NCT06466889

Brief 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. Biologic samples are collected from available routine diagnostics (serum, skin tissue, gut mucosa, bone marrow, and others) for further use in experimental research.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
118mo left

Started Jun 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Jun 2024Dec 2035

Study Start

First participant enrolled

June 6, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Expected
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

1.6 years

First QC Date

June 13, 2024

Last Update Submit

June 24, 2024

Conditions

MastocytosisHypertryptasemia

Keywords

mast cell disease

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2010-2025

Study Arms (2)

Mastocytosis

Diagnosed mastocytosis according to WHO criteria

Hypertryptasemia

Repeated elevated serum tryptase with no underlying mastocytosis or no bone marrow biopsy performed

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients with mastocytosis or hypertryptasemia

You may qualify if:

  • Adult patients with mastocytsis/hypertryptasemia which are treated at the university hospital of Zurich
  • available informed consent

You may not qualify if:

  • denied consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

PBMC, skin samples, gut tissue, bone marrow

MeSH Terms

Conditions

MastocytosisMast Cell Activation Disorders

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsImmune System Diseases

Central Study Contacts

Claudia Lang, MD

CONTACT

+41442551111claudia.lang@usz.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 20, 2024

Study Start

June 6, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2035

Last Updated

June 26, 2024

Record last verified: 2024-06

Locations

CH(1)