Flow CAST® Peanut Trial

N/ANot Yet RecruitingNCT07775430

Bühlmann Laboratories AG245 enrolled

Overview

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.

Study subjects will be enrolled into one of the following 3 groups: healthy non-atopic subjects with no history of allergies, atopic subjects with confirmed peanut allergy, atopic subjects with a diagnosed allergy but confirmed negative for peanut allergy. Subgroup analysis will be performed for each of the above categories.

Study Type

OBSERVATIONAL

Enrollment

245

Conditions

Peanut Allergies

Interventions

Basophil activation testDIAGNOSTIC_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

Eligibility

Sex: ALLMin age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Individual is currently involved in another "allergy treatment related" clinical research study

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

Data from ClinicalTrials.gov

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