Assessment of Burden Disease in Patients With Mast Cell Disorders

• Conditions: Cutaneous; Mastocytosis
• Interventions: Behavioral: Score SMI

• Registration Number: NCT04615663
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-01-28
• Study First Submitted: 2020-06-16
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-03
• Last Update Submitted: 2020-11-03
• Study First Posted: 2020-11-04
• Last Update Posted: 2020-11-04
• Primary Completion: 2021-01-28
• Study Completion: 2022-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
face-to-face patients	Score SMI	During this visit, the investigator will complete the SMI score.

Primary Outcome Measures

Name	Time	Method
Quality of life of mast cell disorder patients	Baseline	Quality of life is evaluated with the WHOQOL-bref questionary. This validated questionnaire in French assesses six dimensions of quality of life.

Secondary Outcome Measures

Name	Time	Method
Mast cell disorder patient's life quality	6 months	Quality of life is evaluated with the WHOQOL-bref.
Mast cell disorder patient's quality of life	12 months	Quality of life is evaluated with the WHOQOL-bref.

Trial Locations

Locations (1)

Cristina BULAI LIVIDEANU; 🇫🇷 Toulouse, France