IL-38 Evaluation as a Biomarker in Pediatric Asthma | NCT05366491

Studies
IL-38 Evaluation as a Biomarker in Pediatric Asthma

NCT05366491

Sponsor

Cairo University

Status

Completed

Last Update Posted

May 12, 2022Actual

Enrollment

103Actual

Phase

Not Applicable

Conditions

Bronchial Asthma

Interventions

Il-38 serum level

Countries

Egypt

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

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Jan 12, 2021Actual

Completion Date

Apr 15, 2021Actual

First Submitted Date

May 5, 2022

First Submission Date that Met QC Criteria

May 5, 2022

First Posted Date

May 9, 2022Actual

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

May 8, 2022

Last Update Posted Date

May 12, 2022Actual

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 aim of this study is to investigate the associations between serum IL-38 levels and different variables of asthma in children such as laboratory variables, pulmonary function test results, the diagnosis of asthma, and in correlation with disease severity.

Detailed Description

Not provided

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

103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bronchial asthma patients	Active Comparator	patients diagnosed with bronchial asthma	Diagnostic Test: Il-38 serum level
healthy controls	Active Comparator	healthy subjects with age and sex matched to bronchial asthma patients	Diagnostic Test: Il-38 serum level

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Il-38 serum level	Diagnostic Test	measurement of serum levels of IL-38	bronchial asthma patients healthy controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
serum IL-38 levels	Measurement of Interleukin 38 in sera of all study subjects by ELISA	within 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients fulfilled the criteria of the Global Initiative for Asthma (GINA)
Age group:6-14 years

Exclusion Criteria:

Malignancy
Chronic inflammatory diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Asmaa Kamal, Ass prof	Assistant professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asmaa Kamal		Cairo		11562	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided