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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-04-30

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.

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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.

Conditions

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Maxillary Sinusitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery

Group Type ACTIVE_COMPARATOR

Specimen collection

Intervention Type 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.

2

10 patients without sinus disease will have three specimens collected from the maxillary sinus during surgery.

Group Type PLACEBO_COMPARATOR

Specimen collection

Intervention Type PROCEDURE

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.

Interventions

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Specimen collection

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.

Intervention Type PROCEDURE

Specimen collection

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

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