FARE - Food Allergy Research & Education Logo

Allergy Diagnostic Test Based on Microchip Technology

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06167564
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

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

The person who is responsible for the scientific and technical direction of the entire clinical study.

Andrei Hancharou, DrAntonina Osipova, DrEkaterina Shamova, r
Principal Investigator Affiliation IBCEIBCEIBCE
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Belarus
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Allergy, Allergy;Food, Allergy Pollen, Allergy Drug
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Routine allergy tests

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

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.

Interventions

Diagnostic Test: - Routine allergy tests

Prick test, specific IgE detection

Diagnostic Test: - Newly developed microarray-based diagnostic test system

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Minsk, Belarus

Status

Address

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

Minsk, , 220072

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.