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Completed

NCT Number: NCT00683371

Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, Dept of Otolaryngology-HNS

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(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

Exclusion criteria

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

Treatment and study plan

Specimen Collection

Procedure

10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery. The sinus mucosa, sinus mucus and a saline lavage will be collected. The three samples will then be analyzed with microarrays looking for bacteria, fungi, and viruses.

Primary outcomes

  1. Microbial community profiling using the PhyloChip, MycoChip, and ViroChip will yield vast quantities of data to be reduced in dimensions for interpretation. Pathogens detected in the nasal mucus of patients with CRS will be compared to healthy controls.

    Time frame: Immediate Preoperative period.

Secondary outcomes

  1. The presence or absence of a given microorganism will be compared to previously published data obtained using either traditional culture methods or other genomic methods.

    Time frame: Immediate preoperative period

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 23, 2008
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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