abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies

Withdrawn before enrolling

Conditions studied: Allergy, Allergic Asthma, Allergy to Cats, Allergy to House Dust, Allergy to Dog Dander, Allergy Cockroach

In brief

This is a multicenter, prospective, observational study designed to determine the clinical sensitivity and specificity of the Abionic IVD CAPSULE Allergic Asthma panel performed on Abionic's abioSCOPE device using K3-EDTA anticoagulated plasma samples from atopic and non-atopic pediatric and adult patients. Patients' sensitization determined with the abioSCOPE will be compared to the clinical assessment of allergy.

Key facts

Study ID

NCT04442932

Run by

Abionic SA

People needed

0

Starts

2020-11-15

Expected to finish

2021-03-15

Last updated by the study team

2020-10-05

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Atopic and non-atopic individuals are needed for this study. For enrollment in the atopic arm, patients must meet all of the inclusion criteria listed below to be eligible for participation:
• Provide signed and dated written informed consent by patient or legally designated representative prior to any mandatory study-specific procedures, sample collection, or analysis. Assent will be obtained from pediatric patients who are ≥ 6 years of age and less than 18 years of age.
• Male or female, ≥ 6 years of age.
• Consulting for signs and/or symptoms of IgE-mediated allergies to perennial allergens.
• For enrollment in the non-atopic arm, patients must meet all of the inclusion criteria list below to be eligible for participation:
• Provide signed and dated written informed consent by patient or legally designated representative prior to any mandatory study-specific procedures, sample collection, or analysis. Assent will be obtained from pediatric patients who are ≥ 6 years of age and less than 18 years of age.
• Male or female, ≥ 6 years of age.
• Apparently healthy individuals who exhibit no signs/symptoms of IgE-mediated allergies including rhinitis, conjunctivitis, asthma, eczema, urticaria or food allergy symptoms upon exposure to animal danders, dust mites, cockroaches, pollens or food allergens (non-atopic).

You may not qualify if…

• Patients must not meet any exclusion criteria below to be eligible for participation:
• Patient participating in another study that may influence test results.
• Subjects taking any of the following medications: antihistamines in the week preceding the consultation, systemic steroids (inhaled or nasal steroids are allowed), anti-cytokines or cytokines, systemic interferon (injection local interferon α for the treatment of HPV is allowed), anti-IgE therapy (approved or investigational) or treated with systemic chemotherapy.
• On-going allergen immunotherapy or prior allergen immunotherapy within the prior 3 years.
• Patient with a history of cancer, autoimmune, or immune deficiency disease.
• Patient suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood test.
• Known severe allergic reaction to any of the IVD CAPSULE Allergic Asthma panel allergen components

Where it is running

• George Washington University, Washington DC — Washington D.C., District of Columbia, United States
• Johns Hopkins University, Baltimore — Baltimore, Maryland, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Creticos Research Group, LLC — Crownsville, Maryland, United States
• The Bernstein Clinical Research Center Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.