Assessment of Burden Disease in Patients With Mast Cell Disorders

Mastocytosis Clinical Trial

— MCD&BuDi  

Official title:

Assessment of Personal, Psychosocial, Work, and Economic Burden in Patients With Mast Cell Disorders,

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04615663
• Other study ID #: RC31/19/0354
• Status: Recruiting
• Start date: January 28, 2020
• Est. completion date: September 15, 2022

Study information

• Verified date: November 2020
• Source: University Hospital, Toulouse
• Contact: LIVIDEANU Cristina, MD
• Phone: 0567778135
• Email: livideanu.c[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 15, 2022
• Est. primary completion date: January 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 65 Months

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous
• Mastocytosis

Intervention

Behavioral:
• Score SMI
the investigator will complete the SMI score

Locations

Country	Name	City	State
France	Cristina BULAI LIVIDEANU	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life of mast cell disorder patients	Quality of life is evaluated with the WHOQOL-bref questionary. This validated questionnaire in French assesses six dimensions of quality of life.	Baseline
Secondary	Mast cell disorder patient's life quality	Quality of life is evaluated with the WHOQOL-bref.	6 months
Secondary	Mast cell disorder patient's quality of life	Quality of life is evaluated with the WHOQOL-bref.	12 months