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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00683371
Enrollment
20
Registered
2008-05-23
Start date
2007-10-31
Completion date
2008-04-30
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Sinusitis

Keywords

Chronic Rhinosinusitis, Sinus Disease, Allergy, Maxillary Sinus, Microarray

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.

Interventions

PROCEDURESpecimen 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.

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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. 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026