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Gene expression analysis elucidating pathogenic mechanisms and predicting vespid venom anaphylaxis

Gene expression analysis elucidating pathogenic mechanisms and predicting vespid venom anaphylaxis - GEIVA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38535
Enrollment
20
Registered
2013-08-09
Start date
2013-09-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vespid venom allergy wasp venom allergy

Interventions

Blood sampling for gene expression analysis before and after the sting challenge test.

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 =0.7) written informed consent

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)