Clinical trial NCT03366012: Rapid Assessment of Esophageal Adenocarcinoma Risk Test
Official title: The Acceptability of a Rapid Assessment of Esophageal Adenocarcinoma Risk Test (REACT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Barrett Esophagus
Esophageal Adenocarcinoma
Keywords: Cytosponge
GERD
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 51
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participation Rate
timeFrame: 1 Day
measure: Patient Tolerability Determined by Score on Likert Scale
timeFrame: 1 Day
Secondary outcomes:
measure: Positive Predictive Value (PPV)
timeFrame: 1 Day
measure: Number of Adverse Events (AEs)
timeFrame: 1 Day
measure: Number of Serious Adverse Events (SAEs)
timeFrame: 1 Day
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Julian Abrams, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: