Flow CAST® Peanut Trial

ConditionPeanut Allergies

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age6+

SponsorBühlmann Laboratories AG

About this trial

This will be a multi-center, prospective evaluation, conducted at a minimum of four (4) U.S. sites. Sites will enroll peanut allergic subjects, subjects with allergies other than peanut and apparently healthy non-atopic control subjects and collect blood samples for testing using Flow CAST® and the comparative ImmunoCAP sIgE test.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Individual undergoing a blood draw

Individual willing and able to provide two additional tubes of blood (3ml each tube) for research purposes

Individual or legal guardian will and able to sign the informed consent form to participate in the study

Disqualifiers

Individual has undergone immunotherapy for peanuts or other identified allergens that have been shown to cause allergic symptoms

Individual has been exposed to systemically administered glucocorticoids within the last 24 hours.

Individual has been recently exposed to small molecule immunosuppressive medications

Individual has been recently exposed to treatment with biologics interfering with the type-I allergic pathway

Trial population

Adult subjects and pediatric subjects of at least 6 months of age are eligible for study enrollment.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Basophil activation test
Diagnostic test
Flow CAST® is a flow cytometry-based basophil activation test. Whole blood samples from patients are stimulated with specific allergens, as well as stimulation buffer and stimulation controls, to evaluate the patient's basophil degranulation in vitro

Treatment groups

245 Participants

are divided into 3 treatment groups

Group A: Non-atopic1 intervention

Group B: Atopic peanut1 intervention

Group C: Atopic non-peanut1 intervention

Trial outcomes

Primary outcomes

Clinical sensitivity of Flow CAST® with respect to a population of subjects with confirmed peanut allergy

Time frame

Within 48 hours after sample collection

Clinical specificity of Flow CAST® with respect to a population of apparently healthy non-atopic subjects

Time frame

Within 48 hours after sample collection

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bühlmann Laboratories AG

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: