Assessment of Personal, Psychosocial, Work, and Economic Burden in Patients With Mast Cell Disorders,
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Quality of life of mast cell disorder patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Months 至 65 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (> 18 years old) with confirmed mast cell disorder according to international criteria
- •Patient affiliated to social security regime
排除标准
- •Patient under legal protection (guardianship, curators or court order)
- •Patient does not speak French
结局指标
主要结局
Quality of life of mast cell disorder patients
时间窗: Baseline
Quality of life is evaluated with the WHOQOL-bref questionary. This validated questionnaire in French assesses six dimensions of quality of life.
次要结局
- Mast cell disorder patient's life quality(6 months)
- Mast cell disorder patient's quality of life(12 months)