NCT01776346Unknown不适用
Barrett's Esophagus Patient Registry
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Progression to esophageal adenocarcinoma
研究概览
简要总结
The ultimate goal of the Barrett's Esophagus Patient Registry is to help develop more effective targeted screening strategies and treatment options for Barrett's esophagus and esophageal adenocarcinoma (EAC). We plan to do by developing a registry that will serve as a platform. Examples of analyses could include identifying genetic determinants and biomarkers that predict BE, progression of BE to EAC, as well as the response to therapies.
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
- •Barrett's (BE): Patients who have Barrett's esophagus (all stages: Barrett's metaplasia, low-grade dysplasia, high-grade dysplasia) based upon standard endoscopic and histologic criteria.
- •Adenocarcinoma (EAC): Patients who have esophageal adenocarcinoma.
- •The control cohort will include patients ages 18 and older with no prior history of BE and EAC. These may include patients who are being seen or have been previously seen at MGH GI Associates for conditions including gastroesophageal reflux disease, peptic esophagitis, eosinophilic esophagitis, esophageal motility disorders such as achalasia and nutcracker esophagus.
排除标准
- •Inability or unwillingness to provide blood samples.
- •History of known bleeding disorders.
- •Currently awaiting organ transplantation.
- •Having an acute or severe chronic illness such as congestive heart failure or any other condition that would prohibit performing the endoscopy.
结局指标
主要结局
Progression to esophageal adenocarcinoma
时间窗: 5 years (on average although follow-up will continue)
次要结局
- Identify and validate genetic determinants that predict progression of BE to EAC and predict response to BE therapy(5 years on average)
- Evaluate the natural history of BE with and without treatment based on clinical, functional and economic outcomes of the cases(5 years on average)
研究者
Chin Hur
Principal Investigator; MD, MPH
Massachusetts General Hospital
研究点 (1)
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