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NCT06167564 Clinical Trial

Allergy Diagnostic Test Based on Microchip Technology

Allergy Clinical Trial

Official title:
Development of a Diagnostic Test System Based on Microchip Technology for the Detection of IgE-dependent Allergic Reactions

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06167564
Other study ID # IBCE_Allergytest
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date December 31, 2024

Study information
Verified date December 2023
Source Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Contact Andrei Hancharou, Dr
Phone +375296248972
Email andrei.hancharou@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 400
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Routine allergy tests
Prick test, specific IgE detection
• Newly developed microarray-based diagnostic test system
Newly developed microarray-based diagnostic test system for the detection of the specific IgE

Locations
Country Name City State
Belarus Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Minsk

Sponsors (1)
Lead Sponsor Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Country where clinical trial is conducted

Belarus, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum IgE levels of the specific pollen allergens Serum IgE levels of the specific pollen allergens will be sudied 1 month
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