Ultralong-segment Barrett's Esophagus: Towards a Capsule-sponge Surveillance Strategy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Concordance between EndoSign and upper endoscopy to detect dysplasia and/or esophageal adenocarcinoma
研究概览
简要总结
The purpose of this study is to evaluate the Endosign capsule sponge test as a novel surveillance method in patients with an ultralong-segment Barrett's esophagus.
详细描述
In this study we will investigate the concordance between the Endosign capsule sponge test and esophagogastroduodenoscopy (EGD) by an expert endoscopist to detect dysplasia and/or esophageal adenocarcinoma (EAC) in patients with an ultralong-segment Barrett's esophagus. Patients will receive both the Endosign test and an EGD, after which we will compare both outcomes. To detect dysplasia and/or EAC on the cells collected by the Endosign test, we will look at cellular atypia and use p53 immunohistochemistry and novel biomarkers. In the future the Endosign test could perhaps replace EGD in the surveillance of Barrett's esophagus patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Any participant 18 years and above, with ultralong-segment Barrett's esophagus and clinically fit for an endoscopy
- •Ability to provide informed consent
排除标准
- •Individuals with a diagnosis of an oro-pharynx, esophageal or gastro-esophageal tumor (T2 staging and above), or symptoms of dysphagia
- •Esophageal varices or stricture requiring dilatation of the esophagus
- •Individuals who have had a cerebrovascular event < 6 months prior where their swallowing has been affected
- •Patients who have had previous treatments such as Photodynamic therapy (PDT), Radiofrequency ablation (RFA) or Argon Plasma Coagulation (APC) for dysplastic Barrett's esophagus
- •Participants who are unable to provide informed consent
- •Participants under age 18 years
研究组 & 干预措施
Study group
Subjects will receive the EndoSign test prior to their scheduled clinically indicated upper endoscopy by an expert endoscopist, per routine standard of care. Additional biopsies will be taken and 10cc of blood will be collected from the cannula used for sedation. Subjects will also receive three questionnaires regarding baseline characteristics, gastrointestinal symptoms and acceptability.
干预措施: EndoSign (Device)
结局指标
主要结局
Concordance between EndoSign and upper endoscopy to detect dysplasia and/or esophageal adenocarcinoma
时间窗: 3 years
We will determine the concordance between the EndoSign test and upper endoscopy by an expert endoscopist to detect dysplasia and/or esophageal adenocarcinoma in patients with an ultralong-segment Barrett's esophagus.
次要结局
- Patient rating of both the EndoSign procedure and upper endoscopy on an experience scale(3 years)
- Sensitivity & specificity(3 years)
- Additional value of p53 immunohistochemistry(3 years)
- Accuracy of a new risk stratification model for neoplastic progression(3 years)
- Accuracy of a new shallow Whole Genome Sequencing assay to predict neoplastic progression(3 years)
- Validation of the sensitivity of a current methylation-based sequencing approach to predict neoplastic progression(3 years)
研究者
Judith Honing
Principal Investigator
Erasmus Medical Center