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

NCT ID: NCT02503800

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 159 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2019-02-15

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.

Conditions

Hypersensitivity, Immediate; Insect Bites and Stings; Mastocytosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

subjects undergoing venom immunotherapy

The study group will include all the subjects receiving routine venom immunotherapy at the Meir Medical Center Allergy Clinic.

No interventions assigned to this group

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

alon hershko

Chairman, Department of Medicine B

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alon Y Hershko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

Meir Medical Center

Kfar Saba, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 24959779 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19627278 (View on PubMed)

Zanotti R, Lombardo C, Passalacqua G, Caimmi C, Bonifacio M, De Matteis G, Perbellini O, Rossini M, Schena D, Busa M, Marcotulli MC, Bilo MB, Franchini M, Marchi G, Simioni L, Bonadonna P. Clonal mast cell disorders in patients with severe Hymenoptera venom allergy and normal serum tryptase levels. J Allergy Clin Immunol. 2015 Jul;136(1):135-9. doi: 10.1016/j.jaci.2014.11.035. Epub 2015 Jan 17.

Reference Type: RESULT

PMID: 25605272 (View on PubMed)

Other Identifiers

MMC150100-15CTIL

Identifier Type: -

Identifier Source: org_study_id