Biomarkers in Autoimmune Diseases, Vasculitis and Auto Inflammatory Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
The objective of this work is to identify, in patients with autoimmune diseases, systemic vasculitis and autoinflammatory disease, cytokine and lymphocyte biomarkers of activity of these diseases to identify follow-up biomarkers, in order to personalize the follow-up and the treatments for each patient.
Immunological data will be obtained from biological samples collected as part of the usual patient care pathway (Blood and tissues sampling) The study will take place in the Department of Internal Medicine and Clinical Immunology (DMIIC), that is certified as the National Reference Centre for Rare Systemic Autoimmune Diseases and the National Reference Centre for Inflammatory Autoinflammatory Diseases and Inflammatory Amyloidosis (CEREMAIA). Its objective is to contribute to the advancement of fundamental knowledge in immunology, in particular to develop prognostic biomarkers of the activity of autoimmune diseases, systemic vasculitis and autoinflammatory diseases by using blood tests.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients of 18 years of age or older
Connectivities: lupus, Sjögren syndrome, antiphospholipid syndrome, mixed connectivity and Sharp syndrome, scleroderma, myositis
Vasculitis of large, small and medium vessels: giant cell arteritis, Takayasu arteritis, Behçet disease, ANCA vasculitis, cryoglobulinemic vasculitis, IgA vasculitis (rheumatoid purpura)
Buerger's disease (obliterating thromboangitis)
Disqualifiers
Persons deprived of liberty by judicial or administrative decision;
Persons receiving psychiatric care without their consent;
Adult subject to a legal protection measure (guardianship, curatorship);
Persons unable to give their consent.
Trial population
Adult patients with autoimmune diseases, systemic vasculitis and/or autoinflammatory disease
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Blood collection
Other intervention\- 56mL blood collected additionally to routine care
Treatment groups
2,250 Participants
are divided into 1 treatment groupGroup A: Patients1 intervention
Trial outcomes
Primary outcomes
1
Correlation between cytokine and lymphocyte profile and disease activity
Identification of new biomarkers of the activity of autoimmune diseases, systemic vasculitis and autoinflammatory diseases, using flux cytometry and ELISA analysis.
Time frame
through study completion, an average of 9 yearsSecondary outcomes
1
Characterization of new cytokines involved in these pathologies
Characterization of new cytokines involved in autoimmune diseases, systemic vasculitis and autoinflammatory diseases using ELISA analysis..
Time frame
through study completion, an average of 9 years2
Characterization of new lymphocytes types involved in these pathologies
Characterization of new lymphocytes types involved in autoimmune diseases, systemic vasculitis and autoinflammatory diseases using flux cytometry analysis.
Time frame
through study completion, an average of 9 years3
Correlation between the cytokine and lymphocyte profile, and the evolution of these pathologies (evolution towards mild forms, towards serious forms, death, frequency of relapses, etc.)
Determine predictive biomarkers of disease prognosis
Time frame
through study completion, an average of 9 years4
Correlation between the cytokine and lymphocyte profile, and the clinical presentation of each pathology
Establish associations between different molecular subtypes, clinicohistological factors and main clinical signs.
Time frame
through study completion, an average of 9 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Source ClinicalTrials.gov