Epidemiological Data on Mast Cell Pathologies in France (DATAMAST)

April 21, 2026 updated by: Imagine Institute

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

13000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France
        • Recruiting
        • CHU AMIENS site sud
        • Contact:
        • Principal Investigator:
          • Clément GOURGUECHON, Dr
      • Angers, France, 49100
        • Recruiting
        • CHU Angers
        • Contact:
        • Principal Investigator:
          • Christian Lavigne, Dr
      • Besançon, France, 25000
        • Recruiting
        • Chu - Besancon
        • Principal Investigator:
          • Florence CASTELAIN, Dr
        • Contact:
      • Caen, France, 14033
        • Recruiting
        • Chu - Caen
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gandhi DAMAJ, Pr
        • Sub-Investigator:
          • Yann OLLIVIER, Dr
      • Clermont-Ferrand, France
        • Recruiting
        • Chu - Clermont Ferrand
        • Contact:
        • Principal Investigator:
          • Olivier TOURNILHAC, Pr
      • Grenoble, France, 38700
        • Recruiting
        • CHU Grenoble
        • Contact:
        • Principal Investigator:
          • Laurence BOUILLET, Pr
      • Lille, France, 59037
        • Recruiting
        • CHRU Lille
        • Contact:
        • Principal Investigator:
          • David LAUNAY, Pr
      • Limoges, France, 87000
        • Recruiting
        • Chu - Limoges
        • Principal Investigator:
          • Marie-Pierre GOURIN, Dr
        • Contact:
      • Lyon, France
        • Recruiting
        • Hospices Civils de Lyon
        • Contact:
        • Principal Investigator:
          • Maël Heiblig, Dr
      • Marseille, France, 13005
        • Recruiting
        • Chu - La Timone - Marseille
        • Contact:
        • Principal Investigator:
          • Caroline GAUDY, Pr
      • Montpellier, France, 34090
        • Recruiting
        • CHU de Montpellier
        • Contact:
        • Principal Investigator:
          • Philippe GUILPAIN, Pr
      • Nancy, France, 54035
        • Recruiting
        • CHU de Nancy
        • Principal Investigator:
          • Roland JAUSSAUD, Pr
        • Contact:
      • Nantes, France, 44000
        • Recruiting
        • Chu - Nantes
        • Contact:
        • Principal Investigator:
          • Antoine NEEL, Pr
      • Paris, France, 75015
        • Recruiting
        • Hôpital Necker-Enfants Malades
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Julien Rossignol, Dr
        • Principal Investigator:
          • Olivier Hermine, Pr
      • Paris, France, 75013
        • Recruiting
        • Hôpital Universitaire Pitié Salpêtrière
        • Contact:
        • Principal Investigator:
          • Stephane Barete, Dr
      • Poitiers, France
      • Rennes, France, 35000
        • Recruiting
        • Chu - Rennes
        • Contact:
        • Principal Investigator:
          • Edwige LE MOUEL, Dr
      • Saint-Pierre, France, 97448
        • Recruiting
        • CHU Réunion sud - Saint Pierre
        • Contact:
        • Principal Investigator:
          • Quentin CABRERA, Dr
      • Strasbourg, France, 67200
        • Recruiting
        • Chru - Strasbourg
        • Contact:
        • Principal Investigator:
          • Rose-Marie JAVIER, Dr
      • Toulouse, France, 40031
        • Recruiting
        • CHU Purpan
        • Contact:
        • Principal Investigator:
          • Cristina LIVIDEANU, Dr
      • Tours, France, 37000
        • Recruiting
        • CHU de Tours
        • Contact:
        • Principal Investigator:
          • Cyrille HOARAU, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with mast cell diseases, managed in France in a rare disease reference center CEREMAST.

13000 pateints estimated.

Description

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 MMC (1 to 2 criteria according to WHO 2016 classification).
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Data 2010 - 2038

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient characteristics
Time Frame: Data 2010 - 2038
age, gender, personal and family medical history
Data 2010 - 2038
Characteristics of mast cell disease assessed by type of disease
Time Frame: Data 2010 - 2038
Data 2010 - 2038
Characteristics of mast cell disease assessed by diagnostic criteria
Time Frame: Data 2010 - 2038
Data 2010 - 2038
Characteristics of mast cell disease assessed by symptoms of disease
Time Frame: Data 2010 - 2038
Data 2010 - 2038
Evolution of mast cell disease assessed by progression of skin lesions
Time Frame: Data 2010 - 2038
Data 2010 - 2038
Evolution of mast cell disease assessed by progression to aggressive form
Time Frame: Data 2010 - 2038
Data 2010 - 2038
Evolution of mast cell disease assessed by associated hemopathy
Time Frame: Data 2010 - 2038
Data 2010 - 2038
Evolution of mast cell disease assessed by appearance of new symptoms
Time Frame: Data 2010 - 2038
Data 2010 - 2038
Patient follow-up assessed by occurrence of other medical events in the patient
Time Frame: Data 2010 - 2038
Data 2010 - 2038
Patient follow-up assessed by overall survival
Time Frame: Data 2010 - 2038
Data 2010 - 2038
Types of treatment used on mastocytosis and any associated hemopathy
Time Frame: Data 2010 - 2038
Data 2010 - 2038
Tolerance of treatment used on mastocytosis and any associated hemopathy
Time Frame: Data 2010 - 2038
Data 2010 - 2038
Efficacy of treatment used on mastocytosis and any associated hemopathy
Time Frame: Data 2010 - 2038
Data 2010 - 2038

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imagine Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

December 31, 2038

Study Completion (Estimated)

December 31, 2038

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Actual)

January 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HJ22-DATAMAST

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mast Cell Disorder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe