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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

From the registry’s dates

  • Started Nov 2024; still recruiting 2 years later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
13,000
Sex
All
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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.

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Conditions studied

  • Mast Cell Disorder

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Keywords

  • Mast Cell Disease
  • Mastocytosis
  • mast cell-associated diseases
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In context

Mastocytosis

49 studies on the registry are indexed under Mastocytosis; 14 are open to participants now.

This study's planned enrollment of 13,000 is above the median of 200 across 25 observational studies indexed under Mastocytosis.

Browse Mastocytosis studies →

Lead sponsor

Imagine Institute is the lead sponsor of 31 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.

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Study design

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

Groups and cohorts

  • Patients
06

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

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Study locations

21 of 21 sites recruiting
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2024 (actual). Primary completion is estimated for Dec 2038, 169 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2023
First posted
Jan 2, 2024
StartActual
Nov 1, 2024
Primary completionEst.
Dec 31, 2038
CompletionEst.
Dec 31, 2038
Last update
Apr 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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