Hypersensitivity, ImmediateNCT02503800
The Significance of Blood-tryptase and c-Kit Mutation in Insect Venom Immunotherapy
An observational study of Hypersensitivity, Immediate and Insect Bites and Stings, run by Meir Medical Center at 1 site in Israel.
Trial 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 more about this study
- Who is it for?
- Ages 4 to 75 years
- Conditions the study is for
- Hypersensitivity, Immediate, Insect Bites and Stings, Mastocytosis
- How many people
- 159 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2015to 15 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population will include all the subjects undergoing venom immunotherapy at the Clinic of Allergy and Clinical Immunology, Meir Medical Center.
Who may be able to join
- history of systemic response to hymenoptera sting.
- subject under current or planned venom immunotherapy.
Who cannot join
- previously diagnosed mast cell disorder
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Medical subject headings
- Hypersensitivity, Immediate, Insect Bites and Stings, Mastocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| subjects undergoing venom immunotherapy | The study group will include all the subjects receiving routine venom immunotherapy at the Meir Medical Center Allergy Clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between tryptase values/c-Kit mutation and immunotherapy adverse events will be evaluated using blood sample analysis and patient medical records.
Measured: 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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypersensitivity, ImmediateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alon hershko, Meir Medical Center
- Investigators
- Alon Y Hershko, MD, PhD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503800
- Sponsor's protocol ID
- MMC150100-15CTIL
- Status last verified
- Aug 2019
- First submitted
- 16 Jul 2015
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
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 24959779Niedoszytko 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 19627278Zanotti 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02503800
- Acronym / sponsor ID
- MMC150100-15CTIL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects undergoing venom immunotherapy | – | –The study group will include all the subjects receiving routine venom immunotherapy at the Meir Medical Center Allergy Clinic. |
Who may qualify
- Ages
- 4 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population will include all the subjects undergoing venom immunotherapy at the Clinic of Allergy and Clinical Immunology, Meir Medical Center.
Key inclusion criteria (2 listed)
- history of systemic response to hymenoptera sting.
- subject under current or planned venom immunotherapy.
Key exclusion criteria (1 listed)
- previously diagnosed mast cell disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Background: PubMed 24959779Cichocka-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.
- Background: PubMed 19627278Niedoszytko 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.
- Results publication: PubMed 25605272Zanotti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alon Y Hershko, MD, PhD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersensitivity, Immediate and Insect Bites and Stings, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02503800, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.