ClinicalTrials.gov record NCT05937828

OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

"French National Cohort of Patients With Pediatric-onset of Autoimmune Cytopenia (OBS'CEREVANCE Cohort)"

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Jul 10, 2023, about 3 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
AgeUp to 17 years old
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

A national, prospective cohort collecting real-world data on children diagnosed before age 18 with immune thrombocytopenia, autoimmune hemolytic anemia, or Evans syndrome. The study follows patients from diagnosis with repeated data collection and up to 19 years of follow-up. It supports research into long-term health, genetic causes, and the benefit–risk balance of treatments.

What it is studying. The study is collecting long-term clinical, treatment and safety data to describe health outcomes over time, identify genetic and pathophysiologic contexts underlying pediatric-onset autoimmune cytopenias, and study the benefit–risk balance of treatments including targeted therapies.

What the researchers hope to learn. Scientific goals: describe long-term health and clinical events in people with pediatric-onset autoimmune cytopenias; identify immunopathological manifestations (for example systemic lupus erythematosus, primary immunodeficiency) and heterogeneous genetic/pathophysiologic contexts; record treatment lines, adverse drug reactions, and other events (cancer, infection, thrombosis, death); and provide data to study the benefit–risk balance of therapies, including targeted treatments.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

From 2004, OBS'CEREVANCE is a national real-world prospective clinical cohort of patients with auto-immune cytopenia of pediatric-onset : Immune thrombocytopenia (ITP), Autoimmune Hemolytic anemia (AIHA), or Evans syndrome (all bi or tri cytopenias). Thanks to the collaboration of the 30 French pediatric hematologic centers, this cohort supports all of the Rare Disease Centre CEREVANCE (Centre de Référence National des Cytopénies Auto-Immunes de l'Enfant) missions for care, education and research. Specifically, this original unbiased database allows to describe the long-term health of adult patients, to identify the heterogenous genetic underlying pathophysiologic contexts, and to study the benefit-risk balance of treatments, including the growing development of targeted therapies.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • data collection

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Diagnosis of ITP, AIHA, Evans Syndrome
  • Onset before the age of 18

Exclusion criteria

  • Opposition of legal representative or to data collection

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Immune thrombocytopenic purpura (ITP) and autoimmune hemolytic anemia (AHAI) are rare childhood diseases that involve autoimmune destruction of platelets and erythrocytes respectively. They may be associated with an even rarer entity, Evans syndrome (ES). These three conditions are referred to as autoimmune cytopenias (AIC). In association with CAI, patients may present with various immunopathological (IM) manifestations such as lymphoproliferation, autoimmune autoimmune/autoinflammatory organ diseases that may be absent at the time of at the time of diagnosis of CAI and develop during follow-up. Since 2004, the CEREVANCE reference center for childhood autoimmune CEREVANCE has been coordinating a national prospective cohort of patients with pediatric-onset CAI including over 1900 patients (data 05/2023). Thanks to the collaboration of the 30 French pediatric hematologic centers, this cohort supports all of the Rare Disease Centre CEREVANCE (Centre de Référence National des Cytopénies Auto-Immunes de l'Enfant) missions for care, education and research. Specifically, this original unbiased database allows to describe the long-term health of adult patients, to identify the heterogenous genetic underlying pathophysiologic contexts, and to study the benefit-risk balance of treatments, including the growing development of targeted therapies.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants have their medical information collected prospectively and entered into the national cohort database. Investigators record diagnoses, treatments (including lines of therapy), adverse drug reactions, and events of interest (for example cancer, infection, thrombosis, death) at baseline and then every 6 months, with follow-up possible for up to 19 years. Clinical care follows national pediatric guidelines; the registry record does not list any additional invasive research procedures beyond routine care. The record does not detail specific extra tests or sample collections for research.

How the study is structured. A prospective observational registry (cohort) run by pediatric hematology centers. Centers enter patients at diagnosis and collect clinical data over time; the study does not assign treatments. Data are recorded at baseline and repeatedly during follow-up (registry follow-up up to 19 years).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Evans syndrome

This trial is also listed on this site under autoimmune hemolytic anemia.

Clinical trials7 trials listed for Evans syndromeEvery trial the registry lists for Evans syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Evans syndrome researchLatest monthly update: September 2026. Includes: Genetic immune disorders. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 1, 2010
Primary completion
Dec 31, 2029 (estimated)
Study completion
Dec 31, 2029 (estimated)
Target enrollment
3500 participants (estimated)
Last updated on registry
Jul 10, 2023
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University Hospital, Bordeaux

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (9)

  • CHU Amiens Picardie Service d' Onco-Immuno-Hématologie PédiatriqueRecruiting

    Amiens · France

  • CHU d'Angers Unité d'Hémato-Oncologie PédiatriqueRecruiting

    Angers · France

    • Isabelle PELLIER
    • ispellier@chu-angers.fr
  • BESANCON CHU de Besançon Hôpital Jean MINJOZ Unité d'Hémato-Oncologie Pédiatrique, Pédiatrie 1Recruiting

    Besançon · France

    • Nathalie CHEIKH
    • ncheikh@chu-besancon.fr
  • CHU de Bordeaux - Unité d'Hématologie et d'Oncologie pédiatriqueRecruiting

    Bordeaux · France

  • CHU BREST Hôpital Morvan Unité d'Onco-HématologieRecruiting

    Brest · France

  • CHU de Caen Unité d'Onco-HématologieRecruiting

    Caen · France

  • CHU de Clermont FerrandRecruiting

    Clermont-Ferrand · France

  • APHP Hôpital Bicêtre Service de Pédiatrie généraleRecruiting

    Paris · France

  • CH de Cornouaille Service de PédiatrieRecruiting

    Quimper · France

Terms used on this page · explanations by MedicalUpdates.ai

cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
legal representative
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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