Primary Objective: Difference in gene expression profiles in peripheral blood cells between reactors and non-reactors on a sting challenge with corresponding functional annotation and a naïve Bayes prediction model for patients at risk of a re-…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter: Genes for which the expression is significantly different
between reactors and non-reactors based on a log2 fold change > 2 in gene
expression, identify the corresponding functional annotation and building a
corresponding naïve Bayes prediction model to identify patients at risk for a
re-systemic reaction.
Secondary outcome
Secondary study parameter: Genes for which the expression after the sting
challenge is significantly different compared to base line expression levels
and identify the corresponding functional annotation.
Background summary
Patients with a history of anaphylactic sting reactions and a positive
allergological work-up including in-vitro tests and/or skin tests have a risk
of 50-60% of a re-systemic reaction. Strikingly, this risk is not 100%. Sting
challenges allow a more precise prognosis with respect to the risk of, and
severity of a systemic reaction on subsequent stings but are hampered by many
disadvantages. Gene expression analysis is a promising tool in this field, and
might provide a minimally invasive and highly sensitive tool to assess the risk
of a re-systemic reaction and elucidate pathways involved in mounting systemic
allergic reactions.
Study objective
Primary Objective: Difference in gene expression profiles in peripheral blood
cells between reactors and non-reactors on a sting challenge with corresponding
functional annotation and a naïve Bayes prediction model for patients at risk
of a re-systemic reaction. Secondary Objectives: Changes in the gene expression
profile compared to baseline during an acute systemic allergic reaction with
corresponding functional annotation.
Study design
Prospective case-control study.
Intervention
Blood sampling for gene expression analysis before and after the sting
challenge test.
Study burden and risks
Subjects participating in the study will visit the UMCG 1 to 3 times for a
sting challenge for approximately 3 hours. 7.5 ml of peripheral blood will be
drawn before each sting challenge. At the first sting challenge an additional
peripheral intravenous line will be placed for the collection of 32.5-87.5 ml
of venous blood divided over a set interval. The sting challenge is the gold
standard for the diagnosis of insect venom allergy and is a used procedure in
the University Medical Center Groningen to select patients eligible for venom
immunotherapy. Measures have been taken to reduce the chance of severe systemic
reactions by excluding patients at risk and administration of sting challenges
under intensive care conditions with an intravenous line at each sting and
constant medical attention.
Postbus 30.001
Groningen 9700 RB
NL
Postbus 30.001
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
* A clear positive history of a systemic response grade II, III or IVa after a vespid sting
* Vespid specific serum IgE > 0.35 kUA/l or a positive intracutaneous skin test for vespid venom (at <= 1 µg/ml a histamine equivalent prick of >=0.7)
written informed consent
Exclusion criteria
* A positive history of a systemic response grade IVb according to Mueller (13) after a vespid sting
* Age under 18 years or above 65 years
* Incapacitated subjects
* Severe cardiopulmonary disease (clinical evidence of congestive heart failure, coronary disease or severe hypertension)
* Insufficiently controlled asthma based on history, asthma control questionnaire and if the observed FEV1 is 70% of predicted.
* Conditions that influence the immune system (immune deficiencies, malignancy, auto-immune diseases, flulike dissease)
* Severe kidney failure
* Interfering medication with the outcome or recovery from a systemic reaction (β-blockers and immunosuppressive drugs)
* Pregnancy(measured before inclusion by β-hCG)
* Mastocytosis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44251.042.13 |