Modeling the Early Stages of Autoimmunity Through the Study of Immunological Thrombocytopenic Purpura and Juvenile Lupus
PRELUDE
1 other identifier
interventional
105
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2026
CompletedFirst Posted
Study publicly available on registry
July 1, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2033
July 17, 2026
June 1, 2026
3.3 years
June 25, 2026
July 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Characterisation of B and T lymphocyte populations
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.
Baseline, Month 3 visit.
Plasma markers
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.
Baseline, Month 3 visit.
Plasma markers
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.
Baseline, Month 3 visit.
Secondary Outcomes (2)
Single-cell transcriptomic analysis
Baseline, Month 3 visit , Month 6 visit , Month 12 visit, Month 18 visit, Month 24 visit , Month 30 visit, Month 36 visit, Month 42 visit and Month 48 visit.
Single cell epigenetic analysis
Baseline, Month 3 visit , Month 6 visit , Month 12 visit, Month 18 visit, Month 24 visit , Month 30 visit, Month 36 visit, Month 42 visit and Month 48 visit.
Study Arms (4)
ITP-ANA-
OTHERITP-ANA+
OTHERSLE
OTHERControls
OTHERInterventions
Blood sampling is a routine biological procedure performed under the same conditions as during a follow-up consultation.
Monitoring for Systemic Lupus Erythematosus according to SLICC 2012 classification criteria
Blood sampling is a routine biological procedure performed under the same conditions as during a follow-up consultation.
Monitoring for Systemic Lupus Erythematosus according to SLICC 2012 classification criteria
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- Pregnant women, women in labour and breastfeeding women
- For controls :
- Suffering from an immunological disease,
- Immunomodulatory therapy.
- Pregnant women, women in labour and breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chu de Bordeaux- Groupe Hospitalier Pellegrin - Hôpital des Enfants
Bordeaux, 33076, France
CHU Toulouse - Hôpital des Enfants
Toulouse, 31026, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jérôme GRANEL, MD
University Hospital, Bordeaux
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2026
First Posted
July 1, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
October 1, 2033
Last Updated
July 17, 2026
Record last verified: 2026-06