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

Mastocytosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503800
• Other study ID #: MMC150100-15CTIL
• Status: Completed
• Start date: August 2015
• Est. completion date: February 15, 2019

Study information

• Verified date: August 2019
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: February 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 75 Years

Eligibility

Inclusion Criteria:

• history of systemic response to hymenoptera sting.

• subject under current or planned venom immunotherapy.

Exclusion Criteria:

• previously diagnosed mast cell disorder

Related Conditions & MeSH terms

• Bites and Stings
• Hypersensitivity
• Hypersensitivity, Immediate
• Insect Bites and Stings
• Mastocytosis

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Cichocka-Jarosz E, Sanak M, Szczeklik A, Brzyski P, Pietrzyk JJ. Impact of Hymenoptera venom allergy and the effects of specific venom immunotherapy on mast cell metabolites in sensitized children. Ann Agric Environ Med. 2014;21(2):294-301. doi: 10.5604/1232-1966.1108594. — View Citation

Niedoszytko M, de Monchy J, van Doormaal JJ, Jassem E, Oude Elberink JN. Mastocytosis and insect venom allergy: diagnosis, safety and efficacy of venom immunotherapy. Allergy. 2009 Sep;64(9):1237-45. doi: 10.1111/j.1398-9995.2009.02118.x. Epub 2009 Jul 21. Review. — View Citation

Zanotti R, Lombardo C, Passalacqua G, Caimmi C, Bonifacio M, De Matteis G, Perbellini O, Rossini M, Schena D, Busa M, Marcotulli MC, Bilò MB, Franchini M, Marchi G, Simioni L, Bonadonna P. Clonal mast cell disorders in patients with severe Hymenoptera ven — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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