Epidemiological Data on Mast Cell Pathologies in France

Mast Cell Disorder Clinical Trial

— DATAMAST  

Official title:

Epidemiological Data on Mast Cell Pathologies in France

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186856
• Other study ID #: HJ-22-DATAMAST
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2038

Study information

• Verified date: April 2024
• Source: Imagine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13000
• Est. completion date: December 31, 2038
• Est. primary completion date: December 31, 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Children from birth and adults of any age

2. 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 BMACS (1 to 2 criteria according to WHO 2016 classification).

3. Affiliation to a social security

4. 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.

Related Conditions & MeSH terms

• Mast Cell Disorder

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants malades	Paris	Ile-de-France
France	Pr Olivier Hermine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Imagine Institute

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidemiology of mast cell disorders in France assessed by statistics on the prevalence on the various types of mast cell disorders		Data 2010 - 2038
Primary	Epidemiology of mast cell disorders in France assessed by statistics on the incidence on the various types of mast cell disorders		Data 2010 - 2038
Secondary	Patient characteristics	age, gender, personal and family medical history	Data 2010 - 2038
Secondary	Characteristics of mast cell disease assessed by type of disease		Data 2010 - 2038
Secondary	Characteristics of mast cell disease assessed by diagnostic criteria		Data 2010 - 2038
Secondary	Characteristics of mast cell disease assessed by symptoms of disease		Data 2010 - 2038
Secondary	Evolution of mast cell disease assessed by progression of skin lesions		Data 2010 - 2038
Secondary	Evolution of mast cell disease assessed by progression to aggressive form		Data 2010 - 2038
Secondary	Evolution of mast cell disease assessed by associated hemopathy		Data 2010 - 2038
Secondary	Evolution of mast cell disease assessed by appearance of new symptoms		Data 2010 - 2038
Secondary	Patient follow-up assessed by occurrence of other medical events in the patient		Data 2010 - 2038
Secondary	Patient follow-up assessed by overall survival		Data 2010 - 2038
Secondary	Types of treatment used on mastocytosis and any associated hemopathy		Data 2010 - 2038
Secondary	Tolerance of treatment used on mastocytosis and any associated hemopathy		Data 2010 - 2038
Secondary	Efficacy of treatment used on mastocytosis and any associated hemopathy		Data 2010 - 2038