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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Maxillary Sinusitis

Intervention / Treatment
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* Procedure: Specimen collection
* Procedure: Specimen collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery | Procedure: Specimen collection<br>* 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.<br>|
| Placebo Comparator: 2<br>10 patients without sinus disease will have three specimens collected from the maxillary sinus during surgery. | Procedure: Specimen collection<br>* 10 patients without sinus disease 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Rhinosinusitis, Sinus Disease, Allergy, Maxillary Sinus, Microarray