Actively Recruiting
Flemish Joint Effort for Biomarker Profiling in Inflammatory Systemic Diseases
Led by University Hospital, Ghent · Updated on 2024-09-19
2500
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
U
University Hospital, Antwerp
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying cytokine profiles and other potential biomarkers in patients with presumed or confirmed systemic inflammatory diseases. This prospective, observational study involves multiple centers in Flanders, Belgium, aiming to understand differences and changes in blood cytokines over time among various inflammatory conditions, and to assess the usefulness of cytokine profiling for diagnosis and monitoring. The study includes patients with autoinflammatory diseases, autoimmune diseases, hyperinflammatory syndromes, and systemic infections, alongside healthy controls for comparison. Participants will undergo blood sampling for cytokine and lipidomic profiling using the FEBRIS Cytokine Profile Assay, which measures various pro- and anti-inflammatory cytokines, along with serum amyloid A quantification. Blood samples will be collected every 3 to 6 months for up to four years, with additional leftover samples stored for future analyses. Patients starting biological treatments will also complete questionnaires about their health-related quality of life to help understand treatment effects and improve care. During the study, participants will provide blood samples when routine clinical blood draws occur, and researchers will collect clinical information such as age, sex, weight, disease status, symptoms, therapies, and health costs. The main outcome is the measurement of specific inflammatory cytokines in serum over the study period. The study monitors participants longitudinally, correlating biomarker data with clinical and genetic diagnoses and treatment responses, with involvement lasting up to 48 months.
CONDITIONS
Brief Title
Flemish Joint Effort for Biomarker PRofiling in Inflammatory Systemic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child or adult
- Written informed consent
- Suspected or confirmed systemic inflammatory disease, including autoinflammatory diseases, autoimmune diseases, hyperinflammatory diseases, or other systemic inflammatory conditions
- Planned blood sample for diagnostic purposes with possibility to collect additional blood volume
You will not qualify if you...
- Confirmed localized infection with good response to first-line antibiotic treatment
- Confirmed malignancy
- Healthy volunteers may be included as controls if they meet healthy individual requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 months
Participants undergo blood sampling to measure inflammatory cytokines and other biomarkers for diagnostic purposes.
Blood samples collected every 3 to 6 months and additional samples collected during routine clinical blood draws
Duration - Up to 48 months
Participants are followed longitudinally with repeated blood sampling and assessments to correlate biomarkers with clinical outcomes and therapeutic effects.
Blood sampling every 3 to 6 months with additional questionnaires for participants starting biological treatment
Trial Site Locations
Total: 7 locations
1
UZ Antwerpen
Antwerp, Belgium
Actively Recruiting
2
ZNA
Antwerp, Belgium
Not Yet Recruiting
3
UZ Brussel
Brussels, Belgium
Actively Recruiting
4
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
5
UGent
Ghent, Belgium
Active, Not Recruiting
6
Jessa Hospital
Hasselt, Belgium
Actively Recruiting
7
UHasselt
Hasselt, Belgium
Active, Not Recruiting
Research Team
F
Filomeen Haerynck
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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