Association of Periostin Levels and Chronic Sinusitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Virginia
Information provided by (Responsible Party):
John Steinke, University of Virginia Identifier:
First received: February 20, 2014
Last updated: December 4, 2014
Last verified: December 2014
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.

Condition Intervention
Nasal Polyps
Other: Blood draw

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Association of Periostin Levels and Chronic Sinusitis

Resource links provided by NLM:

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Difference in circulating serum periostin levels pre and post sinus surgery [ Time Frame: 10-15 weeks ] [ Designated as safety issue: No ]
    Serum collected prior to and following sinus surgery will be analyzed for concentrations of the protein periostin.

Biospecimen Retention:   Samples Without DNA
Serum and paraffin embedded nasal polyp tissue samples

Estimated Enrollment: 30
Study Start Date: September 2014
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects who require sinus surgery Other: Blood draw


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who are recommended for sinus surgery as part of their care who self report no asthma.

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02071667

Contact: John Steinke 434-982-3270

United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: John W Steinke, PhD         
Sponsors and Collaborators
University of Virginia
  More Information

Responsible Party: John Steinke, Associate Professor, University of Virginia Identifier: NCT02071667     History of Changes
Other Study ID Numbers: 17123 
Study First Received: February 20, 2014
Last Updated: December 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Chronic sinusitis
Nasal Polyps

Additional relevant MeSH terms:
Chronic Disease
Nasal Polyps
Disease Attributes
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on May 23, 2016