Rapid Assessment of Esophageal Adenocarcinoma Risk Test

NCT ID: NCT03366012

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2023-05-19

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.

Conditions

Barrett Esophagus; Esophageal Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Cytosponge Test

This arm will include individuals without formal diagnosis of Barrett's esophagus.

Group Type: OTHER

Cytosponge

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Julian A Abrams, MD

Associate Professor of Medicine and Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julian Abrams, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAR5884

Identifier Type: -

Identifier Source: org_study_id