The Significance of Blood-tryptase Levels and c-Kit Mutation in the Evaluation of Prognosis and Adverse Reactions in Subjects Undergoing Venom Immunotherapy for Insect Allergy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mastocytosis
- Sponsor
- Meir Medical Center
- Enrollment
- 159
- Locations
- 1
- Primary Endpoint
- The association between tryptase values/c-Kit mutation and immunotherapy adverse events will be evaluated using blood sample analysis and patient medical records.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The investigators wish to evaluate the association between tryptase values as well as c-Kit mutation and adverse effects in the course of immunotherapy. The investigators also intend to assess the effect of immunotherapy on tryptase levels.
Detailed Description
According to the presently available reports there is an association between systemic allergic responses to hymenoptera venom and elevated tryptase levels or c-Kit mutation. The presence of these findings may imply the existence of mast cell activation syndrome or mastocytosis. Therefore, baseline tryptase evaluation has become standard evaluation in patients with systemic responses. Meir Medical Center is the only hospital in Israel in which tryptase can be measured. Consequently, the Meir Clinic has accumulated considerable data with regards to tryptase levels in subjects with allergy to hymenoptera venom. The investigators wish to evaluate the association between tryptase values as well as c-Kit mutation and adverse effects in the course of immunotherapy. The investigators also intend to assess the effect of immunotherapy on tryptase levels.
Investigators
alon hershko
Chairman, Department of Medicine B
Meir Medical Center
Eligibility Criteria
Inclusion Criteria
- •history of systemic response to hymenoptera sting.
- •subject under current or planned venom immunotherapy.
Exclusion Criteria
- •previously diagnosed mast cell disorder
Outcomes
Primary Outcomes
The association between tryptase values/c-Kit mutation and immunotherapy adverse events will be evaluated using blood sample analysis and patient medical records.
Time Frame: up to 12 months
Secondary Outcomes
- The association between tryptase values/c-Kit mutation and severity of index sting event will be evaluated using blood sample analysis and patient medical records.(up to 12 months)