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Summary

for people ages 18 years and up (full criteria)
healthy people welcome
at San Francisco, California
study started
estimated completion:

Description

Summary

Mucosal biopsies, endoscopically-guided brush samples of mucus, and a saline lavage taken from the maxillary sinuses of ten CRS patients undergoing sinus surgery are analyzed using three microarrays in order to detect bacteria, fungi and viruses. Ten control patients with normal sinuses will have the same samples taken. The hypothesis is that bacterial, fungal, and viral communities present in the maxillary sinus of patients with CRS are significantly different from those patients with healthy sinuses, and that microorganisms identified in patients with or without CRS will differ from previously published data obtained using other techniques.

Details

Mucosal biopsies, endoscopically-guided brush samples of mucus, and a saline lavage taken from the maxillary sinuses of ten CRS patients undergoing sinus surgery are analyzed using three microarrays: 16S rRNA PhyloChip (to detect bacteria), MycoChip (to detect fungi) and ViroChip (to detect viruses). Ten control patients with normal sinuses, as assessed by CT scan and a sinusitis-specific survey, will have the same samples taken. The hypothesis is that bacterial, fungal, and viral communities present in the maxillary sinus of patients with CRS are significantly different from those patients with healthy sinuses, and that microorganisms identified in patients with or without CRS will differ from previously published data obtained using other techniques. Comparing diseased and control flora will provide insight into the relative contribution of each pathogen to CRS and may guide the development of future therapies.

Keywords

Maxillary Sinusitis Chronic Rhinosinusitis Sinus Disease Allergy Maxillary Sinus Microarray Sinusitis

Eligibility

You can join if…

Open to people ages 18 years and up

(CRS patients):

  • History of CRS as defined as symptoms (nasal discharge, nasal obstruction, facial pain and/or hyposmia) for >12 weeks despite therapy.
  • Impaired CRS-specific quality of life (SNOT-20 score >1.5).
  • Evidence of sinus disease on a CT scan (Lund MacKay score greater than or equal to 10).
  • Patients with positive skin or RAST testing to an inhalant allergen and/or aspirin hypersensitivity will be included. Evidence of atopy is not required but will be recorded, along with serum IgE levels, when available.

Inclusion Criteria (Control patients):

  • No history of CRS
  • SNOT-20 score <1.0
  • No evidence of sinus disease on preoperative imaging

You CAN'T join if...

  • Control patients with any evidence of CRS, by history, survey, or imaging criteria would be excluded.

Location

  • University of California, San Francisco, Dept of Otolaryngology-HNS
    San Francisco, California, 94143, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT00683371
Lead Scientist
Andrew Goldberg
Study Type
Interventional
Last Updated
October 30, 2017