Association of Periostin Levels and Chronic Sinusitis

NCT02071667 | Withdrawn

• 1 other identifier: 17123
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if a protein in blood, called periostin, can determine if patients have chronic sinusitis. This protein is in everyone's body, but the level of the protein may indicate certain conditions such as chronic sinusitis. The investigators are interested in testing levels of periostin to see if they are higher or lower than patients without chronic sinusitis, just as periostin is higher in patients with asthma. All patients enrolled in this study will have chronic sinusitis without asthma.

Conditions

Sinusitis; Nasal Polyps

Keywords

Chronic sinusitis; Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Difference in circulating serum periostin levels pre and post sinus surgery

  Serum collected prior to and following sinus surgery will be analyzed for concentrations of the protein periostin.

  10-15 weeks

Study Arms (1)

Subjects who require sinus surgery

Other: Blood draw

Interventions

Blood draw OTHER

Subjects who require sinus surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who are recommended for sinus surgery as part of their care who self report no asthma.

You may qualify if:

• Patients with sinus disease which requires surgical intervention
• Ability to understand and give informed consent

You may not qualify if:

• Previous diagnosis of asthma
• Positive methacholine challenge at screening
• Diagnosis of cystic fibrosis
• Concomitant use of systemic corticosteroids (except for those prescribed as part of standard pre-surgical treatment)

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and paraffin embedded nasal polyp tissue samples

MeSH Terms

Conditions

Sinusitis; Nasal Polyps

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 26, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

US (1)