Rapid Assessment of Esophageal Adenocarcinoma Risk Test (REACT)

Columbia University

Status

Terminated

Conditions

Barrett Esophagus

Esophageal Adenocarcinoma

Treatments

Device: Cytosponge

Study type

Interventional

Funder types

Other

Identifiers

NCT03366012

AAAR5884

Details and patient eligibility

About

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.

Full description

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.

Enrollment

51 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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.