- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06466889
Mastocytosis Registry (of Zurich) (MastoR)
June 24, 2024 updated by: University of Zurich
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Claudia Lang, MD
- Phone Number: +41442551111
- Email: claudia.lang@usz.ch
Study Locations
-
-
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Zurich, Switzerland, 8091
- Recruiting
- University Hospital of Zurich
-
Contact:
- Claudia Lang, MD
- Phone Number: +41442551111
- Email: claudia.lang@usz.ch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
all patients with mastocytosis or hypertryptasemia
Description
Inclusion Criteria:
- Adult patients with mastocytsis/hypertryptasemia which are treated at the university hospital of Zurich
- available informed consent
Exclusion Criteria:
- denied consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Mastocytosis
Diagnosed mastocytosis according to WHO criteria
|
|
Hypertryptasemia
Repeated elevated serum tryptase with no underlying mastocytosis or no bone marrow biopsy performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2010-2025
|
|
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.
|
2010-2025
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2035
Study Registration Dates
First Submitted
June 13, 2024
First Submitted That Met QC Criteria
June 18, 2024
First Posted (Actual)
June 20, 2024
Study Record Updates
Last Update Posted (Actual)
June 26, 2024
Last Update Submitted That Met QC Criteria
June 24, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BASEC 2020-01568
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
set up multicenter registry, patient data will be anonymous
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mastocytosis
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University Hospital, ToulouseCompletedIndolent Systemic Mastocytosis | Cutaneous MastocytosisFrance
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Blueprint Medicines CorporationAnalysis Group, Inc.CompletedMast Cell Leukemia | Aggressive Systemic Mastocytosis | Advanced Systemic Mastocytosis | Systemic Mastocytosis With an Associated Hematological NeoplasmUnited States, Austria, Germany, Spain, United Kingdom