Immune Thrombocytopenic Purpura ( ITP )PRELUDENCT07680010
Modeling the Early Stages of Autoimmunity Through the Study of Immunological Thrombocytopenic Purpura and Juvenile Lupus
A study testing Blood sampling baseline and M3, Monitoring for SLE and Procedure/Surgery: Blood sampling baseline and M3 then each 6 months until 48 months in people with Immune Thrombocytopenic Purpura ( ITP ) and Systemic Lupus Erythematosus (SLE), run by University Hospital, Bordeaux at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Thrombocytopenic Purpura ( ITP ), Systemic Lupus Erythematosus (SLE)
- What is being tested?
- Blood sampling baseline and M3, Monitoring for SLE and Procedure/Surgery: Blood sampling baseline and M3 then each 6 months until 48 months
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2026to Oct 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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 :
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- 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
Who cannot join
- 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,
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- Infection within fifteen days prior to inclusion,
- Immunomodulatory therapy.
- Pregnant women, women in labour and breastfeeding women
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nathalie ALADJIDI, MD contact
France2 sites
Chu de Bordeaux- Groupe Hospitalier Pellegrin - Hôpital des Enfants
Bordeaux, 33076
Jérôme GRANEL, MD, +33 5 57 82 02 55, jerome.granel@chu-bordeaux.fr
CHU Toulouse - Hôpital des Enfants
Toulouse, 31026
Marlène PASQUET, PROF, +33 5 34 55 86 43, pasquet.m@chu-toulouse.fr
About this study
Official title: Modeling the Early Stages of Autoimmunity Through the Study of Immunological Thrombocytopenic Purpura and Juvenile Lupus PRELUDE
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
Read the detailed description
The development of an autoimmune disease (AID) requires several years. In systemic lupus erythematosus (SLE), anti-nuclear antibodies (ANA) appear several years before the onset of the disease. However, it is difficult to identify the early mechanisms of autoimmunity in humans as most patients' samples are obtained at the time of diagnosis.
The investigators hypothesize that immune thrombocytopenic purpura (ITP) in children provides a unique model for understanding the initial mechanisms leading to autoimmunity. Children with ITP have common immune system dysfunctions leading to the production of anti-platelet antibodies. However, despite this supposedly common dysfunction, the course and degree of loss of tolerance of the immune system are very heterogeneous: the disease is transient in 75 to 80% of cases, and 15 to 20% of children with ITP have ANA and their course is usually persistent or chronic. This subgroup of children with hematological AID, ITP ANA+ meets the criteria for a broader form of AID: pre-lupus. The investigators have recently shown that 16% of these children with pre-lupus / ITP-ANA+ progressed to complete SLE within a median of 3.8 years. Why do some children have transient or persistent ITP? limited or systemic ITP? The investigators aim to describe the shared and/or unique immunological pathways involved at diagnosis in children with ITP ANA- (transient or persistent), with ITP ANA+ (pre-lupus condition, transient or persistent), and in patients with SLE (persistent by definition) In this exploratory, prospective, bi-centric cohort study, the investigators will include 70 children with ITP and 20 children with SLE newly diagnosed, over 36 months with a 3-month follow-up for children with ITP-ANA- and SLE and a 48-month follow-up for children with ITP-ANA+. ANA positivity will be defined by a titer ≥ 1/160. Blood samples will be collected at inclusion and at 3 months (bio-collection), and further each 6 months for children with ITP-ANA+. ITP status will be defined at 3 months: transient or persistent. The investigators will analyze the signaling pathways (B and T lymphocytes, cytokines, disruption of tolerance and inactivation of X) involved in these different pathophysiological distinct subgroups
- Being tested
- Blood sampling baseline and M3, Monitoring for SLE, Procedure/Surgery: Blood sampling baseline and M3 then each 6 months until 48 months, moniktoring for SLE : baseline and M3 then each 6 months until 48 months
- Keywords
- Children, Immunologic Thrombocytopenic Purpura, Anti-Nuclear Antibody, Systemic Lupus Erythematosus, Biomarkers
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling baseline and M3Procedure or surgery
Blood sampling is a routine biological procedure performed under the same conditions as during a follow-up consultation.
Monitoring for SLEOther
Monitoring for Systemic Lupus Erythematosus according to SLICC 2012 classification criteria
Procedure/Surgery: Blood sampling baseline and M3 then each 6 months until 48 monthsProcedure or surgery
Blood sampling is a routine biological procedure performed under the same conditions as during a follow-up consultation.
moniktoring for SLE : baseline and M3 then each 6 months until 48 monthsOther
Monitoring for Systemic Lupus Erythematosus according to SLICC 2012 classification criteria
| Study group | Role | What they receive |
|---|---|---|
| ITP-ANA- | Other | Not described Receives: Procedure: Blood sampling baseline and M3; Other: Monitoring for SLE |
| ITP-ANA+ | Other | Not described Receives: Procedure: Procedure/Surgery: Blood sampling baseline and M3 then each 6 months until 48 months; Other: moniktoring for SLE : baseline and M3 then each 6 months until 48 months |
| SLE | Other | Not described Receives: Procedure: Blood sampling baseline and M3; Other: Monitoring for SLE |
| Controls | Other | Not described Receives: Procedure: Blood sampling baseline and M3; Other: Monitoring for SLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 3 visit.
Secondary outcomes (2)
Single-cell transcriptomic analysis
Using single-cell RNA sequencing, a single-cell transcriptomic analysis, we will be able to quantify and analyse the transcriptomes of lymphocytes B This will enable us to characterise heterogeneous cell populations, as well as to reconstruct cell development pathways and model transcriptomic dynamics.
