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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00683371 |
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 |
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Maxillary Sinusitis |
Procedure: Specimen collection |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Single Blind (Investigator), Parallel Assignment |
Official Title: | Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis |
Estimated Enrollment: | 20 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery
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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.
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2: Placebo Comparator
10 patients without sinus disease will have three specimens collected from the maxillary sinus during surgery.
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria (CRS patients):
Inclusion Criteria (Control patients):
Exclusion Criteria:
Contact: Wendy Ma | 415-353-2870 | wma@ohns.ucsf.edu |
Contact: Andrew Goldberg, MD, MSCE | 415-353-2757 | agoldberg@ohns.ucsf.edu |
United States, California | |
University of California, San Francisco, Dept of Otolaryngology-HNS | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Wendy Ma 415-353-2870 wma@ohns.ucsf.edu | |
Contact: Andrew Goldberg, MD, MSCE 415-353-2757 agoldberg@ohns.ucsf.edu | |
Principal Investigator: Andrew Goldberg, MD, MSCE |
Principal Investigator: | Andrew Goldberg, MD, MSCE | University of California, San Francisco |
Responsible Party: | University of California, San Francisco, Department of Otolaryngology-HNS ( Andrew N. Goldberg, MD, MSCE ) |
Study ID Numbers: | H43796-31316-01 |
Study First Received: | May 21, 2008 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00683371 |
Health Authority: | United States: Institutional Review Board |
Chronic Rhinosinusitis Sinus Disease Allergy Maxillary Sinus Microarray |
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Maxillary Sinusitis Sinusitis |
Paranasal Sinus Diseases Nose Diseases |