Clinical trial NCT00683371: Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis
Official title: Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Sinusitis
Keywords: Chronic Rhinosinusitis
Sinus Disease
Allergy
Maxillary Sinus
Microarray
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Immediate Preoperative period.
Secondary outcomes:
measure: 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.
timeFrame: Immediate preoperative period
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco, Dept of Otolaryngology-HNS
state: California
Study officials:
affiliation: University of California, San Francisco
name: Andrew Goldberg, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: