Trials / Unknown
UnknownNCT04615663
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- University Hospital, Toulouse · Academic / Other
- Sex
- All
- Age
- 18 Months – 65 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Score SMI | the investigator will complete the SMI score |
Timeline
- Start date
- 2020-01-28
- Primary completion
- 2021-01-28
- Completion
- 2022-09-15
- First posted
- 2020-11-04
- Last updated
- 2020-11-04
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04615663. Inclusion in this directory is not an endorsement.