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Assessment of Burden Disease in Patients With Mast Cell Disorders

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04615663
Acronym
MCD&BuDi
Enrollment
200
Registered
2020-11-04
Start date
2020-01-28
Completion date
2022-09-15
Last updated
2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous, Mastocytosis

Keywords

Burden, quality of life, mast cell disease, work impairment

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.

Interventions

BEHAVIORALScore SMI

the investigator will complete the SMI score

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Months to 65 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life of mast cell disorder patientsBaselineQuality of life is evaluated with the WHOQOL-bref questionary. This validated questionnaire in French assesses six dimensions of quality of life.

Secondary

MeasureTime frameDescription
Mast cell disorder patient's life quality6 monthsQuality of life is evaluated with the WHOQOL-bref.
Mast cell disorder patient's quality of life12 monthsQuality of life is evaluated with the WHOQOL-bref.

Countries

France

Contacts

Primary ContactLIVIDEANU Cristina, MD
livideanu.c@chu-toulouse.fr0567778135
Backup ContactNEGRETTO Mathilde
negretto.m@chu-toulouse.fr05 67 77 81 68

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026