or good response to first-line antibiotic treatment
• Confirmed malignancy

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Hospital, Antwerp: collaborator
• Ziekenhuis Netwerk Antwerpen (ZNA): collaborator
• Universitair Ziekenhuis Brussel: collaborator
• Jessa Hospital: collaborator
• Hasselt University: collaborator

Study Sites (7)

UZ Antwerpen

Antwerp, Belgium

RECRUITING

ZNA

Antwerp, Belgium

NOT YET RECRUITING

UZ Brussel

Brussels, Belgium

RECRUITING

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

UGent

Ghent, Belgium

ACTIVE NOT RECRUITING

Jessa Hospital

Hasselt, Belgium

RECRUITING

UHasselt

Hasselt, Belgium

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases; Inflammation

Condition Hierarchy (Ancestors)

Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Filomeen Haerynck

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filomeen Haerynck

CONTACT

+32 9 332 35 81; filomeen.haerynck@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Pseudonymisation of samples and clinical data for the investigator
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: January 4, 2023
• Study Start: September 28, 2022
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: at the end of the study period
• Access Criteria: open access

Locations

BE (7)