Detection of Barrett s Esophagus in Patients Without Gastroesophageal Reflux Disease (GERD) Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Positive Predictive Value (PPV) of EC/EG in a Non-GERD Population That Has Three or More Non-GERD Risk Factors for BE.
研究概览
简要总结
The purpose of this study is to develop a method to detect Barrett's esophagus (BE) in individuals with a new office-based diagnostic test.
详细描述
This study will investigate whether using EsoCheck/EsoGuard(EC/EG) can detect BE in individuals at risk for BE who are currently not being detected and are not undergoing routine esophago-gastro-duodenoscopy (EGD)
BE can only be diagnosed by performing upper endoscopy. Up to 500 adults who have risk factors for BE but do not have chronic heartburn or regurgitation will be enrolled in this study. This will include the EsoCheck/EsoGuard determination along with the upper endoscopy for qualifying EsoGuard negative subjects
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No known coagulopathy, no known esophageal varices.
- •No significant dysphagia or odynophagia
- •Absence of chronic GERD, defined as five or more years of heartburn or regurgitation with symptoms at least once a week when not on medications for GERD symptoms.
- •Subjects to qualify must meet criterion 3, be over age 50, and have two additional risk factors for BE (white race, central obesity defined as waist size >35 inches for women and >40 inches for men, male gender, current smoker or smoking history >10 pack years, confirmed family history in at least two members with one being a first degree relative).
排除标准
- •History of prior EGD procedure
- •Inability to provide written informed consent
- •History of weekly of more frequent heartburn or regurgitation for five or more years
- •On anti-coagulant drug(s)that cannot be temporarily discontinued or coagulopathy with international normalized ratio (INR) > 1.5
- •Known history of esophageal varices or esophageal stricture
- •Any contraindication, as deemed inInvestigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGDprocedure,and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
- •History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
- •Oropharyngeal tumor
- •History of esophageal or gastric surgery, with exception on uncomplicated surgical fundoplication procedure
- •History of myocardial infarction or cerebrovascular accident within past 6 months
研究组 & 干预措施
EC/EG & EGD
Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay
If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected)
If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent
干预措施: EsoCheck/EsoGuard (EC/EG) (Diagnostic Test)
EC/EG & EGD
Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay
If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected)
If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent
干预措施: Esophago-gastro-duodenoscopy (EGD) (Diagnostic Test)
结局指标
主要结局
Positive Predictive Value (PPV) of EC/EG in a Non-GERD Population That Has Three or More Non-GERD Risk Factors for BE.
时间窗: Up to 2 months
PPV of EC/EG in a non-GERD population that has three or more non-GERD risk factors for BE. Participants who are at risk will be offered EC/EG. Those who are positive will undergo subsequent EGD PPV = (EC/EG positive \& EGD positive) / ((EC/EG positive \& EGD positive) + (EC/EG positive \& EGD negative))
Proportion of Participants Negative Via EC/EG Who Subsequently Are Proven Negative Via EGD
时间窗: Up to 2 months
Negative Predictive Value (NPV): Proportion of participants negative via EC/EG who subsequently are proven negative via EGD. This will be measured by offering EGD to a proportion of patients who are EC/EG negative.
次要结局
未报告次要终点