MastocytosisMastoRNCT06466889
Mastocytosis Registry (of Zurich)
An observational study of Mastocytosis and Hypertryptasemia, run by University of Zurich at 1 site in Switzerland.
Trial summary
The study aims to summarize patients with mastocytosis and hypertryptasämia (without underlying mastocytosis or no bone marrow biopsy) in relation to demographic information, clinical progress and treatment courses. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mastocytosis, Hypertryptasemia
- How many people
- 400 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Jun 2024to 31 Dec 2035
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: all patients with mastocytosis or hypertryptasemia
Who may be able to join
- Adult patients with mastocytsis/hypertryptasemia which are treated at the university hospital of Zurich
- available informed consent
Who cannot join
- denied consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Zurich
Zurich, 8091
Claudia Lang, MD, +41442551111, claudia.lang@usz.ch
About this study
Official title: Genetic, Multiomic and Cytokine-based Mapping of Patients With Mastocytosis/Hypertryptasemia at the University Hospital of Zurich German: Mastozytose-Register: Datenerfassung Und Weiterverwendung Von Biologischem Material Von Patienten Mit Mastozytose, Welche am Universitätsspital Zürich Behandelt Werden
The study aims to summarize patients with mastocytosis and hypertryptasämia (without underlying mastocytosis or no bone marrow biopsy) in relation to demographic information, clinical progress and treatment courses. Biologic samples are collected from available routine diagnostics (serum, skin tissue, gut mucosa, bone marrow, and others) for further use in experimental research.
- Conditions
- Mastocytosis, Hypertryptasemia
- Keywords
- mast cell disease
- Medical subject headings
- Mastocytosis, Mast Cell Activation Disorders
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 |
|---|---|---|
| Mastocytosis | Diagnosed mastocytosis according to WHO criteria | |
| Hypertryptasemia | Repeated elevated serum tryptase with no underlying mastocytosis or no bone marrow biopsy performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
In the registry we collect patient's demographic data e.g. age, gender, comorbidities, smoking, preexisting atopic disease and other to look for associations to mast cell diseases.
Measured: 2010-2025
Disease progression
Patients will followed up over time to get more insight in disease progression.If there is progression detected (e.g. cutaneous mastocytosis to systemic mastocytosis or ISM to advanced forms) those cases will be carefully looked at to identify triggering factors and biomarkers.
Measured: 2010-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start6 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastocytosisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466889
- Sponsor's protocol ID
- BASEC 2020-01568
- Acronym
- MastoR
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: set up multicenter registry, patient data will be anonymous
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic, Multiomic and Cytokine-based Mapping of Patients With Mastocytosis/Hypertryptasemia at the University Hospital of Zurich German: Mastozytose-Register: Datenerfassung Und Weiterverwendung Von Biologischem Material Von Patienten Mit Mastozytose, Welche am Universitätsspital Zürich Behandelt Werden
- ClinicalTrials.gov ID
- NCT06466889
- Acronym / sponsor ID
- MastoR / BASEC 2020-01568
- Conditions
- Mastocytosis, Hypertryptasemia
- Keywords
- mast cell disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 20 Jun 2024 (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.
The study aims to summarize patients with mastocytosis and hypertryptasämia (without underlying mastocytosis or no bone marrow biopsy) in relation to demographic information, clinical progress and treatment courses. Biologic samples are collected from available routine diagnostics (serum, skin tissue, gut mucosa, bone marrow, and others) for further use in experimental research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mastocytosis | – | –Diagnosed mastocytosis according to WHO criteria |
| Hypertryptasemia | – | –Repeated elevated serum tryptase with no underlying mastocytosis or no bone marrow biopsy performed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with mastocytosis or hypertryptasemia
Key inclusion criteria (2 listed)
- Adult patients with mastocytsis/hypertryptasemia which are treated at the university hospital of Zurich
- available informed consent
Key exclusion criteria (1 listed)
- denied consent
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
Demographics
Time frame: 2010-2025
In the registry we collect patient's demographic data e.g. age, gender, comorbidities, smoking, preexisting atopic disease and other to look for associations to mast cell diseases.
Disease progression
Time frame: 2010-2025
Patients will followed up over time to get more insight in disease progression.If there is progression detected (e.g. cutaneous mastocytosis to systemic mastocytosis or ISM to advanced forms) those cases will be carefully looked at to identify triggering factors and biomarkers.
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 Jun 2024.
- Individual participant dataSharing planned: Undecided. set up multicenter registry, patient data will be anonymous
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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 Mastocytosis and Hypertryptasemia, run by University of Zurich at 1 site in Switzerland.
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 2 inclusion and 1 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 Jun 2024. 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 Switzerland. 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 Claudia Lang, MD (+41442551111, claudia.lang@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics (time frame: 2010-2025). The study lists 2 primary outcomes in all. 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 Jun 2024.