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

• ClinicalTrials.gov Identifier: NCT00683371
• Recruitment Status: Completed
• First Posted: May 23, 2008
• Last Update Posted: February 5, 2020
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

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	Not Applicable

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 (Clinical Trial)
• 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: October 2007
• Actual Primary Completion Date: April 30, 2008
• Actual Study Completion Date: April 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.

Outcome Measures

Primary Outcome Measures :

1. 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. ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, California

University of California, San Francisco, Dept of Otolaryngology-HNS

San Francisco, California, United States, 94143

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
• ClinicalTrials.gov Identifier: NCT00683371
• Other Study ID Numbers: H43796-31316-03
• First Posted: May 23, 2008
• Last Update Posted: February 5, 2020
• Last Verified: January 2020

Keywords provided by University of California, San Francisco:

Chronic Rhinosinusitis; Sinus Disease; Allergy; Maxillary Sinus; Microarray

Additional relevant MeSH terms:

Sinusitis; Maxillary Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases