Cutaneous MastocytosisMaReNCT07142473
Mastocytosis From Pediatric Age to Adulthood: Local Registry of Cutaneous and Systemic Mastocytosis
An observational study of Cutaneous Mastocytosis and Systemic Mastocytosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cutaneous Mastocytosis, Systemic Mastocytosis
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jan 2024to 26 Jan 2034
- How long will I take part?
- 10 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients diagnosed with cutaneous or systemic mastocytosis attending the Dermatology Outpatient Clinics of the UOC Dermatology Unit Fondazione Policlinico San Matteo IRCCS Pavia will be eligible for inclusion in the registry.
Who may be able to join
- Cutaneous or systemic mastocytosis diagnosys attending the Dermatology Outpatient Clinics of the UOC Dermatology Unit Fondazione IRCCS Policlinico San Matteo
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
SC Dermatologia, Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, 27100
Valeria Brazzelli, MD, 0382503794, v.brazzelli@smatteo.pv.it
About this study
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
- Cutaneous Mastocytosis, Systemic Mastocytosis
- Medical subject headings
- Mastocytosis, Cutaneous, Mastocytosis, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients diagnosed with cutaneous or systemic mastocytosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of the systemic disease variant in the examined population
The prevalence and the 95% exact binomial confidence interval will be presented
Measured: January 2034
Secondary outcomes (5)
Association between clinical, serological, hematological, and molecular characteristics and the disease variant (cutaneous or systemic)
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
Measured: January 2034
Association between family history and age of disease onset
The analysis will be performed using a multivariate logistic model
Measured: January 2034
Survival rate in relation to the disease variant (cutaneous or systemic)
The survival rate will be reported as deaths per 100 person-years; the start date for follow-up will be the diagnosis of the disease. The groups will be compared using the log-rank test, and survival will be described using Kaplan-Meier curves. A Cox model will be used to derive the hazard ratio (HR) and the corresponding 95% confidence interval (CI). Harrell's C-statistic will be calculated to assess the model's discriminatory ability. Estimates will be adjusted, where possible, for potential confounding factors
Measured: January 2034
Association between c-KIT mutation in blood and clinical characteristics of the patient
The analysis will be performed using a multivariate logistic model
Measured: January 2034
Evaluation of dermatoscopic characteristics in relation to the clinical presentation of the disease and the patient's age
The analysis will be performed using a multivariate logistic model. For the purposes of the analysis, age will be dichotomized at the median. Linear regression models may also be used
Measured: January 2034
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start26 Jan 2024
- Primary completion26 Jan 2034 (estimated)
- Study completion26 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MastocytosisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valeria Brazzelli, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142473
- Sponsor's protocol ID
- MaRe
- Acronym
- MaRe
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastocytosis From Pediatric Age to Adulthood: Local Registry of Cutaneous and Systemic Mastocytosis
- ClinicalTrials.gov ID
- NCT07142473
- Acronym / sponsor ID
- MaRe / MaRe
- Conditions
- Cutaneous Mastocytosis, Systemic Mastocytosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 26 Jan 2034 (estimated)
- Study completion
- 26 Jan 2034 (estimated)
- First posted
- 26 Aug 2025 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed with cutaneous or systemic mastocytosis | – | – |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients diagnosed with cutaneous or systemic mastocytosis attending the Dermatology Outpatient Clinics of the UOC Dermatology Unit Fondazione Policlinico San Matteo IRCCS Pavia will be eligible for inclusion in the registry.
Key inclusion criteria (1 listed)
- Cutaneous or systemic mastocytosis diagnosys attending the Dermatology Outpatient Clinics of the UOC Dermatology Unit Fondazione IRCCS Policlinico San Matteo
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of the systemic disease variant in the examined population
Time frame: January 2034
The prevalence and the 95% exact binomial confidence interval will be presented
5 secondary outcomes
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
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 26 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Mastocytosis and Systemic Mastocytosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. 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 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Valeria Brazzelli, MD (03820503794, v.brazzelli@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of the systemic disease variant in the examined population (time frame: January 2034). 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 26 Aug 2025.