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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04442932
Other study ID # AB-ALL-003.2
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date November 15, 2020
Est. completion date March 15, 2021

Study information

Verified date October 2020
Source Abionic SA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 15, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years and older
Eligibility Inclusion Criteria:

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:

1. 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.

2. Male or female, = 6 years of age.

3. 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:

1. 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.

2. Male or female, = 6 years of age.

3. 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 Criteria:

Patients must not meet any exclusion criteria below to be eligible for participation:

1. Patient participating in another study that may influence test results.

2. 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 a for the treatment of HPV is allowed), anti-IgE therapy (approved or investigational) or treated with systemic chemotherapy.

3. On-going allergen immunotherapy or prior allergen immunotherapy within the prior 3 years.

4. Patient with a history of cancer, autoimmune, or immune deficiency disease.

5. Patient suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood test.

6. Known severe allergic reaction to any of the IVD CAPSULE Allergic Asthma panel allergen components

Study Design


Intervention

Device:
Blood Collection
K3-EDTA venous whole blood 9 mL 1 venous draw

Locations

Country Name City State
United States Johns Hopkins Baltimore Maryland
United States Johns Hopkins University, Baltimore Baltimore Maryland
United States The Bernstein Clinical Research Center Cincinnati Cincinnati Ohio
United States Creticos Research Group, LLC Crownsville Maryland
United States George Washington University, Washington DC Washington District of Columbia

Sponsors (3)

Lead Sponsor Collaborator
Abionic SA Johns Hopkins University, NAMSA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Determination of Positive Predictive Value (PPV), Negative Predictive Value (NPV), Concordance and study prevalence of allergen sensitization. Presentation of Positive Predictive Value (PPV), Negative Predictive Value (NPV), Concordance and study prevalence of allergen sensitization based of the classification of 40 subjects for each allergen. Day 1
Primary Sensitivity and Specificity of the abioSCOPE The primary objective will be evaluated by estimating the Sensitivity and Specificity of the abioSCOPE to detect sensitization to each of the five allergens or group of allergens. The estimates will be accompanied by 95% Clopper-Pearson Confidence Intervals. The acceptance criteria will be compared to the lower bound of the 95% confidence interval. The ability of the abioSCOPE to detect sensitization to each allergen will be considered acceptable if both the sensitivity and specificity of the allergen meet both performance goals. Day 1
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