Familial Mediterranean Fever Clinical Trial
— DEPIST-FMFOfficial title:
Assessment of a Functional Test to Detect Familial Mediterranean Fever
Verified date | June 2021 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Familial Mediterranean Fever (FMF) is the most common auto-inflammatory disease (prevalence: 1-5 / 10,000 inhabitants). It is due to mutations of the MEFV gene, encoding variants of the Pyrin inflammasome. Inflammasomes are protein complexes of innate immunity producing pro-inflammatory cytokines (interleukin-1β). In vitro, preliminary results demonstrated that activation of the Pyrin inflammasome (measured by interleukin-1β concentration) by kinase inhibitors is significantly increased in FMF patients compared to subjects with a similar clinical picture, and healthy controls. In addition, a measure of cell death yielded significant results in differentiating patients from controls. The investigators hypothesize that this fast and simple functional test can serve as a diagnostic tool for FMF.
Status | Completed |
Enrollment | 107 |
Est. completion date | December 15, 2020 |
Est. primary completion date | December 15, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years and older |
Eligibility | Inclusion Criteria: - Clinical picture compatible with an Familial Mediterranean Fever and an earlier genetic analysis finding a mutation of the MEFV gene; - Newly diagnosed or undergoing follow-up (without criteria of delay or evolutionary stage); - In the course of specific or non-specific treatment of the disease or without treatment; - For whom a blood test is planned as part of the routine care; - Of whom the informed non-opposition has been collected (parental authorization in the case of a minor patient); Exclusion Criteria: - patient under legal protection or under safeguard of justice or any other measures of protection (guardianship, curatorship); - Person unable to express his consent; - Person in emergency situation, vital or not; - Infection known to HIV and / or HBV and / or HCV |
Country | Name | City | State |
---|---|---|---|
France | Service de néphrologie et rhumatologie pédiatrique, Hôpital Femme Mère Enfant | Bron | |
France | Service de Médecine Interne, Pavillon O - Hopital Edouard Herriot | Lyon | |
France | Unité Inserm U1111 & Service de Médecine Interne, Hôpital de la Croix-Rousse | Lyon | |
France | Service de Médecine Interne et pathologies vasculaires, Batiment 1B, Centre Hospitalier Lyon Sud | Pierre-Bénite |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences in interleukin-1bß levels | Quantification of the capacity of interleukin-1ß concentration measured in primary monocyte supernatants in response to kinase inhibitors, to discriminate Familial Mediterranean Fever subjects from control subjects (healthy subjects and subjects with symptoms similar to those of Familial Mediterranean Fever).
Analysis have to be performed Less than 48 hours after blood sampling (only one sampling). |
Less than 48 hours |
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