Evaluation of MicroRNA Expression in Blood and Cytology Specimens as a Novel Method for Detecting Barrett's Esophagus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of tissue and serum microRNA expression by digital polymerase chain reaction for diagnosis of BE neoplasia
研究概览
简要总结
The primary purpose of this study is to test new methods to diagnose BE in time before it turns into advanced cancer. Once BE is diagnosed, the current standard of care is to monitor the disease so that complication such as cancer can be diagnosed early. The two new methods the investigators are evaluating are: a) blood test and b) brush test of the food pipe. The investigators will collect blood, bile and cells from the food pipe and stomach and measure for a biomarker called microRNA (miRNA). In the future, measurements of microRNA biomarkers could help the doctors figure out which patients are at increased risk for cancer of the esophagus.
详细描述
The investigators will collect serum, bile and esophageal cells (using cytology devices) from consenting subjects. The investigators have previously identified BE specific miRNA that will be tested on the cytology specimens. These are miRNAs -192-5p, -215-5p and -194-5p. The investigators have also identified serum microRNAs in whole serum and exosomes by sequencing to study further. The investigators will also evaluate miRNA expression within biliary exosomes for the first time in patients with reflux related diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patient age: > 18 years
- •Ability to provide written, informed consent
排除标准
- •Pregnancy or planning a pregnancy
- •History of nasal, esophageal & gastric surgery
- •History of recurrent epistaxis or nasal trauma
- •Subjects with a history of unresolved drug or alcohol dependency
- •Inability to obtain biopsies due to a coagulopathy, varices, thrombocytopenia, etc.
- •Subjects with inadequate cytology specimens will not undergo repeat test and will be excluded from the study
- •Inability to provide written informed consent
- •Inability to discontinue drugs such as Plavix
- •Advanced chronic liver disease
- •Severe uncontrolled coagulopathy
- •Active cancer in any organ over the past 3 years.
结局指标
主要结局
Sensitivity and specificity of tissue and serum microRNA expression by digital polymerase chain reaction for diagnosis of BE neoplasia
时间窗: 1-3 years
The two main outcomes are the diagnostic accuracy of tissue and serum microRNA for the the diagnosis of Barrett's esophagus compared to endoscopy.
次要结局
- Differences in the microRNA expression of biliary exosomes between GERD, Barrett's esophagus and Cancer(1-3 years)
研究者
Ajay Bansal
Associate Professor of Medicine and Staff Gastroenterologist
Midwest Biomedical Research Foundation