Nasal Epithelium Gene Expression Profiling in Child Respi... | NCT00569361

Studies
Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease

NCT00569361

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Jun 9, 2009Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Allergic Rhinitis

Interventions

Collection of nasal epithelial cells

Countries

France

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

Jun 2009

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

Nov 2004

Primary Completion Date

Not provided

Completion Date

Oct 2005Actual

First Submitted Date

Dec 6, 2007

First Submission Date that Met QC Criteria

Dec 6, 2007

First Posted Date

Dec 7, 2007Estimated

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

Jun 8, 2009

Last Update Posted Date

Jun 9, 2009Estimated

Name	Class
ADPHUN, FRM	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Using a human pangenomic microarray, the researchers established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct groups:

allergic rhinitis to dust mite (AR) isolated (n=12),
AR associated with bronchial hyperreactivity (n=12),
AR associated with asthma (n=14),
control (n=14).

Detailed Description

Context: Asthma is the most frequent chronic disease in childhood. Allergic rhinitis has been described as a risk factor to develop asthma. The objective of the study was to evaluate the contribution of the respiratory epithelium to development of allergic rhinitis and asthma and to identify the molecular mechanisms driving rhinitis toward asthma.

Methods: Using a human pangenomic microarray, we established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct children 2 to 18 years of age groups:

allergic rhinitis to dust mite (AR) isolated (n=12),
AR associated with bronchial hyperreactivity (n=12),
AR associated with asthma (n=14),
control (n=14).

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Other	Collection of nasal epithelial cells by brushing	Procedure: Collection of nasal epithelial cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collection of nasal epithelial cells	Procedure	Collection of nasal epithelial cells by brushing	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Transcriptome analysis: genes statistically modulated between groups, predictive biomarkers allowing correct classification of groups		At the sample time

Secondary Outcomes

Measure	Description	Time Frame
Validation with other techniques: Q-PCR		At the sample time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients:

Patients between 6 and 17 years old
Patients with allergic rhinitis

Witness:

Patients between 6 and 17 years old
Patients without allergic rhinitis and asthma

Exclusion Criteria:

Rhino-bronchitis infection dated from less than 15 days
Patients younger than 6 or older than 17 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Albertini, Professor	Department of Pediatrics of Nice University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics, Nice University Hospital		Nice		06000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22005912	Derived	Giovannini-Chami L, Marcet B, Moreilhon C, Chevalier B, Illie MI, Lebrigand K, Robbe-Sermesant K, Bourrier T, Michiels JF, Mari B, Crenesse D, Hofman P, de Blic J, Castillo L, Albertini M, Barbry P. Distinct epithelial gene expression phenotypes in childhood respiratory allergy. Eur Respir J. 2012 May;39(5):1197-205. doi: 10.1183/09031936.00070511. Epub 2011 Oct 17.

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity