The Significance of Blood-tryptase and c-Kit Mutation in Insect Venom Immunotherapy
August 18, 2019 updated by: alon hershko, Meir Medical Center
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
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 Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
159
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kfar Saba, Israel
- Meir Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The population will include all the subjects undergoing venom immunotherapy at the Clinic of Allergy and Clinical Immunology, Meir Medical Center.
Description
Inclusion Criteria:
- history of systemic response to hymenoptera sting.
- subject under current or planned venom immunotherapy.
Exclusion Criteria:
- previously diagnosed mast cell disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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subjects undergoing venom immunotherapy
The study group will include all the subjects receiving routine venom immunotherapy at the Meir Medical Center Allergy Clinic.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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up to 12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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.
Time Frame: up to 12 months
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up to 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alon Y Hershko, MD, PhD, Meir Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
February 15, 2019
Study Completion (Actual)
February 15, 2019
Study Registration Dates
First Submitted
July 16, 2015
First Submitted That Met QC Criteria
July 20, 2015
First Posted (Estimate)
July 21, 2015
Study Record Updates
Last Update Posted (Actual)
August 20, 2019
Last Update Submitted That Met QC Criteria
August 18, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Skin Diseases
- Immune System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Wounds and Injuries
- Neoplasms, Connective Tissue
- Poisoning
- Immune Complex Diseases
- Hypersensitivity
- Mastocytosis
- Hypersensitivity, Immediate
- Bites and Stings
- Insect Bites and Stings
Other Study ID Numbers
- MMC150100-15CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.