Immunological analyses of Long-term Molecular and Cellular Responses to Hymenoptera Venom Immunotherapy Indolent Systemic Mastocytosis patients.

Recruiting

• Conditions: mast cell abundance; Mastocytosis; 10001708; 10018865

• Registration Number: NL-OMON48343
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

- A systemic reaction to an wasp sting, grade IV according to the Muller classification.
- Diagnostic confirmation by specific IgE levels against wasp venom.
- A conclusive bone marrow biopsy confirming or excluding the presence of mastocytosis or the presence of monoclonal mast cell disease.
- The patient has chosen VIT as treatment of HVA.

Exclusion Criteria

- No (conclusive) bone marrow biopsy in patients with grade IV reactions.
- Contra-indications for VIT
- Minors (<18 years)
- Legally incapacitated patients

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome will be the change in fraction (fraction expressed as<br /><br>percentage) of proliferating Th2-cells, defined by IL-4 expression and low<br /><br>expression of CFSE, within the allergen-specific CD4+ T-cell population within<br /><br>both patient groups, ISM and non-ISM after thirteen weeks and seven months of<br /><br>VIT.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes in the profiles of gene expression and proteome of T- and B-cells are<br /><br>secondary outcomes for ISM+ and ISM- patients.</p><br>