Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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
排除标准
- •Control patients with any evidence of CRS, by history, survey, or imaging criteria would be excluded.
研究组 & 干预措施
1
10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery
干预措施: Specimen collection (Procedure)
2
10 patients without sinus disease will have three specimens collected from the maxillary sinus during surgery.
干预措施: Specimen collection (Procedure)
结局指标
主要结局
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.
时间窗: Immediate Preoperative period.
次要结局
- 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)