NCT05698173

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Sep 2023Sep 2026

First Submitted

Initial submission to the registry

December 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

September 8, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

September 4, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

December 21, 2022

Last Update Submit

September 3, 2025

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosusAging

Outcome Measures

Primary Outcomes (1)

  • Absolute numbers of naïve T lymphocytes

    At baseline (Day 0)

Secondary Outcomes (13)

  • Absolute numbers of terminally differentiated T lymphocytes

    At baseline (Day 0)

  • Percentages of terminally differentiated T lymphocytes among total lymphocytes

    At baseline (Day 0)

  • Percentages of senescent lymphocytes among total lymphocytes

    At baseline (Day 0)

  • Telomere length in sorted CD4+ and CD8+ T lymphocytes subsets (naïve and memory)

    At baseline (Day 0)

  • Frequency and phenotype of ELA-specific CD8+ T-cells after 10 days of in vitro priming

    At baseline (Day 0)

  • +8 more secondary outcomes

Study Arms (2)

Systemic Lupus Erythematosus

EXPERIMENTAL

Diagnosis of systemic lupus erythematosus according to American College of Rheumatology (ACR) or SLICC criteria

Biological: blood sample

Controls

OTHER

Healthy controls

Biological: blood sample

Interventions

blood sampleBIOLOGICAL

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

Systemic Lupus Erythematosus

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux - Médecine Interne et Immunologie Clinique

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Noemie GENSOUS, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noemie GENSOUS, MD

CONTACT

(0)5 56 79 58 28noemie.gensous@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 26, 2023

Study Start

September 8, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 4, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)