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NCT Number: NCT06186856

Epidemiological Data on Mast Cell Pathologies in France

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.

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Key information

Conditions

Mast Cell Disorder Immune System Diseases Mast Cell Activation Disorders Mastocytosis Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU AMIENS site sud, Amiens, France

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Who can participate

Healthy volunteers accepted: No

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

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

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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 outcomes

  1. Patient characteristics

    Time frame: Data 2010 - 2038

    age, gender, personal and family medical history

  2. Characteristics of mast cell disease assessed by type of disease

    Time frame: Data 2010 - 2038

  3. Characteristics of mast cell disease assessed by diagnostic criteria

    Time frame: Data 2010 - 2038

  4. Characteristics of mast cell disease assessed by symptoms of disease

    Time frame: Data 2010 - 2038

  5. Evolution of mast cell disease assessed by progression of skin lesions

    Time frame: Data 2010 - 2038

  6. Evolution of mast cell disease assessed by progression to aggressive form

    Time frame: Data 2010 - 2038

  7. Evolution of mast cell disease assessed by associated hemopathy

    Time frame: Data 2010 - 2038

  8. Evolution of mast cell disease assessed by appearance of new symptoms

    Time frame: Data 2010 - 2038

  9. Patient follow-up assessed by occurrence of other medical events in the patient

    Time frame: Data 2010 - 2038

  10. Patient follow-up assessed by overall survival

    Time frame: Data 2010 - 2038

  11. Types of treatment used on mastocytosis and any associated hemopathy

    Time frame: Data 2010 - 2038

  12. Tolerance of treatment used on mastocytosis and any associated hemopathy

    Time frame: Data 2010 - 2038

  13. Efficacy of treatment used on mastocytosis and any associated hemopathy

    Time frame: Data 2010 - 2038

Study contacts

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

Julien Rossignol, Dr

CONTACT

[email protected]

+33 (0)1 44 49 40 00

Sponsors and collaborators

Lead sponsor

Imagine Institute

Other

Registry information

Acronym: DATAMAST

Important dates

Study start
2024
Primary completion
2038
Study completion
2038
First posted
Jan 2, 2024
Registry last updated
Apr 22, 2026

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.

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