EsophaCap for the Detection of Early Esophageal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 2
- 主要终点
- Difference in methylation of gene markers to discriminate gastric cancer from non-pathological esophageal squamous and gastric cardia tissue.
研究概览
简要总结
This study is to identify potential biomarkers for the early detection of Barrett's Esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma), and gastric cancer via sponge cytology.
详细描述
This study is to identify potential biomarkers for the early detection of Barrett's Esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma). Esophageal and gastric cytology will be collected via sponge capsule. Candidate genes will be tested with DNA isolated from these samples in order to identify optimal biomarkers to differentiate between Barrett's esophagus and esophageal/gastric cancer versus normal esophageal/gastric tissue.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Undergoing esophagogastroduodenoscopy at Johns Hopkins Hospital from 1/2016 to 12/2025
- •Age greater than 18 years
- •Patients must be able to swallow a capsule
排除标准
- •Patients in either arm with extra-esophageal malignancies including head and neck and gastric cancer
- •Patients who have undergone esophagectomy
- •Patients who have undergone radiation to the chest
- •Patients who are younger than 18
- •Patients with esophageal stents
- •Patients with esophageal strictures disabling passage of the capsule
结局指标
主要结局
Difference in methylation of gene markers to discriminate gastric cancer from non-pathological esophageal squamous and gastric cardia tissue.
时间窗: 1 day
Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in gastric cancer versus control in order to differentiate between subjects who have gastric cancer and those who do not. This is measure using methylation index and the calculated probability score from different methylation index values.
Difference in methylation of gene markers to discriminate esophageal carcinoma from non-pathological esophageal squamous and gastric cardia tissue.
时间窗: 1 day
Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in esophageal cancer versus control in order to differentiate between subjects who have esophageal cancer and those who do not. This is measure using methylation index and the calculated probability score from different methylation index values.
Difference in methylation of gene markers to discriminate Barrett's esophagus from non-pathological esophageal squamous and gastric cardia tissue.
时间窗: 1 day
Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in Barrett's esophagus versus control in order to differentiate between subjects who have Barrett's esophagus and those who do not have Barrett's esophagus. This is measure using methylation index and the calculated probability score from different methylation index values.
次要结局
- Sensitivity of candidate biomarker HPP1(1 day)
- Specificity of candidate biomarker p16(1 day)
- Sensitivity of candidate biomarker NELL1(1 day)
- Sensitivity of candidate biomarker AKAP12(1 day)
- Specificity of candidate biomarker NELL1(1 day)
- Sensitivity of candidate biomarker TAC1(1 day)
- Specificity of candidate biomarker AKAP12(1 day)
- Sensitivity of candidate biomarker p16(1 day)
- Specificity of candidate biomarker TAC1(1 day)
- Specificity of candidate biomarker HPP1(1 day)