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
Verified date | August 2019 |
Source | Meir Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Meir Medical Center | Kfar Saba |
Lead Sponsor | Collaborator |
---|---|
Meir Medical Center |
Israel,
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
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 |
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