AllergyNCT06167564
Allergy Diagnostic Test Based on Microchip Technology
A study testing Routine allergy tests and Newly developed microarray-based diagnostic test system in people with Allergy and Allergy;Food, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial summary
The purpose of this study is to develop a microarray-based diagnostic test system for the determination of allergen specific IgE in human blood serum. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Allergy, Allergy;Food, Allergy Pollen
- What is being tested?
- Routine allergy tests and Newly developed microarray-based diagnostic test system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type I allergy (food, drug, pollen)
- The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
- Written informed consent
Who cannot join
- Acute or chronic diseases in the stage of decompensation (except allergy)
- Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
- Patients who are pregnant, breastfeeding
- Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
- Patients are unable or unwilling to give written informed consent and / or follow research procedures
- Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, 220072
About this study
Official title: Development of a Diagnostic Test System Based on Microchip Technology for the Detection of IgE-dependent Allergic Reactions
The purpose of this study is to develop a microarray-based diagnostic test system for the determination of allergen specific IgE in human blood serum.
Read the detailed description
The purpose of this study is to develop a microarray-based diagnostic test system for the determination of allergen specific IgE in human blood serum samples and to assess the sensitivity and specificity of the developed system.
- Conditions
- Allergy, Allergy;Food, Allergy Pollen, Allergy Drug
- Being tested
- Routine allergy tests, Newly developed microarray-based diagnostic test system
- Medical subject headings
- Hypersensitivity, Food Hypersensitivity, Rhinitis, Allergic, Seasonal, Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine allergy testsDiagnostic test
Prick test, specific IgE detection
Newly developed microarray-based diagnostic test systemDiagnostic test
Newly developed microarray-based diagnostic test system for the detection of the specific IgE
| Study group | Role | What they receive |
|---|---|---|
| Routine allergy tests | Active comparator | Routine allergy tests (prick tests, specific IgE detection) will be done to establish the sensibilization of the patient. Receives: Diagnostic Test: Routine allergy tests |
| Newly developed microarray-based diagnostic test system | Experimental | Newly developed microarray-based diagnostic test system will be used to establish the sensibilization of the patient. Receives: Diagnostic Test: Newly developed microarray-based diagnostic test system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IgE levels of the specific pollen allergens
Serum IgE levels of the specific pollen allergens will be sudied
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Group of adult participants with IgE-dependent allergic reactions. Routine blood serum IgE levels will be compared with the newly developed microarray-based diagnostic test system.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Andrei Hancharou, Dr, Study director, IBCEAntonina Osipova, Dr, Study director, IBCEEkaterina Shamova, r, Principal investigator, IBCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167564
- Sponsor's protocol ID
- IBCE_Allergytest
- Status last verified
- Dec 2023
- First submitted
- 20 Oct 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Diagnostic Test System Based on Microchip Technology for the Detection of IgE-dependent Allergic Reactions
- ClinicalTrials.gov ID
- NCT06167564
- Acronym / sponsor ID
- IBCE_Allergytest
- Conditions
- Allergy, Allergy;Food, Allergy Pollen, Allergy Drug
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Dec 2023 (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.
The purpose of this study is to develop a microarray-based diagnostic test system for the determination of allergen specific IgE in human blood serum.
Detailed description
The purpose of this study is to develop a microarray-based diagnostic test system for the determination of allergen specific IgE in human blood serum samples and to assess the sensitivity and specificity of the developed system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group of adult participants with IgE-dependent allergic reactions. Routine blood serum IgE levels will be compared with the newly developed microarray-based diagnostic test system.
| Arm | Type | Receives |
|---|---|---|
| Routine allergy tests | Active comparator | Diagnostic Test: Routine allergy testsRoutine allergy tests (prick tests, specific IgE detection) will be done to establish the sensibilization of the patient. |
| Newly developed microarray-based diagnostic test system | Experimental | Diagnostic Test: Newly developed microarray-based diagnostic test systemNewly developed microarray-based diagnostic test system will be used to establish the sensibilization of the patient. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type I allergy (food, drug, pollen)
- The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
- Written informed consent
Key exclusion criteria (6 listed)
- Acute or chronic diseases in the stage of decompensation (except allergy)
- Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
- Patients who are pregnant, breastfeeding
- Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
- Patients are unable or unwilling to give written informed consent and / or follow research procedures
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 |
|---|---|---|
| Routine allergy testsPrick test, specific IgE detection | Diagnostic test | Routine allergy tests |
| Newly developed microarray-based diagnostic test systemNewly developed microarray-based diagnostic test system for the detection of the specific IgE | Diagnostic test | Newly developed microarray-based diagnostic test system |
Primary outcome
Serum IgE levels of the specific pollen allergens
Time frame: 1 month
Serum IgE levels of the specific pollen allergens will be sudied
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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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.
Andrei Hancharou, Dr study director
IBCE
Antonina Osipova, Dr study director
IBCE
Ekaterina Shamova, r principal investigator
IBCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine allergy tests and Newly developed microarray-based diagnostic test system in people with Allergy and Allergy;Food, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Dec 2023. 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 Belarus. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrei Hancharou, Dr (+375296248972, andrei.hancharou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IgE levels of the specific pollen allergens (time frame: 1 month). 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 12 Dec 2023.