Assessment of Burden Disease in Patients With Mast Cell Disorders (MCD&BuDi)

Toulouse University Hospital

Status: Unknown

Conditions: Mastocytosis; Cutaneous

Treatments: Behavioral: Score SMI

Study type: Observational

Funder types: Other

Identifiers

NCT04615663

RC31/19/0354

Details and patient eligibility

About

The symptoms caused by mast cell disorders can have a significant impact on the state of health of individuals, constituting a real burden for them, and consequently altering their quality of life. It therefore seems important to clarify the impact on the quality of life, on the psycho-affective sphere, on professional life and on the direct and indirect costs caused by the disease, as well as on the "patient's remaining burden". It seems possible by a longitudinal study (patient follow-up over 1 year).

Primary objective is Assessment of quality of life in adult patient with mast cell diseases at M0.

Full description

Mast cell activation symptoms are due to the release of mast cell mediators after uncontrolled activation of mast cells. The release by mast cells of mast cell mediators (tryptase, histamine, prostaglandins, serotonin) results in mast cell activation symptoms, found in mast cell activation syndrome but also in mastocytosis. These symptoms interested the skin, gastrointestinal gut, pulmonary, cardiovascular and neuropsychiatric organs, etc.

In mastocytosis, along with these symptoms of mast cell activation, the infiltration of different organs by abnormal mast cells produces many clinical signs related to the excess of monoclonal mast cells present in the organs.

According to our clinical experience, the impact of mast cell disorder on various dimensions of life, including economic life, seems important, but it has never accurately evaluated.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient (> 18 years old) with confirmed mast cell disorder according to international criteria
• Patient affiliated to social security regime

Exclusion criteria

• Patient under legal protection (guardianship, curators or court order)
• Patient does not speak French

Trial design

200 participants in 2 patient groups

face-to-face patients

Description:

During this visit, the investigator will complete the SMI score.

Treatment:

Behavioral: Score SMI

Email patients

Description:

this visit at M0 + 7d will correspond to the emailing of the Mc_QoL and Burden_MCD questionnaires completed by the patient.