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Mast Cell DisorderDATAMASTNCT06186856

Epidemiological Data on Mast Cell Pathologies in France

An observational study of Mast Cell Disorder, run by Imagine Institute at 21 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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)… Read more about this study

Who is it for?
Any age
Conditions the study is for
Mast Cell Disorder
How many people
13,000 participants
Where
21 sitesFrance
Study dates
1 Nov 2024to 31 Dec 2038
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patient with mast cell diseases, managed in France in a rare disease reference center CEREMAST. 13000 pateints estimated.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Julien Rossignol, Dr contact

+33 (0)1 44 49 40 00

julien.rossignol@aphp.fr

21 sites in 1 country

France21 sites, 21 recruiting

  • CHU AMIENS site sud

    Amiens

    Clément GOURGUECHON, Dr, +33 (0)3 22 45 59 14, Gourguechon.Clement@chu-amiens.fr

    Clément GOURGUECHON, Dr

    Recruiting

  • Chu Angers

    Angers, 49100

    Christian Lavigne, Dr, +33 (0)2 41 35 36 37, ChLavigne@chu-angers.fr

    Christian Lavigne, Dr

    Recruiting

  • Chu - Besancon

    Besançon, 25000

    Florence CASTELAIN, Dr, +33 (0)3 81 21 80 97, fcastelain@chu-besancon.fr

    Florence CASTELAIN, Dr

    Recruiting

  • Chu - Caen

    Caen, 14033

    Gandhi DAMAJ, Pr, +33 (0)2 31 27 21 07, damaj-gl@chu-caen.fr

    Yann OLLIVIER, Dr, ollivier-y@chu-caen.fr

    Recruiting

  • Chu - Clermont Ferrand

    Clermont-Ferrand

    Olivier TOURNILHAC, Pr, +33 (0)4 73 75 00 74, otournilhac@chu-clermontferrand.fr

    Olivier TOURNILHAC, Pr

    Recruiting

  • CHU Grenoble

    Grenoble, 38700

    Laurence BOUILLET, Pr, lbouillet@chu-grenoble.fr

    Laurence BOUILLET, Pr

    Recruiting

  • Chru Lille

    Lille, 59037

    David LAUNAY, Pr, +33 (0)3 20 44 42 96, david.launay@chru-lille.fr

    David LAUNAY, Pr

    Recruiting

  • Chu - Limoges

    Limoges, 87000

    Marie-Pierre GOURIN, Dr, +33 (0)5 55 05 66 42, marie-pierre.gourin@chu-limoges.fr

    Marie-Pierre GOURIN, Dr

    Recruiting

  • Hospices Civils de Lyon

    Lyon

    Maël Heiblig, Dr, mael.heiblig@chu-lyon.fr

    Maël Heiblig, Dr

    Recruiting

  • Chu - La Timone - Marseille

    Marseille, 13005

    Caroline GAUDY, Pr, +33 (0)1 43 27 01 56, Caroline.GAUDY@ap-hm.fr

    Caroline GAUDY, Pr

    Recruiting

  • CHU de Montpellier

    Montpellier, 34090

    Philippe GUILPAIN, Pr, P-guilpain@chu-montpellier.fr

    Philippe GUILPAIN, Pr

    Recruiting

  • CHU de NANCY

    Nancy, 54035

    Roland JAUSSAUD, Pr, +33 (0)3 83 15 41 43., R.JAUSSAUD@chru-nancy.fr

    Roland JAUSSAUD, Pr

    Recruiting

  • Chu - Nantes

    Nantes, 44000

    Antoine NEEL, Pr, +33 (0)2 40 08 33 55, antoine.neel@chu-nantes.fr

    Antoine NEEL, Pr

    Recruiting

  • Hôpital Universitaire Pitié Salpetrière

    Paris, 75013

    Stephane Barete, Dr, +33 (0)1 42 16 10 58, stephane.barete@aphp.fr

    Stephane Barete, Dr

    Recruiting

  • Hôpital Necker-Enfants malades

    Paris, 75015

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

    Hassiba Bouktit, +33 (0)1 44 49 53 31, hassiba.bouktit@aphp.fr

    Recruiting

  • CHU - Poitiers

    Poitiers

    Ewa Hainaut, Dr, ewa.hainaut@chu-poitiers.fr

    Ewa Hainaut, Dr

    Recruiting

  • Chu - Rennes

    Rennes, 35000

    Edwige LE MOUEL, Dr, +33 (0)2 99 26 71 28, edwige.le.mouel@chu-rennes.fr

    Edwige LE MOUEL, Dr

    Recruiting

  • CHU Réunion sud - Saint Pierre

    Saint-Pierre, 97448

    Quentin CABRERA, Dr, 262 (0)262 35 91 78, quentin.cabrera@chu-reunion.fr

    Quentin CABRERA, Dr

    Recruiting

  • Chru - Strasbourg

    Strasbourg, 67200

    Rose-Marie JAVIER, Dr, +33 (0)3 88 11 67 68, rose-marie.javier@chru-strasbourg.fr

    Rose-Marie JAVIER, Dr

    Recruiting

  • CHU Purpan

    Toulouse, 40031

    Cristina LIVIDEANU, Dr, livideanu.c@chu-toulouse.fr

    Cristina LIVIDEANU, Dr

    Recruiting

  • CHU de TOURS

    Tours, 37000

    Cyrille HOARAU, Dr, hoarau_c@med.univ-tours.fr

    Cyrille HOARAU, Dr

    Recruiting

Other trials in France

About this study

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.
Read more

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.

Keywords
Mast Cell Disease, Mastocytosis, mast cell-associated diseases
Medical subject headings
Mastocytosis, Mast Cell Activation Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06186856
Study groupRoleWhat they receive
PatientsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Epidemiology of mast cell disorders in France assessed by statistics on the prevalence on the various types of mast cell disorders

    Measured: 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

    Measured: Data 2010 - 2038

Secondary outcomes (13)

  1. Patient characteristics

    age, gender, personal and family medical history

    Measured: Data 2010 - 2038

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

    Measured: Data 2010 - 2038

  3. Characteristics of mast cell disease assessed by diagnostic criteria

    Measured: Data 2010 - 2038

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

    Measured: Data 2010 - 2038

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

    Measured: Data 2010 - 2038

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

    Measured: Data 2010 - 2038

  7. Evolution of mast cell disease assessed by associated hemopathy

    Measured: Data 2010 - 2038

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

    Measured: Data 2010 - 2038

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

    Measured: Data 2010 - 2038

  10. Patient follow-up assessed by overall survival

    Measured: Data 2010 - 2038

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

    Measured: Data 2010 - 2038

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

    Measured: Data 2010 - 2038

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

    Measured: Data 2010 - 2038

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2024
  2. Study start1 Nov 2024
  3. Primary completion31 Dec 2038 (estimated)
  4. Study completion31 Dec 2038 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
13,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06186856
Sponsor's protocol ID
HJ22-DATAMAST
Acronym
DATAMAST
Status last verified
Apr 2026
First submitted
21 Nov 2023
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Mast Cell Disorder, run by Imagine Institute at 21 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julien Rossignol, Dr (+33 (0)1 44 49 40 00, julien.rossignol@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06186856.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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