ClinicalTrials.gg
Not yet recruitingNCT06167564Updated Dec 12, 2023

Allergy Diagnostic Test Based on Microchip Technology

An interventional study of Routine allergy tests and Newly developed microarray-based diagnostic test system in Allergy, Allergy;Food and Allergy Pollen, sponsored by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus. Not yet recruiting at 1 site in Belarus. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-12.

Primary conditionRhinitis, Allergic, SeasonalRegistry: HypersensitivityReclassifiedWhy we changed it
Registry
Hypersensitivity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Rhinitis, Allergic, Seasonal
Why
  1. The study's listed conditions name Rhinitis, Allergic, Seasonal, a narrower term within Hypersensitivity.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Allergy
  • Allergy;Food
  • Allergy Pollen
  • Allergy Drug
03

In context

Rhinitis, Allergic, Seasonal Reclassified

404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.

This study's planned enrollment of 400 is above the median of 131 across 366 interventional studies indexed under Rhinitis, Allergic, Seasonal.

Browse Rhinitis, Allergic, Seasonal studies →

Lead sponsor

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus is the lead sponsor of 25 studies on the registry; 1 is open to participants now.

Compared within Rhinitis, Allergic, Seasonal, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Type I allergy (food, drug, pollen)
  • The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
  • Written

Exclusion criteria

Exclusion Criteria:

  • Acute or chronic diseases in the stage of decompensation (except allergy)
  • Chronic infectious diseases: , viral , 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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Active comparator
    Routine allergy tests

    Routine allergy tests (prick tests, specific IgE detection) will be done to establish the sensibilization of the patient.

    Diagnostic Test: Routine allergy tests

  • Experimental
    Newly developed microarray-based diagnostic test system

    Newly developed microarray-based diagnostic test system will be used to establish the sensibilization of the patient.

    Diagnostic Test: Newly developed microarray-based diagnostic test system

Interventions

  • Diagnostic testRoutine allergy tests

    Prick test, specific IgE detection

  • Diagnostic testNewly developed microarray-based diagnostic test system

    Newly developed microarray-based diagnostic test system for the detection of the specific IgE

06

What researchers measure

Primary outcomes

  1. Serum IgE levels of the specific pollen allergens

    Serum IgE levels of the specific pollen allergens will be sudied

    Time frame: 1 month

07

Study locations

1 site
  • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
    Minsk, 220072, Belarus
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06167564
Lead sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Responsible party
Sponsor
First posted
Dec 12, 2023
Start date
Jan 1, 2024 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Dec 12, 2023

Study contacts

Andrei Hancharou, Dr
Contact
andrei.hancharou@gmail.com
+375296248972
Andrei Hancharou, Dr
study director · IBCE
Antonina Osipova, Dr
study director · IBCE
Ekaterina Shamova, r
principal investigator · IBCE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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