Allergen-mediated IgE AllergyHYCORNCT03969862
Validation Study of NOVEOS® System (HYCOR)
An observational study of Allergen-mediated IgE Allergy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Background : The NOVEOS® method is a chemiluminescent immunoassay used to provide quantitative detection of total IgE and allergen-specific IgE antibodies in human serum. The IgE antibody assay has an essential place in the diagnosis of mediated IgE allergies. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Allergen-mediated IgE Allergy
- What is being tested?
- NOVEOS® system
- Type of treatment
- Medical device
- How many people
- 536 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2019to 10 Mar 2020
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient consulting in our allergy unit for a suspicion of allergy (respiratory, food, drug, hymenoptera venoms)
Who may be able to join
None listed.
Who cannot join
- Patient refusing to take part in the study
- Patient participated in another study that may influence test results
- The patient is in an exclusion period determined by a previous study
- The patient is under the protection of justice, under guardianship or under curatorship
- Patient under antihistaminic H1 treatment preventing the achievement of Prick-tests
- The patient is pregnant
Show all 9Show fewer
- The patient is breastfeeding
- The patient has a history of tumor, autoimmune, or immune deficiency pathology
- The patient suffers from a hematological pathology (coagulation disorders, anemia) that could interfere with the blood test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation Study of Noveos® System as a Diagnostic Tools for Allergy
Background : The NOVEOS® method is a chemiluminescent immunoassay used to provide quantitative detection of total IgE and allergen-specific IgE antibodies in human serum.
The IgE antibody assay has an essential place in the diagnosis of mediated IgE allergies.
Read more
This system could become an alternative to the techniques used today. NOVEOS® uses a quick and convenient method to give results concerning the patient's sensitization profile towards allergens. The volume required for the assays is 4 μl (against more than 100 μl for current techniques), which is particularly important in pediatric and geriatric populations where it may be more difficult to take larger samples.
NOVEOS® also brings true autonomy. In fact, the incorporated reagents provide sufficient capacity for 8 hours of continuous testing.
Objective: Validate the NOVEOS® system as an allergy diagnostic tool, by estimating the sensitivity and specificity of the NOVEOS® assays compared to the gold standard diagnostic represented by the clinical history and PT positive, for a panel of 20 allergens
Methods: This is a validation study of a new immunoassay method (Système NOVEOS®).
The study includes :
- A preliminary phase to familiarize the team with the use of the NOVEOS® system. It is planned to analyze its technical characteristics: the precision, the sensitivity. Eight allergens will be tested, on a cohort of 136 patients
- A validation study of the technique as a diagnostic tool for allergy (sensitivity and specificity compared to the gold standard represented by clinical history and positive PT) and comparison between the new technique and the ImmunoCap® system. Twenty allergens will be tested prospectively, each on 50 cases and 10 controls. A single patient may be both a case for an allergen and a witness for another. For rare allergies, the blood database of the Allergy Service will be used, and affected patients will be contacted to request their non-opposition.
- Conditions
- Allergen-mediated IgE Allergy
- Being tested
- NOVEOS® system
- Keywords
- Allergy diagnostic tool, Specific IgE assays, Allergens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVEOS® systemDevice
The NOVEOS® System is a fully automated, high-throughput immunoassay platform that uses magnetic microbeads as a solid phase.
This is a partially closed system that is primarily intended for the determination of specific IgE with NOVEOS® Hycor allergens. It has the CE mark.
| Study group | Role | What they receive |
|---|---|---|
| Patient with an allergen-mediated IgE allergy | Patients with a clinical history consistent with an allergen-mediated IgE allergy \& with a sensitization demonstrated by a positive Prick-Test for the allergen source tested Receives: Device: NOVEOS® system | |
| Patient without an allergen-mediated IgE allergy | Patient without a clinical history compatible with an IgE allergy-mediated allergy and without PT sensitization to be allergen Receives: Device: NOVEOS® system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the NOVEOS® assay compared to the gold standard diagnosis.
In order to validate the NOVEOS® system as an allergy diagnostic tool, We have to estimate the sensitivity and specificity of the NOVEOS® assays compared to the gold standard diagnostic represented by the clinical history and Prick Test positive, for a panel of 20 allergens.
Measured: 24 months
Secondary outcomes (2)
Specific IgE assessed by NOVEOS®
The serum-specific IgE assay is an in vitro assay of IgE antibodies that are able to bind specifically to their allergen.
Today, there are techniques that allow the assay of both the IgE reactivity against sources of allergens, but also against the different allergenic components.
The results of the NOVEOS® method will be considered acceptable according to the following criteria:
- Total agreement ratio of sample recovery ≥ 0.8
- Linear Regression / Correlation between the 2 techniques, R ≥ 0.8
Measured: 24 months
Specific IgE assessed by Thermo-Fisher ImmunoCAP®
The serum-specific IgE assay is an in vitro assay of IgE antibodies that are able to bind specifically to their allergen.
