Département de Médecine Interne et Immunologie Clinique (DMIIC), Hôpital Pitié-Salpêtrière
Paris, France, 75013
Location status: Recruiting
Location contact
David Saadoun, Professor
CONTACT
Nassima Mansour
CONTACT
NCT Number: NCT05383339
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Paris, France, 75013
Location status: Recruiting
David Saadoun, Professor
CONTACT
Nassima Mansour
CONTACT
Autoimmune systemic diseases, systemic vasculitis and autoinflammatory diseases are diseases involving the innate and adaptive immune systems. The pro and anti-inflammatory cytokines, and the T and B lymphocytes appear as key actors of these pathologies, at the interface between the innate and adaptive immune system. The evolutionary profile of patients is highly variable, with some patients with minor forms mainly affecting the skin and joints for example, and others with potentially serious organ damage (e.g., renal involvement in lupus or vasculitis). At this time, we do not have markers to identify patients who will exhibit severe forms. Besides, treatments have evolved a lot over the years and mainly aime at controlling inflammation, either through non-target treatments (conventional immunosuppressants) or targeted biotherapies (anti-TNF, anti-interleukin 6, etc.). However, these treatments have in common to be suspensive in the majority of cases and the systemic diseases described tend to relapse frequently without clearly identifying clinical or biological factors predicting relapse. Patients are therefore exposed to treatments with many short-, medium- and long-term side effects without being able to identify precisely which patients benefit and which patients do not need further treatment.
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 samples and tissues sampling) The Department of Internal Medicine and Clinical Immunology (DMIIC) 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). It has a fundamental research laboratory dedicated to the immunology of translational systems. Its objective is to contribute to the advancement of fundamental knowledge in immunology and in particular to develop prognostic biomarkers of the activity of autoimmune diseases, systemic vasculitis and autoinflammatory diseases by using blood tests. Several thousand patients with various autoimmune and autoinflammatory diseases are followed in the DMIIC, making the Department particularly suitable for this type of research.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: through study completion, an average of 9 years
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 years
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 years
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 years
Determine predictive biomarkers of disease prognosis
Time frame: through study completion, an average of 9 years
Establish associations between different molecular subtypes, clinicohistological factors and main clinical signs.
Time frame: through study completion, an average of 9 years
Establish a molecular classification specific to each type of pathology: autoimmune diseases, systemic vasculitis and autoinflammatory diseases
Contact information is provided by the study sponsor or research team.
David Saadoun, Professor
CONTACT
Nassima Mansour
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: BIOMAI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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