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Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis (MICROLUPS)

U

University Hospital of Bordeaux

Status

Completed

Conditions

Systemic Scleroderma
Systemic Lupus Erythematosus

Treatments

Biological: urine sample
Biological: blood sample

Study type

Interventional

Funder types

Other

Identifiers

NCT03575156
CHUBX 2017/54

Details and patient eligibility

About

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.

Full 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.

Enrollment

208 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • diagnosis of systemic lupus erythematosus or systemic sclerosis;
  • age ≥ 18 years;
  • being affiliated to health insurance, willing to participate and to sign informed consent.

Exclusion criteria

  • pregnant or breastfeeding women;
  • patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

208 participants in 2 patient groups

Systemic lupus erythematosus (SLE)
Experimental group
Treatment:
Biological: urine sample
Biological: blood sample
systemic scleroderma (SSc)
Experimental group
Treatment:
Biological: urine sample
Biological: blood sample

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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