Current laboratory tests for hypersensitivity are not sensitive of do not exist for certain allergens omong which medical drugs. To objective is therefore to optimize existing in vitro tests (lymphocyte activation and proliferation test, cytokine…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
NA
Background summary
Allergy is on the rise worldwide leading to an increase in patients referred to
a specialist, and growing waiting lists. The current gold standard for
diagnosis is the in vivo test. In vivo tests have as down side that they are
very time consuming and can pertain a certain risk to the patient as they are
re-exposed to a potential, severe allergen. This can lead to (temporary)
discomfort, but theoretically also to life-threatening recurrence of the
allergic reaction. In vitro testing, using laboratory assays, would circumvent
these risks and make diagnostics more readily available in current times of
growing numbers of allergic patients.
Study objective
Current laboratory tests for hypersensitivity are not sensitive of do not exist
for certain allergens omong which medical drugs. To objective is therefore to
optimize existing in vitro tests (lymphocyte activation and proliferation test,
cytokine production tests and (indirect) basophil activation test (BAT) to
diagnose type 1 and type 4 hypersensitivity with high sensitivity and
specificity.
Study design
Prospective test comparison study
Study burden and risks
Subjects participating in the study will not experience any delay, disadvantage
in their medical care nor miss any regular treatment. Vena puncture to draw
blood may result in a temporary hematoma at the site of puncture. The results
of this study will have no direct impact on the patient*s treatment. However,
it is important to remember that the knowledge gained may have an impact on our
future practice in the diagnosis of allergic diseases.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
• 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
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 | NL86689.018.24 |