Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05937828

OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia

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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Opposition of legal representative or to data collection

Treatment and study plan

Data Collection

Other

description of the long-term health of adult patients, identification of the heterogenous genetic underlying pathophysiologic contexts, study of the benefit-risk balance of treatments, including the growing development of targeted therapies.

Primary outcomes

  1. AIC context

    Time frame: Baseline

    Number of patients with immunopathological manifestations (IM), systemic erythematosus lupus (SLE), primary immunodeficiency (PID).

Secondary outcomes

  1. Treatment lines

    Time frame: every 6 months after baseline up to 19 years

    Percentage of patients with each treatment by line of treatments

  2. Adverse drug reactions

    Time frame: every 6 months after baseline up to 19 years

    Percentage of patients with adverse drug reaction reported by investigators

  3. Events

    Time frame: every 6 months after baseline up to 19 years

    Percentage of patients with other events of interest like cancer, infection, thrombosis, death

  4. AIC context

    Time frame: every 6 months after baseline up to 19 years

    Number of patients with immunopathological manifestations (IM), systemic erythematosus lupus (SLE), primary immunodeficiency (PID).

Study contacts

Contact information is provided by the study sponsor or research team.

Aurore Capelli

CONTACT

[email protected]

0557820877

Nathalie ALADJIDI, MD

CONTACT

[email protected]

+33 557820261

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: OBS'CEREVANCE

Important dates

Study start
2010
Primary completion
2029
Study completion
2029
First posted
Jul 10, 2023
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.