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
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Bordeaux - Groupe hospitalier Pellegrin - Hôpital des enfants Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHU Toulouse Hôpital des Enfants Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.