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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Maxillary Sinusitis

Treatments: Procedure: Specimen collection

Study type: Interventional

Funder types: Other

Identifiers

NCT00683371

H43796-31316-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

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

Treatment:

Procedure: Specimen collection

Procedure: Specimen collection

2

Placebo Comparator group

Description:

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

Treatment:

Procedure: Specimen collection

Procedure: Specimen collection