Improved laboratory diagnostics for hypersensitivity reactions

Improved laboratory diagnostics for hypersensitivity reactions - IMPROVE-HR

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57288

Enrollment

100

Registered

2025-01-27

Start date

2025-05-21

Completion date

Unknown

Last updated

2026-06-08

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

Conditions

allergy Hypersensitivity

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Patients with (suspected) hypersensitivity (type 1 or type 4) o Patients with proven hypersensitivity (type 1 of type 4) will be included for development of the assays o Patients with suspected hypersensitivity (type 1 of type 4) will be included for validation purposes • Age >=18 • Informed consent given

Exclusion criteria

Exclusion criteria: • No informed consent • Insufficient knowledge of Dutch or English language and/or inability to understand the information provided. • Systemic immune suppressive treatment for the past 2 months

Design outcomes

Primary

Measure	Time frame
1) An optimized in vitro test to diagnose the culprit of the type 1 allergy, particularly allergens for which no commercial tests with sufficient sensitivity are available and/or to replace (oral) challenge of the patient. 2) An optimized in vitro test to diagnose the culprit of the type 4 allergy, particularly allergens that cannot be used to challenge the patient due to fear of recurrence of severe allergic reactions. 3) In vitro tests with sufficient sensitivity that can (partly) replace time and recourse consuming in vivo tests.	—

Measure

Time frame

1) An optimized in vitro test to diagnose the culprit of the type 1 allergy, particularly allergens for which no commercial tests with sufficient sensitivity are available and/or to replace (oral) challenge of the patient. 2) An optimized in vitro test to diagnose the culprit of the type 4 allergy, particularly allergens that cannot be used to challenge the patient due to fear of recurrence of severe allergic reactions. 3) In vitro tests with sufficient sensitivity that can (partly) replace time and recourse consuming in vivo tests.

—

Countries

Netherlands

Outcome results