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| Name | Class |
|---|---|
| Technical University Munchen | UNKNOWN |
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The goal of this exploratory pilot study is to generate early data needed for future validation studies of the automated BÜHLMANN BAT (Basophil activation test) assay. The main questions it aims to answer are:
Does the BAT assay use the optimal allergen concentrations for stimulation, and how do its preliminary cut-offs perform in a real-world clinical scenario?
Participants older than 1.5 years who are being evaluated for possible allergy sensitization will provide one additional blood tube during their routine blood draw as part of the regular medical care. The study involves only one visit and does not provide direct personal benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allergy / hypersensitivity to the 6 allergens | 10 patients, each with an allergy / hypersensitivity to the following allergens: (i) Peanut, (ii) Hazelnut, (iii) Honey Bee, (iv) Yellow Jacket Venom, (v) House Dust Mite (HDM) (vi) Cat Epithelium. No additional non-allergic control subjects will be recruited specifically for this study. Participants with a clinically confirmed hypersensitivity to one of the six investigated allergens will serve as allergen-specific controls for the remaining allergens for which they have no known hypersensitivity. |
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| Measure | Description | Time Frame |
|---|---|---|
| To verify and confirm the optimal allergen concentration for stimulation and preliminary cut-offs in BÜHLMANN BAT | To verify and confirm the optimal allergen concentration for stimulation and preliminary cut-offs in BÜHLMANN BAT using fresh whole blood samples from clinically characterized allergic individuals (mainly using patient's history, skin prick test, detection of sIgE, basophil activation test or provocation test). | From enrollment to the end of study at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Verification of agreement between tested BAT and the Certified BÜHLMANN Flow CAST® Basophil Activation Test | From enrollment to the end of study at 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be invited during a routine diagnostic visit to the Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein to contribute to the study by giving one additional sample tube. This extra sample will be collected alongside the venous blood samples already being taken as part of their standard care.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein, TUM Universitätsklinikum rechts der Isar, | Recruiting | München | Germany |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D000092422 | Venom Hypersensitivity |
| D000092542 | Dust Mite Allergy |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| D007154 | Immune System Diseases |
| D012221 | Rhinitis, Allergic, Perennial |
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |