Rapid Assessment of Esophageal Adenocarcinoma Risk Test (REACT)

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

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.

Study Overview

• Status: Suspended
• Conditions: Barrett Esophagus; Esophageal Adenocarcinoma
• Intervention / Treatment: Device: Cytosponge

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Cytosponge Test; This arm will include individuals without formal diagnosis of Barrett's esophagus.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participate Rate	Participation rate is defined as the proportion of patients who agree to undergo Cytosponge testing among number of eligible patients offered Cytosponge testing.	1 Day
Patient Tolerability determined by Score on Likert Scale	After undergoing the Cytosponge test, subjects will be asked to take a "Cytosponge Post-Procedure Questionnaire" to assess tolerability using a Likert scale from 1 (no discomfort) to 10 (severe discomfort) and whether they would be willing to undergo Cytosponge testing again (yes/no). The scale for each question is rated 1 to 10. Lower scores are "better" (greater tolerability for that particular measure), higher scores are "worse" (less tolerable for that particular measure). Each question on the questionnaire will be assessed independently (i.e. one score per question). No total scores are calculated.	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Predictive Value (PPV)	The PPV is the proportion of patients with endoscopic and histologic evidence of Barrett's esophagus on upper endoscopy from the total number of patients with TFF3-positive Cytosponge test who undergo a follow up endoscopy.	1 Day
Number of Adverse Events (AEs)	Total number of all AEs related to Cytosponge testing	1 Day
Number of Serious Adverse Events (SAEs)	Total number of all SAEs related to Cytosponge testing	1 Day

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Julian Abrams, MD, MPH, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: GERD; Cytosponge
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Precancerous Conditions; Adenocarcinoma; Esophageal Neoplasms; Barrett Esophagus
• Other Study ID Numbers: AAAR5884

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No