Mastocytosis From Pediatric Age to Adulthood: Local Registry of Cutaneous and Systemic Mastocytosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Prevalence of the systemic disease variant in the examined population
研究概览
简要总结
Given the renewed focus on mastocytosis (recognized in Italy as a rare disease since 2018) and emerging clinical and immunogenetic knowledge, and considering the rarity of the disease and limited understanding of its progression, this observational study aims to analyze epidemiological, clinical, genetic, immunohistochemical, and laboratory characteristics of patients with mastocytosis. This will help expand knowledge about the disease and identify prognostic variables useful in developing a personalized therapeutic approach.
This registry aims to collect retrospective and prospective data on patients with cutaneous and systemic mastocytosis attending the Dermatology Unit at the IRCCS Fondazione Policlinico San Matteo.
This is a single-center longitudinal hospital registry including patients with cutaneous and systemic mastocytosis, collected retrospectively and prospectively to assess the clinical, serological, hematological, and molecular characteristics of patients with cutaneous and systemic mastocytosis and their correlation with specific outcomes such as disease variant (cutaneous or systemic), extent of skin involvement, and survival rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Prevalence of the systemic disease variant in the examined population
时间窗: January 2034
The prevalence and the 95% exact binomial confidence interval will be presented
次要结局
- Association between clinical, serological, hematological, and molecular characteristics and the disease variant (cutaneous or systemic)(January 2034)
- Survival rate in relation to the disease variant (cutaneous or systemic)(January 2034)
- Association between family history and age of disease onset(January 2034)
- Association between c-KIT mutation in blood and clinical characteristics of the patient(January 2034)
- Evaluation of dermatoscopic characteristics in relation to the clinical presentation of the disease and the patient's age(January 2034)
研究者
Valeria Brazzelli
MD
Fondazione IRCCS Policlinico San Matteo di Pavia