Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis - Full Text View

Purpose

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	Intervention
Maxillary Sinusitis	Procedure: Specimen collection

MedlinePlus related topics:

Molds Sinusitis

ChemIDplus related topics:

Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Single Blind (Investigator), Parallel Assignment

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

Further study details as provided by University of California, San Francisco:

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. [ Time Frame: Immediate Preoperative period. ] [ Designated as safety issue: No ]

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. [ Time Frame: Immediate preoperative period ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Placebo Comparator 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683371

Contacts


Contact: Wendy Ma	415-353-2870	wma@ohns.ucsf.edu

Contact: Andrew Goldberg, MD, MSCE	415-353-2757	agoldberg@ohns.ucsf.edu

Locations


United States, California
	University of California, San Francisco, Dept of Otolaryngology-HNS	Recruiting
	San Francisco, California, United States, 94143
	Contact: Wendy Ma 415-353-2870 wma@ohns.ucsf.edu
	Contact: Andrew Goldberg, MD, MSCE 415-353-2757 agoldberg@ohns.ucsf.edu
	Principal Investigator: Andrew Goldberg, MD, MSCE

Sponsors and Collaborators

University of California, San Francisco

Investigators


Principal Investigator:	Andrew Goldberg, MD, MSCE	University of California, San Francisco

More Information

Responsible Party:	University of California, San Francisco, Department of Otolaryngology-HNS ( Andrew N. Goldberg, MD, MSCE )
Study ID Numbers:	H43796-31316-01
First Received:	May 21, 2008
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00683371
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

Chronic Rhinosinusitis

Sinus Disease

Allergy

Maxillary Sinus

Microarray

Study placed in the following topic categories:

Hypersensitivity

Otorhinolaryngologic Diseases

Respiratory Tract Infections

Respiratory Tract Diseases

Hypersensitivity, Immediate

Maxillary Sinusitis

Sinusitis

Additional relevant MeSH terms:

Paranasal Sinus Diseases

Nose Diseases

ClinicalTrials.gov processed this record on August 20, 2008

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00683371