NCT06186856

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,000

participants targeted

Target at P75+ for all trials

Timeline
154mo left

Started Nov 2024

Longer than P75 for all trials

Geographic Reach
1 country

21 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Nov 2024Dec 2038

First Submitted

Initial submission to the registry

November 21, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 2, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
14.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2038

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2038

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

14.2 years

First QC Date

November 21, 2023

Last Update Submit

April 21, 2026

Conditions

Mast Cell Disorder

Keywords

Mast Cell DiseaseMastocytosismast cell-associated diseases

Outcome Measures

Primary Outcomes (2)

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

    Data 2010 - 2038

  • 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 Outcomes (13)

  • Patient characteristics

    Data 2010 - 2038

  • Characteristics of mast cell disease assessed by type of disease

    Data 2010 - 2038

  • Characteristics of mast cell disease assessed by diagnostic criteria

    Data 2010 - 2038

  • Characteristics of mast cell disease assessed by symptoms of disease

    Data 2010 - 2038

  • Evolution of mast cell disease assessed by progression of skin lesions

    Data 2010 - 2038

  • +8 more secondary outcomes

Study Arms (1)

Patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

CHU AMIENS site sud

Amiens, France

RECRUITING

Chu Angers

Angers, 49100, France

RECRUITING

Chu - Besancon

Besançon, 25000, France

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

RECRUITING

CHU de Montpellier

Montpellier, 34090, France

RECRUITING

CHU de NANCY

Nancy, 54035, France

RECRUITING

Chu - Nantes

Nantes, 44000, France

RECRUITING

Hôpital Universitaire Pitié Salpetrière

Paris, 75013, France

RECRUITING

Hôpital Necker-Enfants malades

Paris, 75015, France

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

MeSH Terms

Conditions

MastocytosisMast Cell Activation Disorders

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsImmune System Diseases

Central Study Contacts

Julien Rossignol, Dr

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2023

First Posted

January 2, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

December 31, 2038

Study Completion (Estimated)

December 31, 2038

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

FR(21)