Flow CAST® Peanut Trial

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07775430

Enrollment

245

Registered

2026-08-20

Start date

2026-10-01

Completion date

2027-12-31

Last updated

2026-08-20

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

Conditions

Peanut Allergies

Keywords

Food allergy, peanut allergy, allergy, peanut

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTBasophil activation 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

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

6 Months to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Clinical sensitivity of Flow CAST® with respect to a population of subjects with confirmed peanut allergy	Within 48 hours after sample collection
Clinical specificity of Flow CAST® with respect to a population of apparently healthy non-atopic subjects	Within 48 hours after sample collection

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026