The Significance of Blood-tryptase and c-Kit Mutation in Insect Venom Immunotherapy

Completed

• Conditions: Mastocytosis; Hypersensitivity, Immediate; Insect Bites and Stings

• Registration Number: NCT02503800
• Lead Sponsor: Meir Medical Center

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.

Study Timeline

• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-21
• Study Start: 2015-08
• Primary Completion: 2019-02-15
• Study Completion: 2019-02-15
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-18
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• history of systemic response to hymenoptera sting.
• subject under current or planned venom immunotherapy.

Exclusion Criteria

• previously diagnosed mast cell disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The association between tryptase values/c-Kit mutation and immunotherapy adverse events will be evaluated using blood sample analysis and patient medical records.	up to 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel