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CompletedNCT02503800Updated Aug 20, 2019

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

An observational study in Hypersensitivity, Immediate, Insect Bites and Stings and Mastocytosis, sponsored by Meir Medical Center. Completed at 1 site in Israel. Open to participants aged 4 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-20.

Sponsored by Meir Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
159
Ages
4 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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

Hypersensitivity, Immediate

82 studies on the registry are indexed under Hypersensitivity, Immediate; 7 are open to participants now.

This study's enrollment of 159 is close to the median of 159 across 11 observational studies indexed under Hypersensitivity, Immediate.

Browse Hypersensitivity, Immediate studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 401 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • previously diagnosed mast cell disorder
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
159 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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 researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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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Study locations

1 site
  • Meir Medical Center
    Kfar Saba, Israel
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References and documents

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. PubMed 24959779 ↗
  • 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. PubMed 19627278 ↗
  • 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. PubMed 25605272 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2015, a primary completion of Feb 2019 and a completion of Feb 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2015
First posted
Jul 21, 2015
Start
Aug 2015
Primary completionActual
Feb 15, 2019
CompletionActual
Feb 15, 2019
Last update
Aug 20, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02503800
Responsible party
alon hershko (Chairman, Department of Medicine B, Meir Medical Center) — Principal investigator
First posted
Jul 21, 2015
Start date
Aug 2015
Primary completion
Feb 15, 2019
Completion
Feb 15, 2019
Last update
Aug 20, 2019

Study contacts

Alon Y Hershko, MD, PhD
principal investigator · Meir Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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