An observational study in Systemic Mastocytosis, sponsored by Associazione Rete Italiana Mastocitosi. Recruiting at 10 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Associazione Rete Italiana Mastocitosi · Observational
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:
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.
56 studies on the registry are indexed under Mastocytosis, Systemic; 16 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 155 across 18 observational studies indexed under Mastocytosis, Systemic.
Browse Mastocytosis, Systemic studies →This is the only study on the registry with Associazione Rete Italiana Mastocitosi as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients aged ≥ 18 years , with Diagnosis of mastocytosis according to current WHO criteria, will be enrolled
INCLUSION CRITERIA Age ≥ 18 years Diagnosis of mastocytosis according to current WHO criteria. Ability to give according to ICH/EU GCP, and national/local regulations.
EXCLUSION CRITERIA No exclusion criteria are expected.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: CLINICAL AND BIOLOGICAL DATA COLLECTION
CLINICAL AND BIOLOGICAL DATA COLLECTION IN A NATIONAL DATASET
To develop an understanding of the longitudinal clinical implications of mastocytosis, including disease natural history, treatments and outcomes, and variability in clinical care and disease burden.
Time frame: 5 YEARS
• To understand the prevalence, incidence, and clinical course associated with mastocytosis • To provide a source of longitudinal data to assist physicians with clinical management of individual patients • To act as a global repository for potential d
Time frame: 5 YEARS
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for May 2040, 204 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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