A Comparison of microRNA Samples in Patients With Nasal P... | NCT01631773

Status Module

Record Verification Date

Oct 2014

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 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Jun 27, 2012

First Submission Date that Met QC Criteria

Jun 27, 2012

First Posted Date

Jun 29, 2012Estimated

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

Oct 6, 2014

Last Update Posted Date

Oct 7, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

We hypothesize that the miRNA expression in subjects with nasal polyps and Aspirin-exacerbated respiratory disease (AERD) differs from the miRNA expressed in subjects with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD).

Detailed Description

Nasal epithelial tissue will be collected from the inferior nasal turbinates of ten subjects with nasal polyps and AERD disease and from the inferior turbinates of ten subjects with nasal polyps but without AERD. A rhinoprobe™ will be used to collect this epithelial tissue. These samples will be analyzed by miRNA assay to determine if there is a difference in mircroRNA expression between the two subject groups.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
subjects w/ Nasal polyps & AERD disease		subjects with nasal polyps and Aspirin-exacerbated respiratory disease (AERD) disease	Genetic: microRNA
subjects w/ nasal polyps without AERD		subjects with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD)	Genetic: microRNA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
microRNA	Genetic	Biological samples will be taken from subjects w/ Nasal polyps & AERD disease and subjects w/ nasal polyps without AERD. MicroRNA will be analyzed to compare genetic similarities and differences between the two study groups.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positibe Group: 2 fold or greater will be identified as differntially expressed MiRNA.	5 total groups	No time frame noted
Negative Group: MiRNAs are absent from both groups	5 total groups	No time frame noted

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages eligible for study: 18 to 70 years
Genders eligible for study: male and female
Signed and dated written informed consent is obtained prior to study
Subjects have a physician diagnosis of nasal polyps without AERD or physician diagnosis of nasal polyps with AERD. The diagnosis of aspirin sensitive asthma must be present for a minimum of three months. If the medical history is indeterminate either an aspirin challenge will be required to confirm or rule out the diagnosis. An aspirin challenge is a protocol that can safely be performed as an out patient procedure with close supervision.

Exclusion Criteria:

Pregnant and/or lactating females.
Current tobacco use.
Severe psychiatric illness.
Current illicit substance use or dependence and/or abuse of alcohol.
Primary or secondary immunodeficiency.
Any clinically significant uncontrolled medical condition that would put the patient at risk.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

This study will be a prospective study design with a target sample size of 20. The objective of conducting it as a prospective study is to confirm that the sampling procedures and analysis methodology work as expected before attempting a larger study. We propose to have 10 study participants with nasal polyps but without AERD and 10 study participants with nasal polyps and AERD. If the results of this study are promising, larger studies with sufficient power for statistical analysis will be considered.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dennis Ledford, MD	Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
USF Division of Allergy and Clinical Immunology Clinical Research Unit		Tampa	Florida	33613	United States

Description

ID	Term
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases
D011127	Polyps
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D016372	RNA, Antisense
D016375	Antisense Elements (Genetics)
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012313	RNA
D009696	Nucleic Acids
D058727	RNA, Small Untranslated
D022661	RNA, Untranslated