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RecruitingNCT06186856DATAMASTUpdated Apr 22, 2026

Epidemiological Data on Mast Cell Pathologies in France

An observational study in Mast Cell Disorder, sponsored by Imagine Institute. Recruiting at 21 sites in France. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Imagine Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
13,000
Sex
All
01

Study 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.

02

Conditions studied

  • Mast Cell Disorder

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Keywords

  • Mast Cell Disease
  • Mastocytosis
  • mast cell-associated diseases
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

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

Exclusion Criteria:

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

04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
13,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients
05

What researchers measure

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

    age, gender, personal and family medical history

    Time frame: Data 2010 - 2038

  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

06

Study locations

21 of 21 sites recruiting
  • CHU AMIENS site sud
    Amiens, France
    Recruiting
  • Chu Angers
    Angers, 49100, France
    • Christian Lavigne, Dr · Contact · ChLavigne@chu-angers.fr · +33 (0)2 41 35 36 37
    • Christian Lavigne, Dr · Principal investigator
    Recruiting
  • Chu - Besancon
    Besançon, 25000, France
    • Florence CASTELAIN, Dr · Contact · fcastelain@chu-besancon.fr · +33 (0)3 81 21 80 97
    • Florence CASTELAIN, Dr · Principal investigator
    Recruiting
  • Chu - Caen
    Caen, 14033, France
    Recruiting
  • Chu - Clermont Ferrand
    Clermont-Ferrand, France
    Recruiting
  • CHU Grenoble
    Grenoble, 38700, France
    Recruiting
  • Chru Lille
    Lille, 59037, France
    Recruiting
  • Chu - Limoges
    Limoges, 87000, France
    Recruiting
  • Hospices Civils de Lyon
    Lyon, France
    Recruiting
  • Chu - La Timone - Marseille
    Marseille, 13005, France
    • Caroline GAUDY, Pr · Contact · Caroline.GAUDY@ap-hm.fr · +33 (0)1 43 27 01 56
    • Caroline GAUDY, Pr · Principal investigator
    Recruiting
  • CHU de Montpellier
    Montpellier, 34090, France
    Recruiting
  • CHU de NANCY
    Nancy, 54035, France
    • Roland JAUSSAUD, Pr · Contact · R.JAUSSAUD@chru-nancy.fr · +33 (0)3 83 15 41 43.
    • Roland JAUSSAUD, Pr · Principal investigator
    Recruiting
  • Chu - Nantes
    Nantes, 44000, France
    Recruiting
  • Hôpital Universitaire Pitié Salpetrière
    Paris, 75013, France
    • Stephane Barete, Dr · Contact · stephane.barete@aphp.fr · +33 (0)1 42 16 10 58
    • Stephane Barete, Dr · Principal investigator
    Recruiting
  • Hôpital Necker-Enfants malades
    Paris, 75015, France
    • Julien Rossignol, Dr · Contact · julien.rossignol@aphp.fr · +33 (0)1 44 49 40 00
    • Hassiba Bouktit · Contact · hassiba.bouktit@aphp.fr · +33 (0)1 44 49 53 31
    • Julien Rossignol, Dr · Sub investigator
    • Olivier Hermine, Pr · Principal investigator
    Recruiting
  • CHU - Poitiers
    Poitiers, France
    Recruiting
  • Chu - Rennes
    Rennes, 35000, France
    Recruiting
  • CHU Réunion sud - Saint Pierre
    Saint-Pierre, 97448, France
    Recruiting
  • Chru - Strasbourg
    Strasbourg, 67200, France
    Recruiting
  • CHU Purpan
    Toulouse, 40031, France
    Recruiting
  • CHU de TOURS
    Tours, 37000, France
    Recruiting
07

Registry details

Key details

Study ID
NCT06186856
Lead sponsor
Imagine Institute
Responsible party
Sponsor
First posted
Jan 2, 2024
Start date
Nov 1, 2024
Primary completion
Dec 31, 2038 (estimated)
Completion
Dec 31, 2038 (estimated)
Last update
Apr 22, 2026

Study contacts

Julien Rossignol, Dr
Contact
julien.rossignol@aphp.fr
+33 (0)1 44 49 40 00

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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