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Not Yet Recruiting NCT07680010

Model Early Immunologic Stages of Pediatric Hematological Pre-lupus

Conditions: Immune Thrombocytopenic Purpura ( ITP ), Systemic Lupus Erythematosus (SLE)

Sex: All
Ages: 1 Year – 18 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 105
Sponsor: University Hospital, Bordeaux

Location: Chu de Bordeaux- Groupe Hospitalier Pellegrin - Hôpital des Enfants Bordeaux

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). We 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 Criteria

* 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

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Source: ClinicalTrials.gov (NCT07680010). StuddyBuddy aggregates publicly available trial information.