Rapid Assessment of Esophageal Adenocarcinoma Risk Test

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.

Inclusion Criteria:

Males:

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)

Females:

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)

Exclusion Criteria:

- 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.