Mastocytosis From Pediatric Age to Adulthood: Local Registry of Cutaneous and Systemic Mastocytosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cutaneous Mastocytosis, Systemic Mastocytosis. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Prevalence of the systemic disease variant in the examined population [Time frame: January 2034]
Secondary outcome measures (5)
- Association between clinical, serological, hematological, and molecular characteristics and the disease variant (cutaneous or systemic) [Time frame: January 2034]
- Association between family history and age of disease onset [Time frame: January 2034]
- Survival rate in relation to the disease variant (cutaneous or systemic) [Time frame: January 2034]
- Association between c-KIT mutation in blood and clinical characteristics of the patient [Time frame: January 2034]
- Evaluation of dermatoscopic characteristics in relation to the clinical presentation of the disease and the patient's age [Time frame: January 2034]
Eligibility criteria
Inclusion criteria
\- Cutaneous or systemic mastocytosis diagnosys attending the Dermatology Outpatient Clinics of the UOC Dermatology Unit Fondazione IRCCS Policlinico San Matteo
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- SC Dermatologia, Fondazione IRCCS Policlinico San Matteo — Pavia
Identifiers
NCT: NCT07142473 · MaRe