Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT03575156
Brief Summary:
Our study aims at defining the role of circulating microparticles in the physiopathology of two rare auto-immune diseases: systemic lupus erythematosus (SLE) and systemic scleroderma (SSc). Microparticles might have an prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.
Detailed Description:
Systemic lupus erythematosus (SLE) and systemic scleroderma (SSc) are two rare and potentially life-threatening auto-immune systemic diseases. There is an urgent need to describe prognostic factors and to discover new therapeutic pathways. Microparticles (MPs) are small extracellular vesicles formed from activated cells including endothelial cells and platelets. Preliminary data from our lab indicate that these MPs might play a key role in SLE and SSc physiopathology. In fact, MPs from patients with SLE aggregates with T regulator lymphocytes (LTregs) and decrease their activity, thereby promoting auto-immunity. Some works also indicate that MPs might cargo DNA to the immune system, also promoting auto-immunity. The investigators hypothesized that MPs levels might be a prognostic factor in SLE and SSc and that studying the molecular mechanisms involved could provide new therapeutic targets.
Our study will recruit 100 patients with SLE or SSc followed in Bordeaux University Hospital. Among classical disease activity information, blood and urine samples will be collected at each visit to study circulating microparticles. Fundamental research will be realized on patients' sample to study molecular mechanisms involved.
Clinical and biological disease activity, treatment and outcomes will be studied in correlation with MPs to describe their potential prognostic role. Patients will be followed at regular intervals as their usual follow-up would request. No extra visit will be needed and blood samples will be drawn at the same times as those drawn for clinical purposes.
Study:
NCT03575156
Study Brief:
Protocol Section:
NCT03575156