Status:
WITHDRAWN
abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies
Lead Sponsor:
Abionic SA
Collaborating Sponsors:
NAMSA
Johns Hopkins University
Conditions:
Allergy
Allergic Asthma
Eligibility:
All Genders
6+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
November 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04442932
Start Date
November 15 2020
End Date
March 15 2021
Last Update
October 5 2020
Active Locations (5)
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1
George Washington University, Washington DC
Washington D.C., District of Columbia, United States, 20037
2
Johns Hopkins University, Baltimore
Baltimore, Maryland, United States, 21215
3
Johns Hopkins
Baltimore, Maryland, United States, 21287
4
Creticos Research Group, LLC
Crownsville, Maryland, United States, 20132