Development and Validation of a Serum Biomarker for the D... | NCT04377958

Studies
Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma

NCT04377958

Sponsor

KU Leuven

Status

Completed

Last Update Posted

May 8, 2020Actual

Enrollment

117Actual

Phase

Not Applicable

Conditions

Asthma
Biomarkers

Interventions

Serum biomarker testing

Countries

Not provided

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 2020

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

Dec 2016Actual

Primary Completion Date

Oct 2017Actual

Completion Date

May 2020Actual

First Submitted Date

May 4, 2020

First Submission Date that Met QC Criteria

May 4, 2020

First Posted Date

May 7, 2020Actual

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 6, 2020

Last Update Posted Date

May 8, 2020Actual

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

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

117Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Asthmatics	Other	Asthmatic group from which serum samples will be collected for analysis	Diagnostic Test: Serum biomarker testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serum biomarker testing	Diagnostic Test	Serum and sputum samples will be collected and biomarkers will be evaluated using ELISA	Asthmatics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum calprotectin	Serum Calprotectin (pg/ml) will be measured in serum samples using a U-plex assay	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Sputum calprotectin	Sputum Calprotectin (pg/ml) will be measured in sputum samples using a U-plex assay	Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 - 65 years
physician-diagnosed asthma

Exclusion Criteria:

No clear asthma phenotype
Presence of other pulmonary diseases (Chronic obstructive pulmonary disease, alfa-1-antitrypsine deficiency emphysema, Immunoglobulin E deficiency, allergic bronchopulmonary aspergillosis)
> 15 pack years
No sputum available
Respiratory infection
Other inflammatory diseases (Rheumatoid Arthritis, Colitis Ulcerosa)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Lieven Dupont	UZ Leuven	Principal Investigator

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