Today, there are techniques that allow the assay of both the IgE reactivity against sources of allergens, but also against the different allergenic components. There are already commercially available, validated and standardized methods; the most used is the Thermo-Fisher ImmunoCAP® (capable of detecting specific IgE amounts> 0.1 kUA / L).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start4 Dec 2019
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Why it stopped: Covid-19 sanitary crisis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergen-mediated IgE AllergyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Hycor Biomedical
- Responsible party
- Sponsor
- Investigators
- Pascal DEMOLY, MD,PHD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969862
- Sponsor's protocol ID
- 7572
- Acronym
- HYCOR
- Status last verified
- Jun 2021
- First submitted
- 28 May 2019
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of Noveos® System as a Diagnostic Tools for Allergy
- ClinicalTrials.gov ID
- NCT03969862
- Acronym / sponsor ID
- HYCOR / 7572
- Conditions
- Allergen-mediated IgE Allergy
- Keywords
- Allergy diagnostic tool, Specific IgE assays, Allergens
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Covid-19 sanitary crisis
- Enrolment
- 536 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Hycor Biomedical
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 31 May 2019 (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.
Background : The NOVEOS® method is a chemiluminescent immunoassay used to provide quantitative detection of total IgE and allergen-specific IgE antibodies in human serum.
The IgE antibody assay has an essential place in the diagnosis of mediated IgE allergies.
This system could become an alternative to the techniques used today. NOVEOS® uses a quick and convenient method to give results concerning the patient's sensitization profile towards allergens. The volume required for the assays is 4 μl (against more than 100 μl for current techniques), which is particularly important in pediatric and geriatric populations where it may be more difficult to take larger samples.
NOVEOS® also brings true autonomy. In fact, the incorporated reagents provide sufficient capacity for 8 hours of continuous testing.
Objective: Validate the NOVEOS® system as an allergy diagnostic tool, by estimating the sensitivity and specificity of the NOVEOS® assays compared to the gold standard diagnostic represented by the clinical history and PT positive, for a panel of 20 allergens
Methods: This is a validation study of a new immunoassay method (Système NOVEOS®).
The study includes :
- A preliminary phase to familiarize the team with the use of the NOVEOS® system. It is planned to analyze its technical characteristics: the precision, the sensitivity. Eight allergens will be tested, on a cohort of 136 patients
- A validation study of the technique as a diagnostic tool for allergy (sensitivity and specificity compared to the gold standard represented by clinical history and positive PT) and comparison between the new technique and the ImmunoCap® system. Twenty allergens will be tested prospectively, each on 50 cases and 10 controls. A single patient may be both a case for an allergen and a witness for another. For rare allergies, the blood database of the Allergy Service will be used, and affected patients will be contacted to request their non-opposition.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with an allergen-mediated IgE allergy | – | Device: NOVEOS® systemPatients with a clinical history consistent with an allergen-mediated IgE allergy \& with a sensitization demonstrated by a positive Prick-Test for the allergen source tested |
| Patient without an allergen-mediated IgE allergy | – | Device: NOVEOS® systemPatient without a clinical history compatible with an IgE allergy-mediated allergy and without PT sensitization to be allergen |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient consulting in our allergy unit for a suspicion of allergy (respiratory, food, drug, hymenoptera venoms)
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Patient refusing to take part in the study
- Patient participated in another study that may influence test results
- The patient is in an exclusion period determined by a previous study
- The patient is under the protection of justice, under guardianship or under curatorship
- Patient under antihistaminic H1 treatment preventing the achievement of Prick-tests
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 |
|---|---|---|
| NOVEOS® systemThe NOVEOS® System is a fully automated, high-throughput immunoassay platform that uses magnetic microbeads as a solid phase. This is a partially closed system that is primarily intended for the determination of specific IgE with NOVEOS® Hycor allergens. It has the CE mark. | Device | Patient with an allergen-mediated IgE allergy, Patient without an allergen-mediated IgE allergy |
Primary outcome
Sensitivity and specificity of the NOVEOS® assay compared to the gold standard diagnosis.
Time frame: 24 months
In order to validate the NOVEOS® system as an allergy diagnostic tool, We have to estimate the sensitivity and specificity of the NOVEOS® assays compared to the gold standard diagnostic represented by the clinical history and Prick Test positive, for a panel of 20 allergens.
2 secondary outcomes
Specific IgE assessed by NOVEOS®
Time frame: 24 months
Specific IgE assessed by Thermo-Fisher ImmunoCAP®
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Covid-19 sanitary crisis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Allergen-mediated IgE Allergy
Recruiting
Recombinant Tropomyosin- and Hemocyanin-Specific IgE in Children With Suspected Shrimp Allergy
Food Hypersensitivity, Shellfish Allergy
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.
Pascal DEMOLY, MD,PHD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergen-mediated IgE Allergy, run by University Hospital, Montpellier at 1 site in France.
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 0 inclusion and 9 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: stopped early, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 stopped early (reason given: Covid-19 sanitary crisis). Results are not available in the source record.
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 NOVEOS® assay compared to the gold standard diagnosis. (time frame: 24 months). 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 18 Jun 2021.