Allergy Diagnostic Test Based on Microchip Technology

NCT ID: NCT06167564

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Allergy Allergy;Food Allergy Pollen Allergy Drug

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Routine allergy tests

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

Group Type ACTIVE_COMPARATOR

Routine allergy tests

Intervention Type DIAGNOSTIC_TEST

Prick test, specific IgE detection

Newly developed microarray-based diagnostic test system

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

Group Type EXPERIMENTAL

Newly developed microarray-based diagnostic test system

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Routine allergy tests

Prick test, specific IgE detection

Intervention Type DIAGNOSTIC_TEST

Newly developed microarray-based diagnostic test system

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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 informed consent

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrei Hancharou, Dr

Role: STUDY_DIRECTOR

IBCE

Antonina Osipova, Dr

Role: STUDY_DIRECTOR

IBCE

Ekaterina Shamova, r

Role: PRINCIPAL_INVESTIGATOR

IBCE

Locations

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Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Minsk, , Belarus

Site Status

Countries

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Belarus

Central Contacts

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Andrei Hancharou, Dr

Role: CONTACT

Phone: +375296248972

Email: [email protected]

Other Identifiers

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IBCE_Allergytest

Identifier Type: -

Identifier Source: org_study_id