Rapid Assessment of Esophageal Adenocarcinoma Risk Test

Not Applicable

Terminated

• Conditions: Esophageal Adenocarcinoma; Barrett Esophagus
• Interventions: Device: Cytosponge

• Registration Number: NCT03366012
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-08
• Study Start: 2018-08-01
• Primary Completion: 2023-05-19
• Study Completion: 2023-05-19
• Status Verified: 2024-10
• Results First Submitted: 2024-10-16
• Results First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Results First Posted: 2024-11-08
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cytosponge Test	Cytosponge	This arm will include individuals without formal diagnosis of Barrett's esophagus.

Primary Outcome Measures

Name	Time	Method
Participation Rate	1 Day	Participation rate is defined as the percent of patients who agree to undergo Cytosponge testing among number of eligible patients offered Cytosponge testing.
Patient Tolerability Determined by Score on Likert Scale	1 Day	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.

Secondary Outcome Measures

Name	Time	Method
Number of Serious Adverse Events (SAEs)	1 Day	Total number of all SAEs related to Cytosponge testing
Positive Predictive Value (PPV)	1 Day	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.
Number of Adverse Events (AEs)	1 Day	Total number of all AEs related to Cytosponge testing

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States