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

Tracking Information

First Received Date ^ICMJE

May 21, 2008

Last Updated Date

February 17, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00683371 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Single Blind (Investigator), Parallel Assignment

Condition ^ICMJE

Maxillary Sinusitis

Intervention ^ICMJE

Procedure: Specimen collection

Study Arms / Comparison Groups

Active Comparator: 10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery
Placebo Comparator: 10 patients without sinus disease will have three specimens collected from the maxillary sinus during surgery.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2008

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Wendy Ma	415-353-2870	wma@ohns.ucsf.edu
Contact: Andrew Goldberg, MD, MSCE	415-353-2757	agoldberg@ohns.ucsf.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00683371

Responsible Party

Andrew N. Goldberg, MD, MSCE, University of California, San Francisco, Department of Otolaryngology-HNS

Study ID Numbers ^ICMJE

H43796-31316-01

Study Sponsor ^ICMJE

University of California, San Francisco

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Andrew Goldberg, MD, MSCE

University of California, San Francisco

Information Provided By

University of California, San Francisco

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP