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

NCT02503800 | Completed DMC

• 1 other identifier: MMC150100-15CTIL
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypersensitivity, Immediate; Insect Bites and Stings; Mastocytosis

Outcome Measures

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.

  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.

  up to 12 months

Study Arms (1)

subjects undergoing venom immunotherapy

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

Eligibility Criteria

• Age: 4 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• previously diagnosed mast cell disorder

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

Related 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.

  PMID: 24959779 BACKGROUND

• 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.

  PMID: 19627278 BACKGROUND

• 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.

  PMID: 25605272 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen will include 5 ml of venous whole blood drawn for measurement of serum tryptase and leukocyte c-Kit mutation.

MeSH Terms

Conditions

Hypersensitivity, Immediate; Insect Bites and Stings; Mastocytosis

Condition Hierarchy (Ancestors)

Hypersensitivity; Immune System Diseases; Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Mast Cell Activation Disorders

Study Officials

• Alon Y Hershko, MD, PhD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Medicine B

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 21, 2015
• Study Start: August 1, 2015
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

IL (1)