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Recruiting NCT06186856

Epidemiological Data on Mast Cell Pathologies in France

— Observational Mast Cell Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Mast Cell Disorder. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Mast cell disorders constitute a heterogeneous group of diseases, including : * mastocytosis, i.e. cutaneous, indolent and severe forms of the disease, such as aggressive mastocytosis and mast cell leukemia) ; * mast cell-associated diseases such as mast cell activation syndrome (idiopathic, secondary or clonal), affecting both children and adults. No epidemiological data are currently available in France. In France, medical care of mast cell disorders is mainly provided by a rare disease network (CEREMAST), whose CRMR is located at the Necker Enfants Malades hospital in Paris. A total of 20 centers are located throughout France. Our aim is to use this network to study patients suffering from these diseases. The overall aim of the study is to improve the understanding, diagnosis, prognosis, recognition and management of patients with mastocytosis.

Primary outcome measures

  • Epidemiology of mast cell disorders in France assessed by statistics on the prevalence on the various types of mast cell disorders [Time frame: Data 2010 - 2038]
  • Epidemiology of mast cell disorders in France assessed by statistics on the incidence on the various types of mast cell disorders [Time frame: Data 2010 - 2038]
Secondary outcome measures (12)
  • Patient characteristics [Time frame: Data 2010 - 2038]
  • Characteristics of mast cell disease assessed by type of disease [Time frame: Data 2010 - 2038]
  • Characteristics of mast cell disease assessed by diagnostic criteria [Time frame: Data 2010 - 2038]
  • Characteristics of mast cell disease assessed by symptoms of disease [Time frame: Data 2010 - 2038]
  • Evolution of mast cell disease assessed by progression of skin lesions [Time frame: Data 2010 - 2038]
  • Evolution of mast cell disease assessed by progression to aggressive form [Time frame: Data 2010 - 2038]
  • Evolution of mast cell disease assessed by associated hemopathy [Time frame: Data 2010 - 2038]
  • Evolution of mast cell disease assessed by appearance of new symptoms [Time frame: Data 2010 - 2038]
  • Patient follow-up assessed by occurrence of other medical events in the patient [Time frame: Data 2010 - 2038]
  • Patient follow-up assessed by overall survival [Time frame: Data 2010 - 2038]
  • Types of treatment used on mastocytosis and any associated hemopathy [Time frame: Data 2010 - 2038]
  • Tolerance of treatment used on mastocytosis and any associated hemopathy [Time frame: Data 2010 - 2038]

Eligibility criteria

Inclusion criteria

  • Children from birth and adults of any age
  • With one of the following mast cell diseases:
  • Mastocytoses (cutaneous, systemic and sarcomas) Defined according to the WHO 2016 classification
  • Mast cell activation syndromes (idiopathic, secondary and clonal)
  • Other mast cell activation disorders (MCAD-NOS), Defined according to the Vienna classification
  • Pre-mastocytosis or MMC (1 to 2 criteria according to WHO 2016 classification).
  • Managed in France in a rare disease reference, constitutive or competence center (CEREMAST) with DGOS labelization.

Exclusion criteria

1\. Opposition of the patient or his/her parents to participation in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 21 centers
  • CHU AMIENS site sud — Amiens
  • Chu Angers — Angers
  • Chu - Besancon — Besançon
  • Chu - Caen — Caen
  • Chu - Clermont Ferrand — Clermont-Ferrand
  • CHU Grenoble — Grenoble
  • Chru Lille — Lille
  • Chu - Limoges — Limoges
  • … and 13 more centers

Identifiers

NCT: NCT06186856 · HJ22-DATAMAST

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