Allergy Diagnostic Test Based on Microchip Technology

NCT06167564 | Unknown

• 1 other identifier: IBCE_Allergytest
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergy; Allergy;Food; Allergy Pollen; Allergy Drug

Outcome Measures

Primary Outcomes (1)

• Serum IgE levels of the specific pollen allergens

  Serum IgE levels of the specific pollen allergens will be sudied

  1 month

Study Arms (2)

Routine allergy tests

ACTIVE COMPARATOR

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

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.

Diagnostic Test: Newly developed microarray-based diagnostic test system

Interventions

Routine allergy tests DIAGNOSTIC_TEST

Prick test, specific IgE detection

Routine allergy tests

Newly developed microarray-based diagnostic test system DIAGNOSTIC_TEST

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

Newly developed microarray-based diagnostic test system

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus: lead

Study Sites (1)

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

Minsk, 220072, Belarus

Location

MeSH Terms

Conditions

Hypersensitivity; Food Hypersensitivity; Rhinitis, Allergic, Seasonal; Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases; Hypersensitivity, Immediate; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Andrei Hancharou, Dr

  IBCE

  STUDY DIRECTOR

• Antonina Osipova, Dr

  IBCE

  STUDY DIRECTOR

• Ekaterina Shamova, r

  IBCE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrei Hancharou, Dr

CONTACT

+375296248972; andrei.hancharou@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: December 12, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

BE (1)