OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorUniversity Hospital, Bordeaux
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of ITP, AIHA, Evans Syndrome
Onset before the age of 18
Disqualifiers
Opposition of legal representative or to data collection
Trial population
Each of the 30 hemato-immunologic pediatric unit in France guaranties the prospective in real time inclusion in the cohort of all the children diagnosed in their unit, before 18 years old, with ITP, AIHA or Evans syndrome diagnosis, whatever the date of diagnosis at the date of inclusion. This observational cohort is prospective from the day of initial diagnosis of the auto-immune cytopenia The pediatricians from this rare disease CEREVANCE national network follow national guidelines for evaluation and treatment (PNDS 2009, 2017)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
data collection
Other interventiondescription 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.
Treatment groups
3,500 Participants
are divided into 3 treatment groupsGroup A: Immune thrombocytopenia (ITP)1 intervention
Group B: Autoimmune Hemolytic anemia (AIHA)1 intervention
Group C: Evans syndrome (all bi or tri cytopenias)1 intervention
Trial outcomes
Primary outcomes
1
AIC context
Number of patients with immunopathological manifestations (IM), systemic erythematosus lupus (SLE), primary immunodeficiency (PID).
Time frame
BaselineSecondary outcomes
1
Treatment lines
Percentage of patients with each treatment by line of treatments
Time frame
every 6 months after baseline up to 19 years2
Adverse drug reactions
Percentage of patients with adverse drug reaction reported by investigators
Time frame
every 6 months after baseline up to 19 years3
Events
Percentage of patients with other events of interest like cancer, infection, thrombosis, death
Time frame
every 6 months after baseline up to 19 years4
AIC context
Number of patients with immunopathological manifestations (IM), systemic erythematosus lupus (SLE), primary immunodeficiency (PID).
Time frame
every 6 months after baseline up to 19 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov