Overview
This study will involve 27 centers in Italy. Since this is a multidisciplinary disease, participating centers may be from various medical areas (hematology, dermatology, allergy, etc.).
The study will last 10 years. The first patient is estimated to be enrolled in January 2021, while the last patient is expected to be completed in January 2031.
This is a retrospective and prospective registry. Since no intervention is foreseen, it can be considered an observational study.
The primary objective is to understand the clinical implications of mastocytosis, including the natural course of the disease, treatments and outcomes, variability in medical care, and disease burden.
Secondary objectives:
- To estimate the prevalence, incidence, and clinical course of mastocytosis
- To provide clinicians with prospective data to assist in the clinical management of individual patients
- To systematically collect data that can be integrated with data from other studies to support aggregate and comparative analyses.
Approximately 1,500 patients already treated at participating centers will be enrolled.
It is estimated that approximately 250-300 new patients will be included in the registry each year.
Patients ≥18 years of age and diagnosed with mastocytosis will be included in the study.
Each participant must be able to provide written informed consent to be enrolled.
There are no exclusion criteria. Variables to be collected. The study objectives will be assessed through data collection of the clinical and biological variables collected.
Eligibility
INCLUSION CRITERIA Age ≥ 18 years Diagnosis of mastocytosis according to current WHO criteria. Ability to give informed consent according to ICH/EU GCP, and national/local regulations.
EXCLUSION CRITERIA No exclusion criteria are expected.
