Utility Of Mutational Load As A Predictor For Endoscopic Treatment Response In Barrett's Esophagus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Correlation of Mean Mutational Load (ML) and Treatment Resistance
研究概览
简要总结
To evaluate association between mutational load (ML) from esophageal biopsy specimens in pre-endoscopic eradication therapy (EET) in Barrett's Esophagus (BE) or Intramucosal adenocarcinoma (IMC) patients and treatment resistance (treatment resistance will be defined as disease recurrence and/or need for additional intervention such as increased acid suppression, need for anti-reflux surgery, or use of alternate ablative modality).
详细描述
Potential subjects will be identified via protocol and Institutional Review Board (IRB) methods prior to obtaining written informed consent. Once written informed consent is obtained, subjects will continue with planned routine care upper endoscopy. During the first study visit an upper endoscopy will be performed. At this visit, research specimens will be obtained for mutational load (ML) analysis and gastroenterologist (GI) pathologist diagnosis for the presence of adenocarcinoma or degrees of dysplasia. ML will be correlated to the pathology diagnosis on this research biopsy. Subjects will then undergo EET per routine standard of care at the treating institution until CEIM achieved. Subjects will be followed (data collection only) during treatment period until CEIM is achieved. After subjects reach CEIM, four additional research biopsies will be collected, from the midpoint of previous BE site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •No prior history of endoscopic treatment therapy for BE
- •Previously untreated "treatment naïve" disease history with confirmed histopathology analysis of at least one of the following:
- •Low- or high-grade dysplastic BE (history of endoscopic mucosal resection (EMR)) is allowable or
- •Intramucosal adenocarcinoma (IMC)
- •BE lesion length of at least: C0, M1
- •At least 18 years of age at time of consent
- •Able and willing to provide written informed consent
- •Able and willing to comply with required study procedures and follow-up schedule
排除标准
- •History of endoscopic intervention for the treatment of gastroesophageal reflux disease (GERD), BE, or IMC (prior EMR is allowable)
- •Current esophageal stenosis/stricture preventing advancement of a therapeutic scope or significant esophageal anatomic abnormalities (masses, obstructive lesions, etc.)
- •Dysplasia of intestinal metaplasia (IM) confined only to the gastric cardia (BE Prague Criteria: C0M0)
- •Uncontrolled coagulopathy
- •Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
- •Known portal hypertension, visible esophageal varices, or history of esophageal varices
- •Previous esophagectomy surgery involving the gastroesophageal junction (history of a fundoplication is OK)
- •General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation
- •Subject has any condition that, in the opinion of the investigator or sponsor, would interfere with accurate interpretation of the study endpoints or preclude participation in the trial
结局指标
主要结局
Correlation of Mean Mutational Load (ML) and Treatment Resistance
时间窗: Baseline until Month 24
Treatment resistance will be assessed as a dichotomous variable and defined as those with one or more of the following features: disease recurrence, need for increased acid suppression, need for anti-reflux surgery, or use of alternate ablative modality. The association between pre-EET ML and treatment resistance will be calculated using the difference between the two mean ML values.
次要结局
- Correlation of Mutational Load and Dysplasia Category(Day 1, at enrollment)
- Correlation of Mutational Load and Number of Ablation Sessions to CEIM(From Baseline until the date of first documentation of CEIM, assessed up to 24 Months)
- Correlation of Mutational Load and Stricture Formation(From Baseline until the date of first documentation of CEIM, assessed up to 24 Months)