Flow CAST® Peanut Trial

NCT07775430 | Not Yet Recruiting FDA Device

• 1 other identifier: BUHL FC F13 01
• Study Type: observational
• Target: 245
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peanut Allergies

Keywords

Food allergy; peanut allergy; allergy; peanut

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Non-atopic

Healthy non-atopic subjects with no history of allergies

Diagnostic Test: Basophil activation test

Atopic peanut

Atopic subjects with confirmed peanut allergy

Diagnostic Test: Basophil activation test

Atopic non-peanut

Atopic subjects with a diagnosed allergy but confirmed negative for peanut allergy

Diagnostic Test: Basophil activation test

Interventions

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

Atopic non-peanut; Atopic peanut; Non-atopic

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bühlmann Laboratories AG: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum or plasma

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity

Interventions

Basophil Degranulation Test

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share