The Acceptability of a Rapid Assessment of Esophageal Adenocarcinoma Risk Test (REACT)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Participation Rate
研究概览
简要总结
This study aims to evaluate the acceptability of a new non-invasive screening device to test for Barrett's esophagus. The investigators will prospectively enroll 100 patients to undergo Cytosponge testing. The time of involvement for an individual will range from 2 weeks to 2 months, depending on the results of the Cytosponge test and time to follow up endoscopy, if indicated.
详细描述
The incidence of esophageal adenocarcinoma (EAC) has risen over the past half century and continues to have a dismal prognosis. Even though it has been established that Barrett's esophagus (BE) is the precursor lesion to EAC, more than 90% of EAC patients are never diagnosed with BE beforehand. Thus, the opportunity is missed to identify most patients at high risk for EAC who could benefit from surveillance and early endoscopic therapy, which in turn may lower EAC mortality. Upper endoscopy is the only means to diagnose BE, yet widespread endoscopic screening is impractical and expensive. There is an urgent need to develop minimally-invasive methods of BE screening that can be easily performed in the primary care setting to allow for efficient and cost-effective interventions to decrease EAC mortality.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 50-75 and at least one of the following:
- •Gastro-esophageal reflux disease (GERD)* or
- •Family history (first degree relative) with Barrett's esophagus or esophageal adenocarcinoma or
- •Both body mass index (BMI) ≥30 or
- •A history of cigarette smoking (at least 10 pack years)
- •Ages 50-75 and GERD* and at least one of the following:
- •Family history (first degree relative) with Barrett's esophagus or esophageal adenocarcinoma or
- •BMI ≥30 or
- •A history of cigarette smoking (at least 10 pack years)
排除标准
- •History of gastric or esophageal cancer
- •History of esophageal surgery
- •Known untreated esophageal stricture or uninvestigated dysphagia
- •Previous upper endoscopy within 10 years
- •Cancer within 3 years except for non-melanoma skin cancer
- •Portal hypertension, with or without known varices
- •Uncontrolled coagulopathy
- •Uncontrolled major comorbid illness
- •Inability to tolerate or contraindication to upper endoscopy
- •Inability to give informed consent
- •GERD defined as either a history of frequent heartburn or fluid regurgitation symptoms (at least weekly for 6 months) or regular use of proton pump inhibitors or histamine-2 receptor antagonists.
研究组 & 干预措施
Cytosponge Test
This arm will include individuals without formal diagnosis of Barrett's esophagus.
干预措施: Cytosponge (Device)
结局指标
主要结局
Participation Rate
时间窗: 1 Day
Participation rate is defined as the percent of patients who agree to undergo Cytosponge testing among number of eligible patients offered Cytosponge testing.
Patient Tolerability Determined by Score on Likert Scale
时间窗: 1 Day
After undergoing the Cytosponge test, subjects will be asked to take a "Cytosponge Post-Procedure Questionnaire" to assess tolerability using a Likert scale from 1 (no discomfort) to 10 (severe discomfort) and whether they would be willing to undergo Cytosponge testing again (yes/no). The scale for each question is rated 1 to 10. Lower scores are "better" (greater tolerability for that particular measure), higher scores are "worse" (less tolerable for that particular measure). Each question on the questionnaire will be assessed independently (i.e. one score per question). No total scores are calculated.
次要结局
- Number of Serious Adverse Events (SAEs)(1 Day)
- Positive Predictive Value (PPV)(1 Day)
- Number of Adverse Events (AEs)(1 Day)
研究者
Julian A Abrams, MD
Associate Professor of Medicine and Epidemiology
Columbia University