Modeling the Early Stages of Autoimmunity Through the Study of Immunological Thrombocytopenic Purpura and Juvenile Lupus

NCT07680010 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Bordeaux

Phase

Not applicable

Started

2026-07

Last updated

2026-07-17

Condition(s) studied

Immune Thrombocytopenic Purpura ( ITP )Systemic Lupus Erythematosus (SLE)

Investigational drug(s) / intervention(s)

Blood sampling baseline and M3Monitoring for SLEProcedure/Surgery: Blood sampling baseline and M3 then each 6 months until 48 monthsmoniktoring for SLE : baseline and M3 then each 6 months until 48 months

Blood sampling baseline and M3: Blood sampling is a routine biological procedure performed under the same conditions as during a follow-up consultation.

Monitoring for SLE: Monitoring for Systemic Lupus Erythematosus according to SLICC 2012 classification criteria

Procedure/Surgery: Blood sampling baseline and M3 then each 6 months until 48 months: Blood sampling is a routine biological procedure performed under the same conditions as during a follow-up consultation.

moniktoring for SLE : baseline and M3 then each 6 months until 48 months: Monitoring for Systemic Lupus Erythematosus according to SLICC 2012 classification criteria

Study summary

Immunologic thrombocytopenic purpura (ITP) in children is a pre-lupus condition if associated with the presence of anti-nuclear antibodies (ANA), providing a unique model for understanding the natural history of autoimmunity, particularly that of systemic lupus erythematosus (SLE). The investigators will describe the shared and/or unique immunological pathways involved at diagnosis in 70 children with ITP and in 20 children with SLE, and compare them between ITP-ANA- (more often transient), ITP-ANA+ (pre-lupus condition, more often persistent) and SLE

Eligibility

Sex

ALL

Min age

1 Year

Max age

18 Years

Healthy volunteers

Accepted

* Inclusion criteria: * For patients : * Child or adolescent with newly diagnosed ITP or SLE according to the specific definitions of ITP or SLE, prior to any treatment, * Over 1 and under 18 years of age at diagnosis, weighing more than 7 kg. * Written consent from parents or guardians, * Patient affiliated to a social security scheme. * For controls : * Over 1 and under 18 years of age at diagnosis, weighing more than 7 kg. * Follow-up in the day hospital at the Bordeaux University Hospital, for a condition that does not affect the immune system * Matched on age, * Written consent from parents or guardians, * Patient affiliated to a social security scheme * Exclusion criteria: * For patients : * ITP secondary to a known cause: previous or concomitant immune deficiency, bone marrow or organ transplantation, other autoimmune disease, Evans syndrome (autoimmune hemolytic anemia or autoimmune neutropenia present at ITP diagnosis) or cancer with immunosuppressive therapy. * Treatment with immunomodulation or immunosuppressants (including immunoglobulins, corticoids, hydroxychloroquine), started prior to inclusion (day of sampling). * Pregnant women, women in labour and breastfeeding women * For controls : * Suffering from an immunological disease, * Infection within fifteen days prior to inclusion, * Immunomodulatory therapy. * Pregnant women, women in labour and breastfeeding women

Primary outcome measure(s)

Characterisation of B and T lymphocyte populations — Baseline, Month 3 visit.
Characterisation of B and T lymphocyte populations through the study of surface markers and intracellular factors. This panel will, in particular, enable the identification of effector B cells such as plasma blasts, subsets of auto-reactive 'double-negative' (DN) B cells, regulatory B cells, and follicular T helper (Tfh) and peripheral extra-follicular T helper (Tph) cells. Each population will be compared between the patients and the control group.
Plasma markers — Baseline, Month 3 visit.
Soluble cytokines and factors regulating B-cell survival (BAFF, TACI, IL-6, IL-12p70, IFN-γ, IFN-β, TGF-β, and the IFN-regulated chemokine CXCL10) will be quantified in plasma using a customised multiplex Luminex assay. Interferon alpha levels will be specifically measured using ultra-sensitive SIMOA (Single Molecule Array) technology.
Plasma markers — Baseline, Month 3 visit.
Circulating plasma autoantigens - soluble P-selectin and CD40L derived from platelet activation - will be measured by ELISA. The levels of circulating and mitochondrial DNA will be measured by quantitative RT-PCR in collaboration with V. Sisirak (DR CNRS, Immunoconcept). The overall activity of plasma DNases will be determined by an in vitro DNA degradation assay.

Trial sites (2)

Facility	City	Region	Status
Chu de Bordeaux- Groupe Hospitalier Pellegrin - Hôpital des Enfants	Bordeaux	France
CHU Toulouse - Hôpital des Enfants	Toulouse	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07680010 on ClinicalTrials.gov ↗ ← All trials in France