Actively Recruiting
Characterization of a Functional Test for Mediterranean Family Fever Screening - 2
Led by Hospices Civils de Lyon · Updated on 2024-07-19
160
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Familial Mediterranean fever (FMF) is a common auto-inflammatory disease caused by mutations in the MEFV gene, which affects the Pyrine inflammasome involved in immune response. Researchers are evaluating a quick and simple functional test that measures interleukin-1b2 activation to help diagnose FMF and distinguish different genetic mutations in patients. This study aims to better characterize this test's ability to screen for FMF mutations. The study involves collecting an additional blood sample during a routine blood test, with 4 ml taken for children under 12 and 10 ml for those 12 and over, including adults. Participants include children and adults with FMF and healthy blood donors. The research does not alter usual care and focuses on correlating genotype and phenotype through this functional test. Participants will have their interleukin-1b2 levels measured at inclusion using this blood sample. The study requires no changes to regular treatment and poses no additional risk beyond the extra blood draw. The study is observational, with healthy volunteers included for comparison, and will continue until July 2029 as researchers analyze the test's diagnostic capabilities and genotype correlations.
CONDITIONS
Brief Title
Characterization of a Functional Test for Mediterranean Family Fever Screening - 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children 4 years of age or older or adults
- Clinical signs compatible with Familial Mediterranean Fever
- Previous genetic analysis showing at least one pathogenic or possibly pathogenic MEFV gene mutation
- Newly diagnosed or in follow-up care with no time limit
- Receiving specific, non-specific treatment, or no treatment
- Planned blood test as part of routine care
- Provided informed non-opposition (or parental non-opposition for minors)
You will not qualify if you...
- Under legal protection or guardianship
- Unable to give consent
- In an emergency situation
- Known infections with HIV, HBV, or HCV
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.
Duration - Duration of routine care as planned by participants' healthcare providers
Participants who undergo routine care are observed. An additional blood sample is collected during a planned blood test to support research without changing usual care.
1 additional blood sample collected during a planned blood test
Trial Site Locations
Total: 8 locations
1
Hôpital Femme-Mère-Enfant
Bron, France, 69677
Actively Recruiting
2
CH de Versailles - Hôpital André Mignot
Le Chesnay, France, 78157
Not Yet Recruiting
3
Hôpital Edouard Herriot
Lyon, France, 69008
Not Yet Recruiting
4
Hôpital de la Croix-Rousse
Lyon, France, 69317
Actively Recruiting
5
CHU de Montpellier
Montpellier, France, 34295
Not Yet Recruiting
6
Service de Pédiatrie - CHU de Nîmes - Hôpital Carémeau
Nîmes, France, 30029
Not Yet Recruiting
7
Hôpital Tenon
Paris, France, 75020
Actively Recruiting
8
Hôpital Lyon Sud
Pierre-Bénite, France, 69495
Not Yet Recruiting
Research Team
Y
Yvan Jamilloux, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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