Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic |
| Official Title: | Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis |
- 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 ]
- 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 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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 |
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| United States, California | |
| University of California, San Francisco, Dept of Otolaryngology-HNS | |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: | Andrew Goldberg, MD, MSCE | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | Andrew Goldberg, Professor, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00683371 History of Changes |
| Other Study ID Numbers: | H43796-31316-03 |
| Study First Received: | May 21, 2008 |
| Last Updated: | September 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
Chronic Rhinosinusitis Sinus Disease Allergy Maxillary Sinus Microarray |
Additional relevant MeSH terms:
|
Maxillary Sinusitis Sinusitis Paranasal Sinus Diseases Nose Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013