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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Recruitment Status : Withdrawn (Unable to recruit/enroll subjects for study.)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

Tracking Information
First Submitted Date February 20, 2014
First Posted Date February 26, 2014
Last Update Posted Date May 4, 2017
Study Start Date September 2014
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 21, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Association of Periostin Levels and Chronic Sinusitis
Official Title Association of Periostin Levels and Chronic Sinusitis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum and paraffin embedded nasal polyp tissue samples
Sampling Method Non-Probability Sample
Study Population Subjects who are recommended for sinus surgery as part of their care who self report no asthma.
Condition
  • Sinusitis
  • Nasal Polyps
Intervention Other: Blood draw
Study Groups/Cohorts Subjects who require sinus surgery
Intervention: Other: Blood draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: May 1, 2017)
0
Original Estimated Enrollment
 (submitted: February 21, 2014)
30
Actual Study Completion Date October 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02071667
Other Study ID Numbers 17123
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party John Steinke, University of Virginia
Study Sponsor University of Virginia
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Virginia
Verification Date May 2017