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Association of Periostin Levels and Chronic Sinusitis

This study has been withdrawn prior to enrollment.
(Unable to recruit/enroll subjects for study.)
Information provided by (Responsible Party):
John Steinke, University of Virginia Identifier:
First received: February 20, 2014
Last updated: May 1, 2017
Last verified: May 2017
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
Sinusitis 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 John Steinke, University of Virginia:

Primary Outcome Measures:
  • Difference in circulating serum periostin levels pre and post sinus surgery [ Time Frame: 10-15 weeks ]
    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

Enrollment: 0
Study Start Date: September 2014
Study Completion Date: October 2016
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   (Adult)
Sexes Eligible for Study:   All
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

United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
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: May 1, 2017

Keywords provided by John Steinke, University of Virginia:
Chronic sinusitis
Nasal Polyps

Additional relevant MeSH terms:
Nasal Polyps
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes processed this record on September 19, 2017