NCT03366012

Rapid Assessment of Esophageal Adenocarcinoma Risk Test

The Acceptability of a Rapid Assessment of Esophageal Adenocarcinoma Risk Test (REACT)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Barrett Esophagus
• Esophageal Adenocarcinoma

Interventions

Type	Name	Description
DEVICE	Cytosponge	The Cytosponge consists of a 3cm diameter, polyester, medical grade spherical sponge on a string, compressed within a gelatin capsule. The capsule is swallowed while the patient or the research specialist holds onto the string. After 3-5 minutes the gelatin capsule dissolves allowing the spherical sponge to expand. The sponge is then retrieved by gently pulling on the string, thus collecting cells along the passageway through the entire length of the esophagus. The sample is then put into a preservative to be processed for immunohistochemical testing for trefoil factor 3 (TFF3) to determine diagnosis of Barrett's esophagus.

Timeline

• Start date: 2018-08-01
• Primary completion: 2023-05-19
• Completion: 2023-05-19
• First posted: 2017-12-08
• Last updated: 2024-11-08
• Results posted: 2024-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study