Flow CAST® Peanut 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.

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Key information

Conditions

Peanut Allergies Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nut and Peanut Hypersensitivity Peanut Hypersensitivity

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Sponsors and collaborators

Lead sponsor

Bühlmann Laboratories AG

Industry

Registry information

Official study title

Clinical Evaluation of Flow CAST® as an Aid in the Diagnosis of Peanut Allergy

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Aug 20, 2026
Registry last updated: Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not yet recruiting