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