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Trial record 2 of 67 for:    Open Studies | "Sinusitis"

Association of Periostin Levels and Chronic Sinusitis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by University of Virginia
Sponsor:
Information provided by (Responsible Party):
John Steinke, University of Virginia
ClinicalTrials.gov Identifier:
NCT02071667
First received: February 20, 2014
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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 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: February 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects who require sinus surgery Other: Blood draw

  Eligibility

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.

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)
  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 ClinicalTrials.gov identifier: NCT02071667

Contacts
Contact: John Steinke 434-982-3270 js3ch@virginia.edu

Locations
United States, Virginia
University of Virginia Not yet recruiting
Charlottesville, Virginia, United States, 22908
Contact: John Steinke         
Sponsors and Collaborators
University of Virginia
  More Information

No publications provided

Responsible Party: John Steinke, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT02071667     History of Changes
Other Study ID Numbers: 17123
Study First Received: February 20, 2014
Last Updated: February 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Chronic sinusitis
Nasal Polyps

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

ClinicalTrials.gov processed this record on November 24, 2014