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NCT07680010Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 17 Jul 2026

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
105 (estimated)
First submitted
25 Jun 2026
Start date
1 Jul 2026
Primary completion date
31 Oct 2029
Lead sponsor
University Hospital, Bordeaux
Diseases
Lupus (SLE)
NCT number
NCT07680010

What you commit to

  • Study type: Interventional
  • Planned participants: 105
  • From 1 Jul 2026 to the primary completion date, 31 Oct 2029
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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

Age in the registry: 1 year to 18 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU de Bordeaux - Groupe hospitalier Pellegrin - Hôpital des enfants
Coordinator of this site? Confirm its status
BordeauxFranceUnknown status
CHU Toulouse Hôpital des Enfants
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.