A Comparison of microRNA Samples in Patients With Nasal Polyps and Aspirin Exacerbated Respiratory Disease and Those With Nasal Polyps Only
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Positibe Group: 2 fold or greater will be identified as differntially expressed MiRNA.
研究概览
简要总结
We hypothesize that the miRNA expression in subjects with nasal polyps and Aspirin-exacerbated respiratory disease (AERD) differs from the miRNA expressed in subjects with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD).
详细描述
Nasal epithelial tissue will be collected from the inferior nasal turbinates of ten subjects with nasal polyps and AERD disease and from the inferior turbinates of ten subjects with nasal polyps but without AERD. A rhinoprobe™ will be used to collect this epithelial tissue. These samples will be analyzed by miRNA assay to determine if there is a difference in mircroRNA expression between the two subject groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages eligible for study: 18 to 70 years
- •Genders eligible for study: male and female
- •Signed and dated written informed consent is obtained prior to study
- •Subjects have a physician diagnosis of nasal polyps without AERD or physician diagnosis of nasal polyps with AERD. The diagnosis of aspirin sensitive asthma must be present for a minimum of three months. If the medical history is indeterminate either an aspirin challenge will be required to confirm or rule out the diagnosis. An aspirin challenge is a protocol that can safely be performed as an out patient procedure with close supervision.
排除标准
- •Pregnant and/or lactating females.
- •Current tobacco use.
- •Severe psychiatric illness.
- •Current illicit substance use or dependence and/or abuse of alcohol.
- •Primary or secondary immunodeficiency.
- •Any clinically significant uncontrolled medical condition that would put the patient at risk.
结局指标
主要结局
Positibe Group: 2 fold or greater will be identified as differntially expressed MiRNA.
时间窗: No time frame noted
5 total groups
Negative Group: MiRNAs are absent from both groups
时间窗: No time frame noted
5 total groups
次要结局
未报告次要终点
研究者
Dennis Ledford
Principal Investigator
University of South Florida