ClinicalTrials.gov
ClinicalTrials.gov Menu

Association of Periostin Levels and Chronic Sinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02071667
Recruitment Status : Withdrawn (Unable to recruit/enroll subjects for study.)
First Posted : February 26, 2014
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
John Steinke, University of Virginia

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.

Condition or disease Intervention/treatment
Sinusitis Nasal Polyps Other: Blood draw

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Association of Periostin Levels and Chronic Sinusitis
Study Start Date : September 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Group/Cohort Intervention/treatment
Subjects who require sinus surgery Other: Blood draw



Primary Outcome Measures :
  1. 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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071667


Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia

Responsible Party: John Steinke, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT02071667     History of Changes
Other Study ID Numbers: 17123
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

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

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes