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| Descriptive Information Fields | |||||||||
| Brief Title † | 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 | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Diagnostic, Non-Randomized, Single Blind (Investigator), Parallel Assignment | ||||||||
| Primary Outcome 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. [ Time Frame: Immediate Preoperative period. ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome 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. [ Time Frame: Immediate preoperative period ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Maxillary Sinusitis | ||||||||
| Intervention † | Procedure: Specimen collection | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 20 | ||||||||
| Start Date † | October 2007 | ||||||||
| Completion Date | September 2008 | ||||||||
| Eligibility Criteria † | Inclusion Criteria (CRS patients):
Inclusion Criteria (Control patients):
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00683371 | ||||||||
| Organization ID | H43796-31316-01 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | University of California, San Francisco | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | University of California, San Francisco | ||||||||
| Verification Date | May 2008 | ||||||||
| First Received Date † | May 21, 2008 | ||||||||
| Last Updated Date | May 22, 2008 | ||||||||
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