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

Not Applicable

Completed

• Conditions: Maxillary Sinusitis
• Interventions: Procedure: Specimen collection

• Registration Number: NCT00683371
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-04-30
• Study Completion: 2008-04-30
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-22
• Study First Posted: 2008-05-23
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-30
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Specimen collection	10 patients without sinus disease will have three specimens collected from the maxillary sinus during surgery.
1	Specimen collection	10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery

Primary Outcome Measures

Name	Time	Method
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.	Immediate Preoperative period.

Secondary Outcome Measures

Name	Time	Method
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.	Immediate preoperative period

Trial Locations

Locations (1)

University of California, San Francisco, Dept of Otolaryngology-HNS; 🇺🇸 San Francisco, California, United States