Office Based Screening Test for Barrett's Esophagus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 4
- 主要终点
- Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey
研究概览
简要总结
This pilot clinical trial studies non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus in screening for Barrett esophagus, a condition where the lining of the esophagus has changed or been replaced with abnormal cells that may lead to cancer. The non-endoscopic inflatable balloon for the esophagus is a capsule balloon that brushes against the walls of the esophagus to collect esophageal samples. Non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus may help doctors find Barrett esophagus sooner, when it may be easier to treat.
详细描述
PRIMARY OBJECTIVES:
I. To determine acceptability of non-endoscopic balloon brushing of esophagus.
II. To demonstrate successful performance of the methylation of vimentin (mVIM) assay in balloon brushings from subjects with and without Barrett's Esophagus (BE).
III. To examine molecular and histological factors that might lead to false negative and false positive mVIM assays in BE screening.
IV. To assay additional methylated deoxyribonucleic acid (DNA) biomarkers that might improve the sensitivity and specificity of mVIM in balloon brushings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Patients are undergoing clinically indicated esophagogastroduodenoscopy (EGD)
- •Patients can provide informed consent
- •Patients have no known coagulopathy and no known history of esophageal varices
排除标准
- •Patients are not undergoing clinically indicated EGD
- •Patients have known coagulopathies or history of esophageal varices
- •Patients do not have the ability to give informed consent
结局指标
主要结局
Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey
时间窗: At completion of study procedure (up to 60 minutes)
Mean tolerance score as assessed by 'tolerance survey' with scores ranging from 0 to 50 with higher scores indicating worse tolerance of interventional balloon device. Subscales include anxiety, pain, choking, gagging, and overall tolerance, with each domain scores ranging from 0 to 10, with higher scores indicating worse tolerance of interventional balloon device.
Sensitivity of the mVIM Assay in Balloon Brushings From Participants With BE
时间窗: Up to 1 year
Sensitivity of the mVIM assay in balloon brushings from participants with BE as measured by true positives determined by biomarker (mVIM and mCCNA1) analyses of corresponding esophageal balloon derived samples compared to initial diagnosis. The presence of at least 1% of methylated VIM in DNA extracted from the esophageal sampling balloon will be considered a positive assay.
Average Methylation of Zinc Finger Protein 793 Assay
时间窗: Up to 7 months
Average methylation of zinc finger protein 793 assay
Specificity of the mVIM Assay in Balloon Brushings From Control Participants With no BE Diagnosis
时间窗: Up to 1 year
Specificity of the mVIM assay in balloon brushings from control subjects with BE as measured by true negatives determined by biomarker (mVIM and mCCNA1) analyses of corresponding esophageal balloon derived samples compared to initial control status. The presence of at least 1% of methylated VIM in DNA extracted from the esophageal sampling balloon will be considered a positive assay.
Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays
时间窗: Up to 7 months
Average methylation of methylated beta-1,3-glucuronyltransferase 2 assays
Performance of the mVIM Assay in Balloon Brushings From Subjects Without BE
时间窗: Up to 7 months
Performance of the mVIM assay in balloon brushings from subjects without BE
次要结局
未报告次要终点