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Recruiting NCT05698173

Systemic Lupus Erythematosus and Accelerated Aging

No phase Interventional Systemic Lupus Erythematosus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood sample, blood sample.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The study aims at evaluating the phenomena of immune system aging in patients with Systemic lupus erythematosus.

Detailed description

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease characterized by a breakdown of tolerance against nuclear antigens. Thanks to improvements during the last decades in diagnosis, therapeutics and medical care, the lifespan of SLE patients has remarkably increased. However, standardized mortality ratio are still high in this population, with an increased mortality and morbidity associated with cardiovascular events and infectious events. Interestingly, these conditions are more commonly found during old age in the general population, raising the question of the presence of an acceleration of the aging process in SLE patients.

It has been demonstrated that the aging of the immune system, i.e. immunosenescence, is a key player in the development of many age-related diseases. The acceleration of immunosenescence, as it is observed during chronic viral infections for example, could favor the premature occurrence of clinical manifestations of accelerated aging. The exact contribution of such phenomenon in the context of SLE has, so far, never been explored.

Here, the investigators propose to perform a comprehensive study of the phenomena of immune system aging in patients with SLE in comparison to age-matched healthy controls.

The study will recruit 50 SLE patients followed in Bordeaux University Hospital. Among classical disease activity information, blood samples will be collected at study visit to extensively evaluate immune system aging. Fundamental research will be realized on patients' samples. Patients will be included within their usual follow-up. No extra visit will be needed, and blood samples will be drawn at the same time as those drawn for clinical purposes.

Interventions

  • Biological blood sample
    48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation
  • Biological blood sample
    blood for Peripheral blood mononuclear cell (PBMC) and serum isolation

Primary outcome measures

  • Absolute numbers of naïve T lymphocytes [Time frame: At baseline (Day 0)]
Secondary outcome measures (12)
  • Absolute numbers of terminally differentiated T lymphocytes [Time frame: At baseline (Day 0)]
  • Percentages of terminally differentiated T lymphocytes among total lymphocytes [Time frame: At baseline (Day 0)]
  • Percentages of senescent lymphocytes among total lymphocytes [Time frame: At baseline (Day 0)]
  • Telomere length in sorted CD4+ and CD8+ T lymphocytes subsets (naïve and memory) [Time frame: At baseline (Day 0)]
  • Frequency and phenotype of ELA-specific CD8+ T-cells after 10 days of in vitro priming [Time frame: At baseline (Day 0)]
  • Number of naïve T lymphocytes newly produced by thymus evaluated by T-cell receptor excision circles (TRECs) measurement [Time frame: At baseline (Day 0)]
  • Concentrations of senescence-associated secretory phenotype (SASP) markers in patients sera [Time frame: At baseline (Day 0)]
  • Presence or absence of anti-type I interferons autoantibodies in patients sera [Time frame: At baseline (Day 0)]
  • Measurement of disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [Time frame: At baseline (Day 0)]
  • Measurement of disease activity according to British Lupus Assessment Group Index 2004 (BILAG-2004) [Time frame: At baseline (Day 0)]
  • Quantification of organ damage according to SLICC/ACR Damage Index [Time frame: At baseline (Day 0)]
  • Levels of anti-double stranded DNA in patients sera [Time frame: At baseline (Day 0)]

Eligibility criteria

Inclusion criteria

  • male or female;
  • age between 18 and 60 years;
  • Lupus patient : diagnosis of systemic lupus erythematosus according to ACR or SLICC criteria;
  • being affiliated to health insurance;
  • willing to participate and to sign informed consent.

Exclusion criteria

  • pregnant or breastfeeding women;
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Bordeaux - Médecine Interne et Immunologie Clinique — Bordeaux

Identifiers

NCT: NCT05698173 · CHUBX 2022/53

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