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

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT00683371

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Maxillary Sinusitis	Procedure: Specimen collection Procedure: Specimen collection	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Apr 30, 2008

Actual Study Completion Date :

Apr 30, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery	Procedure: 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.
Placebo Comparator: 2 10 patients without sinus disease will have three specimens collected from the maxillary sinus during surgery.	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.

Arm

Intervention/Treatment

Active Comparator: 1

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

Procedure: 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.

Placebo Comparator: 2

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

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.