This technique will enable the modelling of signalling pathways involving B lymphocytes in the subgroup of ITP patients with positive AAN titres, and the development of an algorithm and a mathematical model of the progression of these cellular and molecular markers
Measured: 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
Using single-cell ATAC sequencing, we will be able to analyse the regions of DNA accessible to the transcription machinery. This will enable us to identify regulatory programmes such as signalling pathways. The analysis will also reveal heterogeneity amongst B-cell subpopulations, which may respond differently to signals.
This will provide insight into the epigenetic status of genes, or at least into which factors regulate this signalling pathway and how the cell adjusts its response depending on its situation or stage of maturity, or on the signal itself.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenic Purpura ( ITP )Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme GRANEL, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680010
- Sponsor's protocol ID
- CHUBX 2025/052
- Acronym
- PRELUDE
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling the Early Stages of Autoimmunity Through the Study of Immunological Thrombocytopenic Purpura and Juvenile Lupus PRELUDE
- ClinicalTrials.gov ID
- NCT07680010
- Acronym / sponsor ID
- PRELUDE / CHUBX 2025/052
- Keywords
- Children, Immunologic Thrombocytopenic Purpura, Anti-Nuclear Antibody, Systemic Lupus Erythematosus, Biomarkers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2033 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The development of an autoimmune disease (AID) requires several years. In systemic lupus erythematosus (SLE), anti-nuclear antibodies (ANA) appear several years before the onset of the disease. However, it is difficult to identify the early mechanisms of autoimmunity in humans as most patients' samples are obtained at the time of diagnosis.
The investigators hypothesize that immune thrombocytopenic purpura (ITP) in children provides a unique model for understanding the initial mechanisms leading to autoimmunity. Children with ITP have common immune system dysfunctions leading to the production of anti-platelet antibodies. However, despite this supposedly common dysfunction, the course and degree of loss of tolerance of the immune system are very heterogeneous: the disease is transient in 75 to 80% of cases, and 15 to 20% of children with ITP have ANA and their course is usually persistent or chronic. This subgroup of children with hematological AID, ITP ANA+ meets the criteria for a broader form of AID: pre-lupus. The investigators have recently shown that 16% of these children with pre-lupus / ITP-ANA+ progressed to complete SLE within a median of 3.8 years. Why do some children have transient or persistent ITP? limited or systemic ITP? The investigators aim to describe the shared and/or unique immunological pathways involved at diagnosis in children with ITP ANA- (transient or persistent), with ITP ANA+ (pre-lupus condition, transient or persistent), and in patients with SLE (persistent by definition) In this exploratory, prospective, bi-centric cohort study, the investigators will include 70 children with ITP and 20 children with SLE newly diagnosed, over 36 months with a 3-month follow-up for children with ITP-ANA- and SLE and a 48-month follow-up for children with ITP-ANA+. ANA positivity will be defined by a titer ≥ 1/160. Blood samples will be collected at inclusion and at 3 months (bio-collection), and further each 6 months for children with ITP-ANA+. ITP status will be defined at 3 months: transient or persistent. The investigators will analyze the signaling pathways (B and T lymphocytes, cytokines, disruption of tolerance and inactivation of X) involved in these different pathophysiological distinct subgroups
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ITP-ANA- | Other | Procedure: Blood sampling baseline and M3, Other: Monitoring for SLE |
| ITP-ANA+ | Other | Procedure: Procedure/Surgery: Blood sampling baseline and M3 then each 6 months until 48 months, Other: moniktoring for SLE : baseline and M3 then each 6 months until 48 months |
| SLE | Other | Procedure: Blood sampling baseline and M3, Other: Monitoring for SLE |
| Controls | Other | Procedure: Blood sampling baseline and M3, Other: Monitoring for SLE |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
Key exclusion criteria (9 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling baseline and M3Blood sampling is a routine biological procedure performed under the same conditions as during a follow-up consultation. | Procedure or surgery | Controls, ITP-ANA-, SLE |
| Monitoring for SLEMonitoring for Systemic Lupus Erythematosus according to SLICC 2012 classification criteria | Other | Controls, ITP-ANA-, SLE |
| Procedure/Surgery: Blood sampling baseline and M3 then each 6 months until 48 monthsBlood sampling is a routine biological procedure performed under the same conditions as during a follow-up consultation. | Procedure or surgery | ITP-ANA+ |
| moniktoring for SLE : baseline and M3 then each 6 months until 48 monthsMonitoring for Systemic Lupus Erythematosus according to SLICC 2012 classification criteria | Other | ITP-ANA+ |
Primary outcome
Characterisation of B and T lymphocyte populations
Time frame: Baseline, Month 3 visit.
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.
Plasma markers
Time frame: Baseline, Month 3 visit.
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.
Plasma markers
Time frame: Baseline, Month 3 visit.
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.
2 secondary outcomes
Single-cell transcriptomic analysis
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathalie ALADJIDI, MD contact
Jérôme GRANEL, MD principal investigator
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling baseline and M3, Monitoring for SLE and Procedure/Surgery: Blood sampling baseline and M3 then each 6 months until 48 months in people with Immune Thrombocytopenic Purpura ( ITP ) and Systemic Lupus Erythematosus (SLE), run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jérôme GRANEL, MD (+33 5 57 82 02 55, jerome.granel@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterisation of B and T lymphocyte populations (time frame: Baseline, Month 3 visit.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.