Clinical trial · Observational
Mastocytosis From Pediatric Age to Adulthood: Local Registry of Cutaneous and Systemic Mastocytosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Mastocytosis | Cutaneous Mastocytosis | ONTOLOGY_EXACT | 0.98 |
| Systemic Mastocytosis | Systemic Mastocytosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- patients diagnosed with cutaneous or systemic mastocytosis
Primary outcomes (1)
- measure
- Prevalence of the systemic disease variant in the examined population
- timeFrame
- January 2034
- description
- The prevalence and the 95% exact binomial confidence interval will be presented
Secondary outcomes (5)
- measure
- Association between clinical, serological, hematological, and molecular characteristics and the disease variant (cutaneous or systemic)
- timeFrame
- January 2034
- description
- The association will be evaluated using a multivariate logistic model; the number of covariates will be limited by the number of systemic mastocytosis cases, maintaining a 1:10 ratio. The selection of covariates will be made a priori based on scientific knowledge. Odds ratios (OR) and their corresponding 95% confidence intervals (CI) will be reported. The model's discriminatory ability (area under the ROC curve) and its calibration (graphically) will be calculated
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
Show eligibility criteria text
Inclusion criteria: \- Cutaneous or systemic mastocytosis diagnosys attending the Dermatology Outpatient Clinics of the UOC Dermatology Unit Fondazione IRCCS Policlinico San Matteo
References
Publications (0)
Data not yet available