AllergyNCT04442932
abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies
An observational study of Allergy and Allergic Asthma, run by Abionic SA at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergy, Allergic Asthma, Allergy to Cats
- What is being tested?
- Blood Collection
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Nov 2020to 15 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: • Per test, a minimum of 40 atopic subjects for a given allergy and a total of at least 100 non-atopic subjects (). To ensure that sufficient subjects with valid results are enrolled, the atopic enrollment goal per allergy is approximately 50 subjects. For each allergen, approximately 20% of the samples must be in the range of 0.70 to 3.5 IUA/mL and the remainder must cover a measuring range that is representative of the target population. Results from a single positive subject can be used in the analyses of more than one allergen if the subject is sensitized for more than one allergen.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University, Baltimore
Baltimore, Maryland, 21215
Johns Hopkins
Baltimore, Maryland, 21287
The Bernstein Clinical Research Center Cincinnati
Cincinnati, Ohio, 45231
Creticos Research Group, LLC
Crownsville, Maryland, 20132
George Washington University, Washington DC
Washington D.C., District of Columbia, 20037
About this study
Official title: Validation of the abioSCOPE Device With an IgE Test Panel: Clinical Sensitivity and Specificity Study
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.
- Conditions
- Allergy, Allergic Asthma, Allergy to Cats, Allergy to House Dust, Allergy to Dog Dander, Allergy Cockroach
- Being tested
- Blood Collection
- Keywords
- Allergy, Asthma, Point-of-Care, Immunoassay, In vitro Diagnostic, Total IgE, Specific allergy
- Medical subject headings
- Hypersensitivity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood CollectionDevice
K3-EDTA venous whole blood 9 mL 1 venous draw
| Study group | Role | What they receive |
|---|---|---|
| Interventions | Per test, a minimum of 40 atopic subjects for a given allergy and a total of at least 100 non-atopic subjects. To ensure that sufficient subjects with valid results are enrolled, the atopic enrollment goal per allergy is approximately 50 subjects. For each allergen, approximately 20% of the samples must be in the range of 0.70 to 3.5 IUA/mL and the remainder must cover a measuring range that is representative of the target population. Results from a single positive subject can be used in the analyses of more than one allergen if the subject is sensitized for more than one allergen. Receives: Device: Blood Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start15 Nov 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion15 Mar 2021 (estimated)
Why it stopped: Sponsor financial has been stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abionic SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA, Johns Hopkins University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442932
- Sponsor's protocol ID
- AB-ALL-003.2
- Status last verified
- Oct 2020
- First submitted
- 16 Jun 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the abioSCOPE Device With an IgE Test Panel: Clinical Sensitivity and Specificity Study
- ClinicalTrials.gov ID
- NCT04442932
- Acronym / sponsor ID
- AB-ALL-003.2
- Conditions
- Allergy, Allergic Asthma, Allergy to Cats, Allergy to House Dust, Allergy to Dog Dander, Allergy Cockroach
- Keywords
- Allergy, Asthma, Point-of-Care, Immunoassay, In vitro Diagnostic, Total IgE, Specific allergy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor financial has been stopped.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abionic SAIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA, Johns Hopkins University
- Study start
- 15 Nov 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 15 Mar 2021 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventions | – | Device: Blood CollectionPer test, a minimum of 40 atopic subjects for a given allergy and a total of at least 100 non-atopic subjects. To ensure that sufficient subjects with valid results are enrolled, the atopic enrollment goal per allergy is approximately 50 subjects. For each allergen, approximately 20% of the samples must be in the range of 0.70 to 3.5 IUA/mL and the remainder must cover a measuring range that is representative of the target population. Results from a single positive subject can be used in the analyses of more than one allergen if the subject is sensitized for more than one allergen. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- • Per test, a minimum of 40 atopic subjects for a given allergy and a total of at least 100 non-atopic subjects (). To ensure that sufficient subjects with valid results are enrolled, the atopic enrollment goal per allergy is approximately 50 subjects. For each allergen, approximately 20% of the samples must be in the range of 0.70 to 3.5 IUA/mL and the remainder must cover a measuring range that is representative of the target population. Results from a single positive subject can be used in the analyses of more than one allergen if the subject is sensitized for more than one allergen.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood CollectionK3-EDTA venous whole blood 9 mL 1 venous draw | Device | Interventions |
Primary outcome
Sensitivity and Specificity of the abioSCOPE
Time frame: Day 1
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy and Allergic Asthma, run by Abionic SA at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of the abioSCOPE (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.