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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48343

Enrollment

Registered

2019-02-01

Start date

2019-03-27

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mast cell abundance Mastocytosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - No (conclusive) bone marrow biopsy in patients with grade IV reactions. - Contra-indications for VIT - Minors (

Design outcomes

Primary

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

Secondary

Measure	Time frame
Changes in the profiles of gene expression and proteome of T- and B-cells are secondary outcomes for ISM+ and ISM- patients.	—

Countries

Netherlands

Outcome results