Allergy Diagnostic Test Based on Microchip Technology | NCT06167564

Studies
Allergy Diagnostic Test Based on Microchip Technology

NCT06167564

Sponsor

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

Status

Unknown status

Last Update Posted

Dec 12, 2023Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Allergy
Allergy;Food
Allergy Pollen
Allergy Drug

Interventions

Routine allergy tests
Newly developed microarray-based diagnostic test system

Countries

Belarus

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Estimated

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Oct 20, 2023

First Submission Date that Met QC Criteria

Dec 4, 2023

First Posted Date

Dec 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2023

Last Update Posted Date

Dec 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Routine allergy tests	Diagnostic Test	Prick test, specific IgE detection	Routine allergy tests

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum IgE levels of the specific pollen allergens	Serum IgE levels of the specific pollen allergens will be sudied	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrei Hancharou, Dr	Contact	+375296248972		andrei.hancharou@gmail.com

Overall Officials

Name	Affiliation	Role
Andrei Hancharou, Dr	IBCE	Study Director
Antonina Osipova, Dr	IBCE	Study Director
Ekaterina Shamova, r

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus		Minsk		220072	Belarus

Condition Browse Module

MeSH Terms

ID	Term
D006967	Hypersensitivity
D005512	Food Hypersensitivity
D006255	Rhinitis, Allergic, Seasonal
D004342	Drug Hypersensitivity

Ancestor Terms

ID	Term
D007154	Immune System Diseases
D006969	Hypersensitivity, Immediate
D065631	Rhinitis, Allergic
D012220	Rhinitis

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Browse Branches

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