Systemic MastocytosisNIMRNCT07917156
New Italian Mastocytosis Registry
An observational study of Systemic Mastocytosis, run by Associazione Rete Italiana Mastocitosi at 10 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Mastocytosis
- What is being tested?
- CLINICAL AND BIOLOGICAL DATA COLLECTION
- How many people
- 1,500 participants
- Where
- 10 sitesItaly
- Study dates
- 15 May 2023to May 2040
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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 informed consent according to ICH/EU GCP, and national/local regulations.
EXCLUSION CRITERIA No exclusion criteria are expected.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Italy10 sites, 10 recruiting
- Recruiting
UOS Allergologia - ASST LARIANA
Como
MARINA MAURO, +39031.585.5567, marina.mauro@asst-lariana.it
- Recruiting
Centro di Ricerca e Innovazione per le Malattie Mieloproliferative Università degli Studi di Firenze Azienda Ospedaliero- Universitaria Careggi
Florence
FRANCESCO MANNELLI, MD, +393383397691, francesco.mannelli@unifi.it
- Recruiting
Asst Grande Ospedale Metropolitano Niguarda
Milan
JAN SCHROEDER, +390264442082, janwaltervolk.schroeder@ospedaleniguarda.it
- Recruiting
Policlinico Irccs Ca Granda
Milan
MARIA RITA SCIUME, +393208483365, mariarita.sciume@policlinico.mi.it
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
CHIARA ELENA, MD, +393395408676, chiara.elena1@gmail.com
- Recruiting
sANTA MARIA DELLE CROCI AUSL ROMAGNA
Ravenna
MICHELA RONDONI, MD, +393356954256, michela.rondoni@auslromagna.it
- Recruiting
Uoc Ematologia E Trapianto Cellule Staminali Universita Cattolica Del Sacrocuore Fondazione Policlinico Universitario Gemelli
Roma
LIVIO PAGANO, +390630155300, livio.pagano@unicatt.it
- Recruiting
UO Diagnosi e Terapia delle Malattie Allergiche e del Sistema Immunitario A.O.U. OO.RR. San Giovanni di Dio e Ruggi D'Aragona
Salerno
MASSIMO TRIGGIANI, +393355617433, mtriggiani@unisa.it
- Recruiting
Università degli Studi Ospedale Borgo Roma Policlinico G. B. Rossi
Verona
MASSIMILIANO BONIFACIO, MD, +393495623655, massimiliano.bonifacio@univr.it
- Recruiting
UO Allergologia Ospedale San Bortolo Vicenza
Vicenza
PATRIZIA BONADONNA, +393392798162, patrizia.bonadonna@aovr.veneto.it
About this study
Official title: A Retrospective/Prospective, Multi-Center, Observational Registry Compiling Data on the Natural History and Management of Patients Diagnosed With Mastocytosis
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.
Read more
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.
- Conditions
- Systemic Mastocytosis
- Being tested
- CLINICAL AND BIOLOGICAL DATA COLLECTION
- Medical subject headings
- Mastocytosis, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLINICAL AND BIOLOGICAL DATA COLLECTIONOther
CLINICAL AND BIOLOGICAL DATA COLLECTION IN A NATIONAL DATASET
| Study group | Role | What they receive |
|---|---|---|
| Patients with Mastocytosis followed at Italian participant centers | Not described Receives: Other: CLINICAL AND BIOLOGICAL DATA COLLECTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 YEARS
Secondary outcomes (1)
• 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
Measured: 5 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start15 May 2023
- Primary completionMay 2040 (estimated)
- Study completionMay 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic MastocytosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Associazione Rete Italiana Mastocitosi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROBERTA ZANOTTI, MD, Study chair, RIMA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917156
- Sponsor's protocol ID
- NIMR
- Acronym
- NIMR
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective/Prospective, Multi-Center, Observational Registry Compiling Data on the Natural History and Management of Patients Diagnosed With Mastocytosis
- ClinicalTrials.gov ID
- NCT07917156
- Acronym / sponsor ID
- NIMR / NIMR
- Conditions
- Systemic Mastocytosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Associazione Rete Italiana MastocitosiUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- May 2040 (estimated)
- Study completion
- May 2040 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Mastocytosis followed at Italian participant centers | – | Other: CLINICAL AND BIOLOGICAL DATA COLLECTION |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥ 18 years , with Diagnosis of mastocytosis according to current WHO criteria, will be enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLINICAL AND BIOLOGICAL DATA COLLECTIONCLINICAL AND BIOLOGICAL DATA COLLECTION IN A NATIONAL DATASET | Other | Patients with Mastocytosis followed at Italian participant centers |
Primary outcome
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
1 secondary outcome
• 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ROBERTA ZANOTTI, MD study chair
RIMA
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Mastocytosis, run by Associazione Rete Italiana Mastocitosi at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ROBERTA ZANOTTI, MD (+393332594320, associazionerima@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.